Trial Outcomes & Findings for Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme (NCT NCT00892177)
NCT ID: NCT00892177
Last Updated: 2019-10-21
Results Overview
The Maximum Tolerated Dose (MTD) will be based on the assessment of dose-limiting toxicities (DLT) during the first 4 weeks of treatment only (i.e., following the first 2 treatment cycles), and will be defined as the dose at which fewer than one-third of patients experience a DLT to study treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with the next higher dose having at least 2 out of 3 or 2 out of 6 patients encountering DLT.\> Three patients will be treated at each dose level, and can be enrolled simultaneously. If one DLT is encountered, an additional 3 patients will be added to that dose level. If at any point two DLTs are encountered within a given dose level, then the MTD has been exceeded and if only three patients have been treated at the next lower dose three more patients are treated at the next lower dose. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
144 participants
Primary outcome timeframe
14 days
Results posted on
2019-10-21
Participant Flow
Participant milestones
| Measure |
Phase I: Dose Level 0
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm A (Bevacizumab + Dasatinib)
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm B (Bevacizumab + Placebo)
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Phase I: Dose Level 0
STARTED
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Dose Level 0
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Dose Level 0
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Dose Level 1
STARTED
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Phase I: Dose Level 1
COMPLETED
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Phase I: Dose Level 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Dose Level 2
STARTED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Phase I: Dose Level 2
COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Phase I: Dose Level 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Dose Level 3
STARTED
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Phase I: Dose Level 3
COMPLETED
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Phase I: Dose Level 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
0
|
0
|
88
|
40
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
0
|
83
|
38
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
5
|
2
|
Reasons for withdrawal
| Measure |
Phase I: Dose Level 0
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm A (Bevacizumab + Dasatinib)
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm B (Bevacizumab + Placebo)
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Phase II
Ineligible
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Phase II
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
4
|
1
|
Baseline Characteristics
Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Phase I
n=16 Participants
Patients receive (either: 5 or 10 mg/kg) bevacizumab IV over 90 minutes on Day 1 and oral dasatinib (either: 50, 70, or 100 mg) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm A (Bevacizumab + Dasatinib)
n=83 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm B (Bevacizumab + Placebo)
n=38 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.5 years
n=99 Participants
|
58 years
n=107 Participants
|
56.5 years
n=206 Participants
|
57 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
137 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Adverse event information is available for 4 patients on study 1 dose level 1 (with 1 being a MTD replacement due to disease progression prior to completing cycles 1 and 2).
The Maximum Tolerated Dose (MTD) will be based on the assessment of dose-limiting toxicities (DLT) during the first 4 weeks of treatment only (i.e., following the first 2 treatment cycles), and will be defined as the dose at which fewer than one-third of patients experience a DLT to study treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with the next higher dose having at least 2 out of 3 or 2 out of 6 patients encountering DLT.\> Three patients will be treated at each dose level, and can be enrolled simultaneously. If one DLT is encountered, an additional 3 patients will be added to that dose level. If at any point two DLTs are encountered within a given dose level, then the MTD has been exceeded and if only three patients have been treated at the next lower dose three more patients are treated at the next lower dose. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.
Outcome measures
| Measure |
Phase I : Dose Level 0
n=3 Participants
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 1
n=4 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 2
n=3 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 3 Cohort 1
n=3 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3 Cohort 2
n=3 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I)
|
0 participants who developed DLTs
|
0 participants who developed DLTs
|
0 participants who developed DLTs
|
0 participants who developed DLTs
|
1 participants who developed DLTs
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All patients that received treatment and were eligible for assessment were included in this analysis.
The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation (PFS6). All eligible consented patients that received treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS6 will be estimated as the number of evaluable patients progression free and still alive at 6 months divided by the total number of evaluable patients. The confidence interval will be calculated according to the Clopper-Pearson Method.
Outcome measures
| Measure |
Phase I : Dose Level 0
n=83 Participants
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 1
n=38 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 3 Cohort 1
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3 Cohort 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Progression-free Survival at 6 Months (PFS6) (Phase II)
|
0.29 proportion of participants
Interval 0.19 to 0.39
|
0.18 proportion of participants
Interval 0.08 to 0.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All Phase II patients treated and evaluated for adverse events are included in this Phase II endpoint analysis.
Adverse events were collected systematically at the end of each cycle and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Events are scored as: 1="Mild symptoms", 2= "Moderate", 3="Severe", 4="Life-threatening", and 5="Death". The number of patients reporting a grade 3 or higher event regardless of attribution are summarized here. A complete list of all adverse events reported during treatment can be found in the Adverse Events Section.
Outcome measures
| Measure |
Phase I : Dose Level 0
n=83 Participants
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 1
n=38 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 3 Cohort 1
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3 Cohort 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II)
Grade 3 Adverse Event
|
42 participants
|
23 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II)
Grade 4 Adverse Event
|
8 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II)
Grade 5 Adverse Event
|
5 participants
|
3 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All eligible Phase II patients are included in this Phase II endpoint analysis.
Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both arms of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.
Outcome measures
| Measure |
Phase I : Dose Level 0
n=83 Participants
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 1
n=38 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 3 Cohort 1
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3 Cohort 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Survival (Phase II)
|
7.3 months
Interval 6.2 to 8.7
|
7.9 months
Interval 6.6 to 11.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All eligible Phase II patients are included in this Phase II endpoint analysis.
Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. Patients who experience major treatment violations will be censored for progression on the date the treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase I : Dose Level 0
n=83 Participants
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 1
n=38 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 3 Cohort 1
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3 Cohort 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Time-to-disease Progression (Phase II)
|
3.3 months
Interval 2.79 to 4.6
|
3.5 months
Interval 2.83 to 4.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to cycle 10 (20 weeks).Population: All Phase II patients that began treatment and submitted at least one FACT-Br questionnaire were included in this analysis.
FACT-Br questionnaires were used to assess QOL at every other cycle of treatment (prior to cycles 3, 5, 7, etc.). FACT-Br includes 50 questions used to assess patients' self-assessment in 4 broad categories: Physical, Social/Family, Emotional, and Function Well-being. Scores range from 0="Not at all", 1="A little bit", 2="Somewhat", 3="Quite a bit", 4="Very Much". Higher scores can be interpreted as having higher quality of life. The scores for all 50 questions were summed to give a total score per patient per cycle. Therefore the possible range is from 0 to 200. Below is the reported mean and standard deviation for patients at baseline and during cycles 2, 4, 6, 8, and 10.
Outcome measures
| Measure |
Phase I : Dose Level 0
n=77 Participants
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 1
n=34 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 3 Cohort 1
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3 Cohort 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)
Cycle 0
|
139.5 units on a scale
Standard Deviation 26.2
|
138.3 units on a scale
Standard Deviation 22.4
|
—
|
—
|
—
|
|
Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)
Cycle 2
|
131.2 units on a scale
Standard Deviation 27.9
|
133.5 units on a scale
Standard Deviation 23.5
|
—
|
—
|
—
|
|
Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)
Cycle 4
|
137.6 units on a scale
Standard Deviation 30.1
|
137.4 units on a scale
Standard Deviation 23.1
|
—
|
—
|
—
|
|
Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)
Cycle 6
|
140.1 units on a scale
Standard Deviation 29.0
|
137.7 units on a scale
Standard Deviation 25.7
|
—
|
—
|
—
|
|
Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)
Cycle 8
|
142.3 units on a scale
Standard Deviation 30.2
|
142.8 units on a scale
Standard Deviation 31.1
|
—
|
—
|
—
|
|
Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)
Cycle10
|
142.1 units on a scale
Standard Deviation 34.9
|
149.3 units on a scale
Standard Deviation 34.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All eligible Phase II patients are included in this Phase II endpoint analysis.
Objective response to treatment will be determined by the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The percentage of patients in each response category will be summarized, 95% confidence intervals calculated, and rates between the 2 arms will be compared using a Fisher's Exact test. For bi-dimensionally measurable disease, CR: total disappearance of all tumor and that patients be on no corticosteroids or on only adrenal replacement maintenance; PR: ≥ 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions, and stable or decreasing steroid dosing; PD: \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions; REGR: unequivocal reduction in extent of contrast-enhancement, or a decrease in mass effect, no new lesions (for evaluable disease); SD: failure to qualify for CR, PR,REGR or PD.
Outcome measures
| Measure |
Phase I : Dose Level 0
n=83 Participants
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 1
n=38 Participants
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I : Dose Level 3 Cohort 1
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3 Cohort 2
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Objective Response (Phase II)
CR
|
2.4 percentage of participants
Interval 0.5 to 7.4
|
2.6 percentage of participants
Interval 0.0 to 11.8
|
—
|
—
|
—
|
|
Objective Response (Phase II)
PR
|
2.4 percentage of participants
Interval 0.5 to 7.4
|
5.3 percentage of participants
Interval 1.1 to 15.3
|
—
|
—
|
—
|
|
Objective Response (Phase II)
REGR
|
10.8 percentage of participants
Interval 6.3 to 17.9
|
18.4 percentage of participants
Interval 10.1 to 30.9
|
—
|
—
|
—
|
|
Objective Response (Phase II)
SD
|
57.8 percentage of participants
Interval 48.8 to 66.4
|
57.9 percentage of participants
Interval 44.6 to 70.1
|
—
|
—
|
—
|
|
Objective Response (Phase II)
PD
|
12.0 percentage of participants
Interval 7.2 to 19.3
|
5.3 percentage of participants
Interval 1.1 to 15.3
|
—
|
—
|
—
|
|
Objective Response (Phase II)
Missing/Unknown
|
14.5 percentage of participants
Interval 9.1 to 22.0
|
10.5 percentage of participants
Interval 4.4 to 21.9
|
—
|
—
|
—
|
Adverse Events
Phase I: Dose Level 0
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: Dose Level 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I: Dose Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: Dose Level 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II: Arm A (Bevacizumab + Dasatinib)
Serious events: 32 serious events
Other events: 83 other events
Deaths: 0 deaths
Phase II: Arm B (Bevacizumab + Placebo)
Serious events: 18 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Dose Level 0
n=3 participants at risk
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
n=4 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
n=3 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3
n=6 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm A (Bevacizumab + Dasatinib)
n=84 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm B (Bevacizumab + Placebo)
n=39 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Death
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.7%
3/39 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.7%
3/39 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Gait abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Sudden death
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 21 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Injury, poisoning and procedural complications
Intraoperative complications
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Bilirubin increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
4.8%
4/84 • Number of events 5 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
10.3%
4/39 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.7%
3/39 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
Other adverse events
| Measure |
Phase I: Dose Level 0
n=3 participants at risk
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
n=4 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
n=3 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 3
n=6 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm A (Bevacizumab + Dasatinib)
n=84 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Phase II: Arm B (Bevacizumab + Placebo)
n=39 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
6.0%
5/84 • Number of events 8 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
9.5%
8/84 • Number of events 13 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
10.3%
4/39 • Number of events 9 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
2/6 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
36.9%
31/84 • Number of events 82 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
28.2%
11/39 • Number of events 37 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
3/3 • Number of events 28 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
50.0%
2/4 • Number of events 24 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
66.7%
2/3 • Number of events 22 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
83.3%
5/6 • Number of events 20 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
79.8%
67/84 • Number of events 432 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
35.9%
14/39 • Number of events 38 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Ear and labyrinth disorders
Hearing test abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Eye disorders
Eye disorder
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
11.9%
10/84 • Number of events 17 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
17.9%
7/39 • Number of events 14 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.1%
6/84 • Number of events 8 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
1/3 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
50.0%
3/6 • Number of events 13 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
59.5%
50/84 • Number of events 186 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
30.8%
12/39 • Number of events 51 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 9 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
1/3 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
13.1%
11/84 • Number of events 17 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
20.2%
17/84 • Number of events 35 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
10.3%
4/39 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 50 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
100.0%
4/4 • Number of events 37 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
100.0%
3/3 • Number of events 29 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
100.0%
6/6 • Number of events 57 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
86.9%
73/84 • Number of events 478 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
89.7%
35/39 • Number of events 241 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
19.0%
16/84 • Number of events 18 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Gait abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Abdominal infection
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Bone infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Joint infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
4.8%
4/84 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
4.8%
4/84 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
6.0%
5/84 • Number of events 10 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
4.8%
4/84 • Number of events 11 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Blood gonadotrophin abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Leukocyte count decreased
|
66.7%
2/3 • Number of events 14 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
34.5%
29/84 • Number of events 97 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
15.4%
6/39 • Number of events 13 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
2/6 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
15.5%
13/84 • Number of events 35 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
17.9%
7/39 • Number of events 19 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 23 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
14/84 • Number of events 51 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 16 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
66.7%
2/3 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
50.0%
3/6 • Number of events 5 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
56.0%
47/84 • Number of events 180 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
13/39 • Number of events 29 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Weight gain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
32.1%
27/84 • Number of events 182 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
28.2%
11/39 • Number of events 105 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 30 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
40.5%
34/84 • Number of events 114 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
13/39 • Number of events 70 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
4.8%
4/84 • Number of events 8 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
9.5%
8/84 • Number of events 12 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
9.5%
8/84 • Number of events 14 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
33.3%
1/3 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
50.0%
2/4 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
21/84 • Number of events 33 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.7%
3/39 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.1%
6/84 • Number of events 8 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
6.0%
5/84 • Number of events 48 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 7 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 5 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.7%
3/39 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 19 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Central nervous system necrosis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
4.8%
4/84 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.7%
3/39 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
8.3%
7/84 • Number of events 12 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
10.3%
4/39 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
6.0%
5/84 • Number of events 7 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
12.8%
5/39 • Number of events 22 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Nervous system disorders
Taste alteration
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 5 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 5 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
4.8%
4/84 • Number of events 7 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
10.3%
4/39 • Number of events 7 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
6.0%
5/84 • Number of events 14 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.7%
3/39 • Number of events 14 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
6.0%
5/84 • Number of events 5 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 10 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Renal and urinary disorders
Protein urine positive
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 15 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 5 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
3.6%
3/84 • Number of events 5 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
25.0%
1/4 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 7 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
7.1%
6/84 • Number of events 14 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
1/3 • Number of events 10 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.4%
2/84 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 16 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
1.2%
1/84 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
2.6%
1/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/84 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/39 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
50.0%
2/4 • Number of events 11 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
66.7%
2/3 • Number of events 4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
66.7%
4/6 • Number of events 14 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
33.3%
28/84 • Number of events 131 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
46.2%
18/39 • Number of events 92 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/4 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/3 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
0.00%
0/6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
4.8%
4/84 • Number of events 6 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
5.1%
2/39 • Number of events 2 • Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place