Trial Outcomes & Findings for Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer (NCT NCT00977574)
NCT ID: NCT00977574
Last Updated: 2026-04-29
Results Overview
PFS (Progression free survival) is defined as the duration of time from date of study entry to time of progression or death, whichever occurs first. Patients with a status of alive, progression-free are censored at their date of last follow-up. To lessen the potential for bias in the progression evaluation times between treatment arms and historical controls, progression/death times will be grouped over 6 18-week time intervals. Progressions are carried forward to the end of the interval. All progressions or deaths occurring after the 6th 18-week interval are censored at 25 months for this analysis. Study NCT00977574
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
349 participants
Primary outcome timeframe
at 25 months
Results posted on
2026-04-29
Participant Flow
Accrual of 349 patients from 48 main members and CCOP sites began on 9/14/2009 and completed on 01/09/2012 in 28 months; 5 months longer than expected. There were 11 patients deemed ineligible by central review most for reasons related to pathologic diagnosis. Ten patients refused all protocol treatment.
Participant milestones
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
116
|
115
|
118
|
|
Overall Study
COMPLETED
|
112
|
113
|
114
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
4
|
Reasons for withdrawal
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
|---|---|---|---|
|
Overall Study
Never Treated
|
4
|
2
|
4
|
Baseline Characteristics
Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
n=116 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
n=115 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
n=118 Participants
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
30-39 years
|
2 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
7 Participants
n=73 Participants
|
|
Age, Customized
40-49 years
|
6 Participants
n=9 Participants
|
5 Participants
n=24 Participants
|
8 Participants
n=23 Participants
|
19 Participants
n=73 Participants
|
|
Age, Customized
50-59 years
|
36 Participants
n=9 Participants
|
35 Participants
n=24 Participants
|
19 Participants
n=23 Participants
|
90 Participants
n=73 Participants
|
|
Age, Customized
60-69 years
|
48 Participants
n=9 Participants
|
50 Participants
n=24 Participants
|
57 Participants
n=23 Participants
|
155 Participants
n=73 Participants
|
|
Age, Customized
70-79 years
|
22 Participants
n=9 Participants
|
22 Participants
n=24 Participants
|
28 Participants
n=23 Participants
|
72 Participants
n=73 Participants
|
|
Age, Customized
>=80 years
|
2 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
6 Participants
n=73 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=9 Participants
|
115 Participants
n=24 Participants
|
118 Participants
n=23 Participants
|
349 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
PRIMARY outcome
Timeframe: at 25 monthsPopulation: All enrolled patients
PFS (Progression free survival) is defined as the duration of time from date of study entry to time of progression or death, whichever occurs first. Patients with a status of alive, progression-free are censored at their date of last follow-up. To lessen the potential for bias in the progression evaluation times between treatment arms and historical controls, progression/death times will be grouped over 6 18-week time intervals. Progressions are carried forward to the end of the interval. All progressions or deaths occurring after the 6th 18-week interval are censored at 25 months for this analysis. Study NCT00977574
Outcome measures
| Measure |
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
n=118 Participants
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
n=116 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
n=115 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
|---|---|---|---|
|
Number of Participants Who Progressed or Died by 25 Months From Enrollment
|
88 Participants
|
86 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: Median of 10 cycles of treatment plus 30 daysPopulation: Treated patients
Outcome measures
| Measure |
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
n=114 Participants
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
n=112 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
n=113 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
|---|---|---|---|
|
Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms.
Any Adverse Event, Any Grade
|
114 Participants
|
112 Participants
|
113 Participants
|
|
Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms.
Any Adverse Event, Grades >= 3
|
109 Participants
|
105 Participants
|
111 Participants
|
|
Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms.
Any Adverse Event, Grade 5
|
6 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Time from date of study entry to time of death or the date of last contact, assessed up to 5 yearsPopulation: All enrolled patients
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
n=118 Participants
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
n=116 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
n=115 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
|---|---|---|---|
|
The Median Duration of Overall Survival for Each of the Three Arms.
|
25.2 months
Interval 18.8 to 32.1
|
34 months
Interval 26.0 to 51.4
|
25 months
Interval 18.5 to 29.6
|
SECONDARY outcome
Timeframe: Imaging was done every 3 cycles and at any other time clinically indicated. Imaging was required every 9 weeks until progression or initiation on non protocol therapy. After 2 years of protocol therapy or follow up, CT scan or MRI was every 3 monthsPopulation: Enrolled patients with measurable disease
RECIST 1.1 was used to define objective tumor response. A complete response is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. A partial response is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. There can be no unequivocal progression of non-target lesions and no new lesions. Complete and partial responses are included in the objective tumor response rate. Confirmation of response was not required.
Outcome measures
| Measure |
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
n=85 Participants
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
n=89 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
n=85 Participants
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
|---|---|---|---|
|
The Proportion of Patients With Measurable Disease Who Have Confirmed Objective Tumor Responses by Treatment.
|
45 Participants
|
53 Participants
|
47 Participants
|
Adverse Events
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
Serious events: 48 serious events
Other events: 112 other events
Deaths: 0 deaths
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
Serious events: 57 serious events
Other events: 113 other events
Deaths: 0 deaths
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
Serious events: 53 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
n=112 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
n=113 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
n=114 participants at risk
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Platelets
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Left Venticular Diastolic Dysfunction
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Inr
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fever
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Weight Loss
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fatigue
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Death No Ctcae Term - Death Nos
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Death No Ctcae Term - Multi-Organ Failure
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Perforation, Gi - Colon
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Ileus
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dysphagia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Leak, Gi - Small Bowel
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Vasovagal Episode
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Hypertension
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis - Abdomen
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dehydration
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Nausea
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hematoma
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage/Pulmonary - Bronchus
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Hepatobiliary disorders
Cholecystitis
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bone
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Febrile Neutropenia
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Blood
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary)
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Wound
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Foreign Body
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Catheter-Related
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Limb
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Proteinuria
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Creatinine
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Bilirubin
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Syncope
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neurology - Other
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Seizure
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Cns Ischemia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Confusion
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Dizziness
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy-Motor
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Chest /Thorax Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Head/Headache
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Back
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Joint
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Gallbladder
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Abdominal Pain Nos
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Muscle
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Other adverse events
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevacizumab)
n=112 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
Arm II (Paclitaxel, Carboplatin, Temsirolimus)
n=113 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
|
Arm III (Ixabepilone, Carboplatin, Bevacizumab)
n=114 participants at risk
Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Gait/Walking
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Somnolence
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Cognitive Disturbance
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Confusion
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Memory Impairment
|
5.4%
6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.0%
9/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Dizziness
|
27.7%
31/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
10.6%
12/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
23.7%
27/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mood Alteration - Depression
|
17.0%
19/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
15.0%
17/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
16.7%
19/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
14.3%
16/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
15.0%
17/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
16.7%
19/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mood Alteration - Agitation
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Tremor
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Speech Impairment
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Seizure
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy-Motor
|
9.8%
11/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Ocular/Visual - Other
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Uveitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Proptosis/Enophthalmos
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Watery Eye
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Glaucoma
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Dry Eye
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Ocular Surface Disease
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Cataract
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Photophobia
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Flashing Lights/Floaters
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Diplopia
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Blurred Vision
|
17.0%
19/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.8%
10/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
17.5%
20/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Eyelid Dysfunction
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain - Other
|
8.0%
9/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
10.5%
12/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Urethra
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Pelvis
|
5.4%
6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Breast
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Vagina
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Chest /Thorax Nos
|
8.0%
9/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
12.3%
14/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Chest Wall
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
7.1%
8/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.2%
7/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Pleura
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Eye
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Head/Headache
|
45.5%
51/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
18.6%
21/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
34.2%
39/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Neck
|
5.4%
6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Extremity-Limb
|
34.8%
39/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
20.4%
23/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
25.4%
29/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy,cranial - Cn Viii Hearing/Balance
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Buttock
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy,cranial - Cn I Smell
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy-Sensory
|
70.5%
79/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
68.1%
77/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
60.5%
69/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Back
|
24.1%
27/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
16.8%
19/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
17.5%
20/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Joint
|
46.4%
52/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
26.5%
30/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
36.8%
42/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Bone
|
7.1%
8/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
10.5%
12/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Kidney
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Bladder
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Pain Nos
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Stomach
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Rectum
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Oral Cavity
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.1%
8/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Anus
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Neuralgia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Sinus
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.1%
7/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
12.5%
14/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
10.5%
12/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Urinary Retention
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Obstruction, Gu - Urethra
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Edema, Larynx
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Incontinence, Urinary
|
7.1%
8/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.1%
8/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.1%
7/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Renal Failure
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Urinary Frequency
|
18.8%
21/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
14.2%
16/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
12.3%
14/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
8.0%
9/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.1%
7/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Libido
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
48/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
32.7%
37/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
25.4%
29/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dlco
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
43.8%
49/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
34.5%
39/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
49.1%
56/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Leak, Gu - Urethra
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Cystitis
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Esophagus
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Abdominal Pain Nos
|
33.0%
37/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
35.4%
40/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
35.1%
40/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Scalp
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Oral - Gums
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Skin
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Lip
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Middle Ear
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: External Ear
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Cardiac/ Heart
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Tumor
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Muscle
|
26.8%
30/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
32.7%
37/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
21.9%
25/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function: Other
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Vaginitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Vaginal Stenosis
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Vaginal Mucositis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.4%
6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Syndromes - Other
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Cytokine Release Syndrome
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Flu-Like Syndrome
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Irregular Menses
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Vascular - Other
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Neutrophils
|
94.6%
106/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
93.8%
106/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
89.5%
102/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Platelets
|
77.7%
87/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
85.0%
96/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
88.6%
101/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Leukocytes
|
98.2%
110/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
97.3%
110/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
92.1%
105/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.0%
9/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.1%
8/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Hemoglobin
|
93.8%
105/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
98.2%
111/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
96.5%
110/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Palpitations
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Vasovagal Episode
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Ventricular Arrhythmia - Arrhythmia Nos
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Ventricular Arrhythmia - Pvcs
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Hypertension
|
45.5%
51/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
15.9%
18/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
43.9%
50/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Valvular Heart Disease
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Left Venticular Diastolic Dysfunction
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Hypotension
|
5.4%
6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Cardipulmonary Arrest
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Inr
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.0%
9/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Coagulopathy - Other
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Ptt
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Constitutional Symptoms - Other
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Sweating
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Weight Gain
|
14.3%
16/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.2%
7/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Patient Odor
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fever
|
15.2%
17/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
12.4%
14/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
12.3%
14/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Weight Loss
|
21.4%
24/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
25.7%
29/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
27.2%
31/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Hypothermia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Rigors/Chills
|
5.4%
6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.1%
7/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.8%
10/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.8%
10/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Phlebitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
5.4%
6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
11.4%
13/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fatigue
|
89.3%
100/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
79.6%
90/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
86.0%
98/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Insomnia
|
21.4%
24/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
27.4%
31/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
19.3%
22/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Immune system disorders
Rhinitis
|
21.4%
24/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
13.3%
15/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
17.5%
20/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Ear and labyrinth disorders
Otitis Middle Ear
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
5.4%
6/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Ear and labyrinth disorders
Tinnitus
|
11.6%
13/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
10.5%
12/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Ear and labyrinth disorders
Hearing (Monitoring Program)
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
78.6%
88/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
71.7%
81/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
72.8%
83/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Esophagitis
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Bruising
|
8.9%
10/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.0%
9/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.9%
9/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.8%
10/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.1%
18/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
46.0%
52/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
16.7%
19/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.8%
10/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Atrophy, Skin
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.7%
12/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
15.9%
18/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
10.5%
12/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Flushing
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
9.7%
11/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.1%
8/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Heartburn
|
10.7%
12/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.2%
7/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Endocrine disorders
Hot Flashes
|
10.7%
12/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.0%
9/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Endocrine disorders
Endocrine - Other
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Salivary Gland Changes
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
8.9%
10/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
15.0%
17/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Taste Alteration
|
11.6%
13/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
22.1%
25/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
14.9%
17/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Incontinence, Anal
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
12.5%
14/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
23.0%
26/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
12.3%
14/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Fistula, Gi - Oral Cavity
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Esophagus
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dental: Teeth
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Leak, Gi - Leak Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.9%
9/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Distention
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Stomach
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Anorexia
|
47.3%
53/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
40.7%
46/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
43.9%
50/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dehydration
|
11.6%
13/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.8%
10/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
14.9%
17/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Constipation
|
58.9%
66/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
51.3%
58/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
57.9%
66/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Nausea
|
69.6%
78/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
64.6%
73/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
71.1%
81/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
49.1%
55/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
41.6%
47/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
48.2%
55/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
9.8%
11/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.1%
8/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
12.3%
14/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage/Pulmonary - Bronchopulmonary Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage/Pulmonary - Respiratory Tract Nos
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Varices (Rectal)
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
30.4%
34/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
21.2%
24/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
28.1%
32/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hematoma
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Anus
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Uterus
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Ureter
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Lower Gi Nos
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Petechiae
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Hepatobiliary disorders
Cholecystitis
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Hepatobiliary disorders
Liver Dysfunction
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Wound
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Dental-Tooth
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.9%
9/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
13.4%
15/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
23.9%
27/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.1%
7/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Vomiting
|
41.1%
46/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
31.9%
36/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
44.7%
51/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Peritoneal Cavity
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Heart
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Febrile Neutropenia
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Sinus
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
17.9%
20/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
9.7%
11/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
14.9%
17/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Blood
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Infection - Other
|
7.1%
8/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Muscle
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Vulva
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Abdomen Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Eye Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Lymphatic
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Catheter-Related
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Vagina
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Sinus
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Nerve-Peripheral
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Ungual (Nails)
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
1.8%
2/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Catheter-Related
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Viscera
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Limb
|
22.3%
25/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
40.7%
46/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
24.6%
28/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
5.3%
6/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.2%
7/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
31.0%
35/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Proteinuria
|
14.3%
16/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
13.2%
15/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Creatinine
|
18.8%
21/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
18.6%
21/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
18.4%
21/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.5%
23/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
27.4%
31/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
24.6%
28/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Alt
|
18.8%
21/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
18.6%
21/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
14.0%
16/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
17.0%
19/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
22.1%
25/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
17.5%
20/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Bilirubin
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
6.2%
7/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.9%
9/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.0%
8/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.6%
13/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
17.7%
20/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.9%
9/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyponatremia
|
24.1%
27/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
21.2%
24/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
29.8%
34/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Ast
|
17.9%
20/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
23.0%
26/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
17.5%
20/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Gfr
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
27.4%
31/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
4.4%
5/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Cpk
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Extremity-Upper (Function)
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.8%
21/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
24.8%
28/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
26.3%
30/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.7%
12/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
7.1%
8/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
8.8%
10/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
39.3%
44/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
42.5%
48/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
33.3%
38/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
24.1%
27/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
38.1%
43/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
26.3%
30/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.2%
45/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
31.9%
36/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
28.9%
33/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Seroma
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
6.2%
7/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.6%
3/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
11.6%
13/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
9.7%
11/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
10.5%
12/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Trunk
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
3.6%
4/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Syncope
|
4.5%
5/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
2.7%
3/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
3.5%
4/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Involuntary Movement
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Hydrocephalus
|
0.89%
1/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neurology - Other
|
2.7%
3/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
1.8%
2/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mental Status
|
0.00%
0/112 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.00%
0/113 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
0.88%
1/114 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60