Trial Outcomes & Findings for CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer (NCT NCT00112840)
NCT ID: NCT00112840
Last Updated: 2022-02-01
Results Overview
For this protocol, dose limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment in the first four weeks of combination therapy, and meeting the following criteria: * Grade 4 Absolute neutrophil count (ANC) for 5+ days. * Grade 4 anemia or thrombocytopenia of any duration. * Serum Creatinine 2 times baseline or 2x upper limit of normal if baseline levels not normal. * Any other non-hematologic grade 3 or higher as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, except fatigue and grade 3 Hypertension that is will be controlled with oral medication. * Grade 3 triglycerides will be a DLT for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy. The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose where 1 or 0 out of 6 patients experience DLT with the next higher dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles.
Results posted on
2022-02-01
Participant Flow
From 5/11/2005 to 7/19/2006, 14 participants were registered to the Phase I portion of the study (8 at Dose Level 1 and 6 at Dose Level 2). Phase II opened 02/09/2007 at Dose Level 2 and registered 46 patients before closing with full accrual on 6/15/2010.
In Phase I, Dose Level 2, 2 subjects were unevaluable because they were removed from the study before completing cycle 1 of treatment for reasons other than toxicity. In Phase II, 5/46 patients were ineligible and one patient cancelled.
Participant milestones
| Measure |
Phase I, Dose Level 1
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I, Dose Level 2
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1= 10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
46
|
|
Overall Study
COMPLETED
|
6
|
6
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
6
|
Reasons for withdrawal
| Measure |
Phase I, Dose Level 1
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I, Dose Level 2
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1= 10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
5
|
Baseline Characteristics
CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer
Baseline characteristics by cohort
| Measure |
Phase I, Dose Level 1
n=8 Participants
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I, Dose Level 2
n=6 Participants
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
n=46 Participants
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=39 Participants
|
66 years
n=41 Participants
|
62 years
n=35 Participants
|
62.5 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
47 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=39 Participants
|
6 participants
n=41 Participants
|
46 participants
n=35 Participants
|
60 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles.For this protocol, dose limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment in the first four weeks of combination therapy, and meeting the following criteria: * Grade 4 Absolute neutrophil count (ANC) for 5+ days. * Grade 4 anemia or thrombocytopenia of any duration. * Serum Creatinine 2 times baseline or 2x upper limit of normal if baseline levels not normal. * Any other non-hematologic grade 3 or higher as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, except fatigue and grade 3 Hypertension that is will be controlled with oral medication. * Grade 3 triglycerides will be a DLT for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy. The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose where 1 or 0 out of 6 patients experience DLT with the next higher dose.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=6 Participants
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
Phase 1 , Dose Level 2
n=6 Participants
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Dose-limiting Toxicity (DLT) (Phase I)
|
1 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: 6 months after study entryPopulation: Only Phase II participants were analyzed for this endpoint. Forty participants from Phase II were evaluable for this endpoint.
Determination of progression will be made according to Response Evaluation Criteria in Solid Tumors (RECIST). A progression (PD) is defined as having at least a 20% increase in the sum of the longest dimension of target lesions taking as reference the smallest sum of the largest dimension recorded at baseline.The proportion of progression-free patients will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the success proportion will be calculated. All patients meeting the eligibility criteria who have signed a consent form and begun treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.
Outcome measures
| Measure |
Phase I, Dose Level 1
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
Phase 1 , Dose Level 2
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
n=40 Participants
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Proportion of Progression-free Patients at 6 Months (Phase II)
|
—
|
—
|
40 percentage of participants
Interval 25.0 to 55.0
|
SECONDARY outcome
Timeframe: Up to 3 years from study registrationPopulation: All eligible Phase II patients were used to assess this endpoint.
The number of participants with clinical tumor response to treatment will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=40 Participants
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
Phase 1 , Dose Level 2
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Clinical Best Response Rate of CCI-779 and Bevacizumab in Patients With Metastatic Renal Cell (Phase II)
Partial Response (PR)
|
20 percentage of participants
|
—
|
—
|
|
Clinical Best Response Rate of CCI-779 and Bevacizumab in Patients With Metastatic Renal Cell (Phase II)
Complete Response (CR)
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years from study registrationPopulation: All eligible participants in Phase II were used for this endpoint.
The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=40 Participants
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
Phase 1 , Dose Level 2
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Time to Progression (Phase II)
|
7.6 months
Interval 4.0 to 7.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years from study registrationPopulation: All eligible participants were used for this endpoint.
The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=6 Participants
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
Phase 1 , Dose Level 2
n=6 Participants
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
n=40 Participants
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Overall Survival (Phase I and II)
|
24.4 months
Interval 4.6 to
Upper 95% confidence limit wasn't calculable due to an insufficient number of events
|
17 months
Interval 4.4 to 54.8
|
20.6 months
Interval 11.5 to 23.7
|
Adverse Events
Phase I, Dose Level 1
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase I, Dose Level 2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II
Serious events: 12 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I, Dose Level 1
n=8 participants at risk
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I, Dose Level 2
n=6 participants at risk
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
n=45 participants at risk
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Psychiatric disorders
Confusion
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Renal and urinary disorders
Renal failure
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Peritoneal hemorrhage
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Chest pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Injection site reaction
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Creatinine increased
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
INR increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
2/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
Other adverse events
| Measure |
Phase I, Dose Level 1
n=8 participants at risk
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I, Dose Level 2
n=6 participants at risk
Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
n=45 participants at risk
Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
87.5%
7/8 • Number of events 23
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
100.0%
6/6 • Number of events 25
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
88.9%
40/45 • Number of events 161
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 4
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Anal exam abnormal
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Number of events 13
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
83.3%
5/6 • Number of events 13
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
40.0%
18/45 • Number of events 54
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
15.6%
7/45 • Number of events 9
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Gingival pain
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
2/8 • Number of events 10
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
66.7%
4/6 • Number of events 9
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
57.8%
26/45 • Number of events 73
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
50.0%
3/6 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
22.2%
10/45 • Number of events 21
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 4
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Proctitis
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Proctoscopy abnormal
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
50.0%
3/6 • Number of events 4
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Chest pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Edema limbs
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
11.1%
5/45 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Facial pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
83.3%
5/6 • Number of events 23
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
77.8%
35/45 • Number of events 171
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Fever
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Localized edema
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
11.1%
5/45 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Infection
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Otitis media
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
15.6%
7/45 • Number of events 16
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
22.2%
10/45 • Number of events 24
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Amylase increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
24.4%
11/45 • Number of events 25
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Creatinine increased
|
62.5%
5/8 • Number of events 22
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
50.0%
3/6 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
57.8%
26/45 • Number of events 145
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
INR increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 10
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Lipase increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
2/8 • Number of events 9
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Neutrophil count decreased
|
37.5%
3/8 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
50.0%
3/6 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Platelet count decreased
|
37.5%
3/8 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
66.7%
4/6 • Number of events 16
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
42.2%
19/45 • Number of events 57
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Serum cholesterol increased
|
37.5%
3/8 • Number of events 25
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
100.0%
6/6 • Number of events 20
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
68.9%
31/45 • Number of events 115
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Weight gain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Investigations
Weight loss
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 9
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
22.2%
10/45 • Number of events 29
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
2/8 • Number of events 4
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
83.3%
5/6 • Number of events 23
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
40.0%
18/45 • Number of events 47
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
31.1%
14/45 • Number of events 56
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
11.1%
5/45 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 18
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
25.0%
2/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
66.7%
4/6 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
24.4%
11/45 • Number of events 20
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
25.0%
2/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
37.5%
3/8 • Number of events 8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
22.2%
10/45 • Number of events 14
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 13
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
37.5%
3/8 • Number of events 14
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
50.0%
3/6 • Number of events 16
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
73.3%
33/45 • Number of events 132
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 10
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
11.1%
5/45 • Number of events 15
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
13.3%
6/45 • Number of events 16
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 4
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
25.0%
2/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 4
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
11.1%
5/45 • Number of events 22
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Renal and urinary disorders
Proteinuria
|
62.5%
5/8 • Number of events 20
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 4
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
53.3%
24/45 • Number of events 84
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
25.0%
2/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 10
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
15.6%
7/45 • Number of events 9
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
17.8%
8/45 • Number of events 13
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8 • Number of events 10
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
50.0%
3/6 • Number of events 4
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
48.9%
22/45 • Number of events 86
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
25.0%
2/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
11.1%
5/45 • Number of events 12
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
13.3%
6/45 • Number of events 9
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 10
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
12.5%
1/8 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
8.9%
4/45 • Number of events 11
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
6.7%
3/45 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
15.6%
7/45 • Number of events 9
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
37.5%
3/8 • Number of events 22
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
50.0%
3/6 • Number of events 8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
28.9%
13/45 • Number of events 43
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
16.7%
1/6 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 2
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 5
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Vascular disorders
Flushing
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Vascular disorders
Hematoma
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
4.4%
2/45 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Vascular disorders
Hemorrhage
|
12.5%
1/8 • Number of events 7
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/45
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Vascular disorders
Hypertension
|
37.5%
3/8 • Number of events 9
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
2/6 • Number of events 3
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
33.3%
15/45 • Number of events 75
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
0.00%
0/6
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
2.2%
1/45 • Number of events 1
All patients that began study treatment and were assessed for adverse events are included in this report. Of the 46 patients that registered, one patient canceled prior to treatment and was not assessed for adverse events. Therefore, 45 patients are used in this report.
|
Additional Information
Jaime Merchan, M.D.
University of Miami - Sylvester Comprehensive Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60