Trial Outcomes & Findings for Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma (NCT NCT00918333)
NCT ID: NCT00918333
Last Updated: 2020-03-10
Results Overview
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
124 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
Phase I (Panobinostat + Everolimus)
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Panobinostat + Everolimus)
Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
98
|
|
Overall Study
COMPLETED
|
23
|
93
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Phase I (Panobinostat + Everolimus)
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Panobinostat + Everolimus)
Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Drug not taken per protocol
|
1
|
0
|
|
Overall Study
Inadequate amount of drugs provided
|
1
|
4
|
|
Overall Study
Ineligible
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Phase I (Panobinostat + Everolimus)
n=23 Participants
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Panobinostat + Everolimus)
n=93 Participants
Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
n=5 Participants
|
59.0 years
n=7 Participants
|
59.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.
Outcome measures
| Measure |
Phase I (Panobinostat + Everolimus)
n=23 Participants
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 20 mg LBH589)
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 coursesPopulation: Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
For myeloma, a complete response(CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h), or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%) noted as the objective status. For lymphoma, a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Outcome measures
| Measure |
Phase I (Panobinostat + Everolimus)
n=41 Participants
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 20 mg LBH589)
n=14 Participants
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
n=20 Participants
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
n=18 Participants
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Response Rate (Phase II)
|
39 percentage of patients
Interval 23.0 to 53.0
|
7 percentage of patients
Interval 0.0 to 34.0
|
20 percentage of patients
Interval 2.0 to 31.0
|
0 percentage of patients
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to 2 years post-treatmentPopulation: Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase I (Panobinostat + Everolimus)
n=41 Participants
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 20 mg LBH589)
n=14 Participants
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
n=20 Participants
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
n=18 Participants
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Survival Time (Phase II)
|
17.1 months
Interval 7.0 to
The upper bound of the 95% confidence interval has not yet been reached.
|
16.6 months
Interval 9.7 to
The upper bound of the 95% confidence interval has not yet been reached.
|
35.4 months
Interval 11.5 to
The upper bound of the 95% confidence interval has not yet been reached.
|
21.7 months
Interval 12.1 to 47.6
|
SECONDARY outcome
Timeframe: Time from registration to progression or death due to any cause, assessed up to 2 years post-treatmentPopulation: Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase I (Panobinostat + Everolimus)
n=41 Participants
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 20 mg LBH589)
n=14 Participants
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
n=20 Participants
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
n=18 Participants
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Progression-free Survival (Phase II)
|
3.7 months
Interval 2.1 to 8.3
|
2.3 months
Interval 1.0 to
The upper bound of the 95% confidence interval has not yet been reached.
|
4.2 months
Interval 3.0 to 9.6
|
4.3 months
Interval 3.9 to 5.8
|
SECONDARY outcome
Timeframe: The time from the date at which the patient's objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatmentPopulation: Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.
Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase I (Panobinostat + Everolimus)
n=16 Participants
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 20 mg LBH589)
n=1 Participants
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
n=4 Participants
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Duration of Response (Phase II)
|
9.1 months
Interval 6.5 to 33.5
|
NA months
The median and upper bound of the 95% confidence interval have not yet been reached.
|
12.9 months
Interval 4.2 to 30.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 5 and 19 of the first course and then day 1 of each subsequent courses (courses 2-4) prior to the daily dose and 1 and 2 hours after each doseChanges in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 12 coursesChanges in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.
Outcome measures
Outcome data not reported
Adverse Events
Phase I (Panobinostat + Everolimus)
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Phase II (Panobinostat + Everolimus)
Serious events: 25 serious events
Other events: 92 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I (Panobinostat + Everolimus)
n=23 participants at risk
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Panobinostat + Everolimus)
n=93 participants at risk
Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Ileal hemorrhage
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Fatigue
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Ill-defined disorder
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Sepsis
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Skin infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Creatinine increased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Leukocyte count decreased
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Neutrophil count decreased
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Platelet count decreased
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.4%
5/93 • Number of events 6 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Renal and urinary disorders
Renal failure
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
Other adverse events
| Measure |
Phase I (Panobinostat + Everolimus)
n=23 participants at risk
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II (Panobinostat + Everolimus)
n=93 participants at risk
Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
95.7%
22/23 • Number of events 167 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
97.8%
91/93 • Number of events 349 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Eye disorders
Keratitis
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Diarrhea
|
65.2%
15/23 • Number of events 76 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
58.1%
54/93 • Number of events 204 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
69.6%
16/23 • Number of events 71 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
55.9%
52/93 • Number of events 101 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Gingival pain
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Nausea
|
43.5%
10/23 • Number of events 28 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
44.1%
41/93 • Number of events 112 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • Number of events 5 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
32.3%
30/93 • Number of events 47 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Chills
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Edema limbs
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Fatigue
|
91.3%
21/23 • Number of events 126 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
89.2%
83/93 • Number of events 346 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Fever
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Localized edema
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Pain
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Bone infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Catheter related infection
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Lip infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Otitis externa
|
4.3%
1/23 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Pneumonia
|
17.4%
4/23 • Number of events 6 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Sepsis
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Sinusitis
|
8.7%
2/23 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Skin infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
6.5%
6/93 • Number of events 10 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
4.3%
4/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Creatinine increased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
8.6%
8/93 • Number of events 9 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
INR increased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Leukocyte count decreased
|
87.0%
20/23 • Number of events 86 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
74.2%
69/93 • Number of events 156 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Lymphocyte count decreased
|
43.5%
10/23 • Number of events 16 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
29.0%
27/93 • Number of events 63 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Neutrophil count decreased
|
82.6%
19/23 • Number of events 85 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
71.0%
66/93 • Number of events 159 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Platelet count decreased
|
95.7%
22/23 • Number of events 117 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
90.3%
84/93 • Number of events 307 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Serum cholesterol increased
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 5 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Weight loss
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Anorexia
|
8.7%
2/23 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
6.5%
6/93 • Number of events 8 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
17.4%
4/23 • Number of events 9 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
7.5%
7/93 • Number of events 10 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
13.0%
3/23 • Number of events 6 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
22.6%
21/93 • Number of events 40 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
26.1%
6/23 • Number of events 17 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
8.6%
8/93 • Number of events 20 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 2 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 5 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Ischemia cerebrovascular
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Memory impairment
|
4.3%
1/23 • Number of events 9 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Taste alteration
|
21.7%
5/23 • Number of events 12 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
4.3%
4/93 • Number of events 14 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Tremor
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Psychiatric disorders
Confusion
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 4 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Renal and urinary disorders
Cystitis
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Renal and urinary disorders
Urinary incontinence
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/93 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
4.3%
4/93 • Number of events 5 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.7%
2/23 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
4.3%
4/93 • Number of events 6 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
1.1%
1/93 • Number of events 1 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
34.8%
8/23 • Number of events 26 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
30.1%
28/93 • Number of events 49 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
3.2%
3/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/23 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
2.2%
2/93 • Number of events 3 • Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place