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Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT00892177
Recruitment Status : Unknown
Verified May 2017 by Alliance for Clinical Trials in Oncology.
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2009
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Glioblastoma Multiforme
Interventions Biological: bevacizumab
Drug: dasatinib
Other: placebo
Enrollment 144
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I: Dose Level 0 Phase I: Dose Level 1 Phase I: Dose Level 2 Phase I: Dose Level 3 Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Hide Arm/Group Description Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Period Title: Phase I: Dose Level 0
Started 3 0 0 0 0 0
Completed 3 0 0 0 0 0
Not Completed 0 0 0 0 0 0
Period Title: Phase I: Dose Level 1
Started 0 4 0 0 0 0
Completed 0 4 0 0 0 0
Not Completed 0 0 0 0 0 0
Period Title: Phase I: Dose Level 2
Started 0 0 3 0 0 0
Completed 0 0 3 0 0 0
Not Completed 0 0 0 0 0 0
Period Title: Phase I: Dose Level 3
Started 0 0 0 6 0 0
Completed 0 0 0 6 0 0
Not Completed 0 0 0 0 0 0
Period Title: Phase II
Started 0 0 0 0 88 40
Completed 0 0 0 0 83 38
Not Completed 0 0 0 0 5 2
Reason Not Completed
Ineligible             0             0             0             0             1             1
Withdrawal by Subject             0             0             0             0             4             1
Arm/Group Title Phase I Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo) Total
Hide Arm/Group Description Patients receive (either: 5 or 10 mg/kg) bevacizumab IV over 90 minutes on Day 1 and oral dasatinib (either: 50, 70, or 100 mg) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 16 83 38 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 83 participants 38 participants 137 participants
46.5
(28 to 68)
58
(29 to 79)
56.5
(18 to 71)
57
(18 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 83 participants 38 participants 137 participants
Female
3
  18.8%
28
  33.7%
16
  42.1%
47
  34.3%
Male
13
  81.3%
55
  66.3%
22
  57.9%
90
  65.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 83 participants 38 participants 137 participants
16
 100.0%
83
 100.0%
38
 100.0%
137
 100.0%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I)
Hide Description The Maximum Tolerated Dose (MTD) will be based on the assessment of dose-limiting toxicities (DLT) during the first 4 weeks of treatment only (i.e., following the first 2 treatment cycles), and will be defined as the dose at which fewer than one-third of patients experience a DLT to study treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with the next higher dose having at least 2 out of 3 or 2 out of 6 patients encountering DLT. > Three patients will be treated at each dose level, and can be enrolled simultaneously. If one DLT is encountered, an additional 3 patients will be added to that dose level. If at any point two DLTs are encountered within a given dose level, then the MTD has been exceeded and if only three patients have been treated at the next lower dose three more patients are treated at the next lower dose. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse event information is available for 4 patients on study 1 dose level 1 (with 1 being a MTD replacement due to disease progression prior to completing cycles 1 and 2).
Arm/Group Title Phase I : Dose Level 0 Phase I : Dose Level 1 Phase I : Dose Level 2 Phase I : Dose Level 3 Cohort 1 Phase I: Dose Level 3 Cohort 2
Hide Arm/Group Description:
Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 3 4 3 3 3
Measure Type: Number
Unit of Measure: participants who developed DLTs
0 0 0 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase I : Dose Level 0, Phase I : Dose Level 1, Phase I : Dose Level 2, Phase I : Dose Level 3 Cohort 1, Phase I: Dose Level 3 Cohort 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Maximum Tolerated Dose (mg)
Estimated Value 100
Estimation Comments [Not Specified]
2.Primary Outcome
Title Progression-free Survival at 6 Months (PFS6) (Phase II)
Hide Description The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation (PFS6). All eligible consented patients that received treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS6 will be estimated as the number of evaluable patients progression free and still alive at 6 months divided by the total number of evaluable patients. The confidence interval will be calculated according to the Clopper-Pearson Method.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received treatment and were eligible for assessment were included in this analysis.
Arm/Group Title Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Hide Arm/Group Description:
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 83 38
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.29
(0.19 to 0.39)
0.18
(0.08 to 0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Arm A (Bevacizumab + Dasatinib), Phase II: Arm B (Bevacizumab + Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.052 to 0.262
Estimation Comments Difference in proportion
3.Secondary Outcome
Title Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II)
Hide Description Adverse events were collected systematically at the end of each cycle and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Events are scored as: 1="Mild symptoms", 2= "Moderate", 3="Severe", 4="Life-threatening", and 5="Death". The number of patients reporting a grade 3 or higher event regardless of attribution are summarized here. A complete list of all adverse events reported during treatment can be found in the Adverse Events Section.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Phase II patients treated and evaluated for adverse events are included in this Phase II endpoint analysis.
Arm/Group Title Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Hide Arm/Group Description:
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 83 38
Measure Type: Number
Unit of Measure: participants
Grade 3 Adverse Event 42 23
Grade 4 Adverse Event 8 2
Grade 5 Adverse Event 5 3
4.Secondary Outcome
Title Overall Survival (Phase II)
Hide Description Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both arms of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible Phase II patients are included in this Phase II endpoint analysis.
Arm/Group Title Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Hide Arm/Group Description:
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 83 38
Median (95% Confidence Interval)
Unit of Measure: months
7.3
(6.2 to 8.7)
7.9
(6.6 to 11.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Arm A (Bevacizumab + Dasatinib), Phase II: Arm B (Bevacizumab + Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method Kaplan Meier
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.61 to 1.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time-to-disease Progression (Phase II)
Hide Description Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. Patients who experience major treatment violations will be censored for progression on the date the treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible Phase II patients are included in this Phase II endpoint analysis.
Arm/Group Title Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Hide Arm/Group Description:
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 83 38
Median (95% Confidence Interval)
Unit of Measure: months
3.3
(2.79 to 4.6)
3.5
(2.83 to 4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Arm A (Bevacizumab + Dasatinib), Phase II: Arm B (Bevacizumab + Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Kaplan Meier
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.76 to 1.7
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)
Hide Description FACT-Br questionnaires were used to assess QOL at every other cycle of treatment (prior to cycles 3, 5, 7, etc.). FACT-Br includes 50 questions used to assess patients' self-assessment in 4 broad categories: Physical, Social/Family, Emotional, and Function Well-being. Scores range from 0="Not at all", 1="A little bit", 2="Somewhat", 3="Quite a bit", 4="Very Much". Higher scores can be interpreted as having higher quality of life. The scores for all 50 questions were summed to give a total score per patient per cycle. Therefore the possible range is from 0 to 200. Below is the reported mean and standard deviation for patients at baseline and during cycles 2, 4, 6, 8, and 10.
Time Frame Baseline to cycle 10 (20 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All Phase II patients that began treatment and submitted at least one FACT-Br questionnaire were included in this analysis.
Arm/Group Title Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Hide Arm/Group Description:
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 77 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 0 Number Analyzed 77 participants 34 participants
139.5  (26.2) 138.3  (22.4)
Cycle 2 Number Analyzed 55 participants 23 participants
131.2  (27.9) 133.5  (23.5)
Cycle 4 Number Analyzed 29 participants 16 participants
137.6  (30.1) 137.4  (23.1)
Cycle 6 Number Analyzed 30 participants 13 participants
140.1  (29.0) 137.7  (25.7)
Cycle 8 Number Analyzed 17 participants 9 participants
142.3  (30.2) 142.8  (31.1)
Cycle10 Number Analyzed 12 participants 5 participants
142.1  (34.9) 149.3  (34.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Arm A (Bevacizumab + Dasatinib), Phase II: Arm B (Bevacizumab + Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.223
Estimation Comments The estimate is the net difference between Arm A and Arm B total score using information from all cycles. A negative value means that Arm A has a lower quality of life and a positive value means Arm A has a higher reported quality of life.
7.Secondary Outcome
Title Objective Response (Phase II)
Hide Description Objective response to treatment will be determined by the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The percentage of patients in each response category will be summarized, 95% confidence intervals calculated, and rates between the 2 arms will be compared using a Fisher’s Exact test. For bi-dimensionally measurable disease, CR: total disappearance of all tumor and that patients be on no corticosteroids or on only adrenal replacement maintenance; PR: ≥ 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions, and stable or decreasing steroid dosing; PD: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions; REGR: unequivocal reduction in extent of contrast-enhancement, or a decrease in mass effect, no new lesions (for evaluable disease); SD: failure to qualify for CR, PR,REGR or PD.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible Phase II patients are included in this Phase II endpoint analysis.
Arm/Group Title Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Hide Arm/Group Description:
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 83 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
2.4
(0.5 to 7.4)
2.6
(0 to 11.8)
PR
2.4
(0.5 to 7.4)
5.3
(1.1 to 15.3)
REGR
10.8
(6.3 to 17.9)
18.4
(10.1 to 30.9)
SD
57.8
(48.8 to 66.4)
57.9
(44.6 to 70.1)
PD
12.0
(7.2 to 19.3)
5.3
(1.1 to 15.3)
Missing/Unknown
14.5
(9.1 to 22.0)
10.5
(4.4 to 21.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Arm A (Bevacizumab + Dasatinib), Phase II: Arm B (Bevacizumab + Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6325
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Adverse events are assessed 21 days prior to registration, prior to each new cycle, and at time of progression, withdrawal or removal from the study up to 3 years from registration.
Adverse Event Reporting Description CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011.
 
Arm/Group Title Phase I: Dose Level 0 Phase I: Dose Level 1 Phase I: Dose Level 2 Phase I: Dose Level 3 Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Hide Arm/Group Description Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Phase I: Dose Level 0 Phase I: Dose Level 1 Phase I: Dose Level 2 Phase I: Dose Level 3 Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: Dose Level 0 Phase I: Dose Level 1 Phase I: Dose Level 2 Phase I: Dose Level 3 Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      1/4 (25.00%)      2/3 (66.67%)      1/6 (16.67%)      32/84 (38.10%)      18/39 (46.15%)    
Blood and lymphatic system disorders             
Hemoglobin decreased  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Leukocytosis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Cardiac disorders             
Cardiac disorder  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Myocardial ischemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Sinus arrhythmia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Sinus tachycardia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Eye disorders             
Eye disorders - Other, specify  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Optic nerve disorder  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  2
Gastrointestinal disorders             
Abdominal pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Anal hemorrhage  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Colitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Colonic perforation  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Diarrhea  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 3/84 (3.57%)  3 0/39 (0.00%)  0
Ear, nose and throat examination abnormal  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Ileal obstruction  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Jejunal perforation  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Nausea  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  3 1/39 (2.56%)  1
Rectal hemorrhage  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Retroperitoneal hemorrhage  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Vomiting  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
General disorders             
Chest pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Death  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Disease progression  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Edema limbs  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Fatigue  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 3/84 (3.57%)  3 3/39 (7.69%)  4
Fever  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 3/39 (7.69%)  3
Gait abnormal  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Sudden death  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/84 (0.00%)  0 0/39 (0.00%)  0
Infections and infestations             
Bladder infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Catheter related infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Lung infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Pneumonia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  3 1/39 (2.56%)  1
Sepsis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 2/39 (5.13%)  2
Soft tissue infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Urinary tract infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Wound infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Injury, poisoning and procedural complications             
Fracture  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 2/39 (5.13%)  21
Intraoperative complications  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Wound dehiscence  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Investigations             
Bilirubin increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Creatinine increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/84 (0.00%)  0 0/39 (0.00%)  0
Laboratory test abnormal  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/84 (0.00%)  0 0/39 (0.00%)  0
Neutrophil count decreased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Platelet count decreased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Weight loss  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Metabolism and nutrition disorders             
Anorexia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/84 (2.38%)  2 0/39 (0.00%)  0
Blood glucose increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Dehydration  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/84 (2.38%)  2 1/39 (2.56%)  1
Serum phosphate decreased  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Generalized muscle weakness  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Muscle weakness  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/84 (4.76%)  5 0/39 (0.00%)  0
Muscle weakness left-sided  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Muscle weakness lower limb  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 2/39 (5.13%)  2
Muscle weakness right-sided  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Musculoskeletal disorder  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Nervous system disorders             
Ataxia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 1/39 (2.56%)  1
Cognitive disturbance  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Depressed level of consciousness  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 2/39 (5.13%)  2
Dysphasia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Extrapyramidal disorder  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Headache  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Ischemia cerebrovascular  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  2
Memory impairment  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Seizure  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  3 4/39 (10.26%)  4
Somnolence  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Syncope  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Psychiatric disorders             
Confusion  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 2/39 (5.13%)  4
Renal and urinary disorders             
Bladder hemorrhage  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Cystitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Aspiration  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Atelectasis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 0/39 (0.00%)  0
Dyspnea  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Epistaxis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Hypoxia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Pleural effusion  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 0/39 (0.00%)  0
Respiratory disorder  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  3 1/39 (2.56%)  1
Skin and subcutaneous tissue disorders             
Rash desquamating  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Vascular disorders             
Hematoma  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Hypertension  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Hypotension  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Thrombosis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 3/39 (7.69%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I: Dose Level 0 Phase I: Dose Level 1 Phase I: Dose Level 2 Phase I: Dose Level 3 Phase II: Arm A (Bevacizumab + Dasatinib) Phase II: Arm B (Bevacizumab + Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      83/84 (98.81%)      39/39 (100.00%)    
Blood and lymphatic system disorders             
Hemoglobin decreased  1  3/3 (100.00%)  28 2/4 (50.00%)  24 2/3 (66.67%)  22 5/6 (83.33%)  20 67/84 (79.76%)  432 14/39 (35.90%)  38
Cardiac disorders             
Atrial fibrillation  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Sinus tachycardia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Ear and labyrinth disorders             
Hearing test abnormal  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  2
Tinnitus  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Endocrine disorders             
Cushingoid  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/84 (0.00%)  0 0/39 (0.00%)  0
Eye disorders             
Cataract  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  2
Eye disorder  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Gastrointestinal disorders             
Abdominal distension  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Abdominal pain  1  0/3 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 10/84 (11.90%)  17 7/39 (17.95%)  14
Anal pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Constipation  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 6/84 (7.14%)  8 0/39 (0.00%)  0
Diarrhea  1  1/3 (33.33%)  6 1/4 (25.00%)  6 1/3 (33.33%)  2 3/6 (50.00%)  13 50/84 (59.52%)  186 12/39 (30.77%)  51
Dyspepsia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  3 3/84 (3.57%)  4 0/39 (0.00%)  0
Dysphagia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 2/39 (5.13%)  9
Ear, nose and throat examination abnormal  1  0/3 (0.00%)  0 1/4 (25.00%)  6 1/3 (33.33%)  2 0/6 (0.00%)  0 11/84 (13.10%)  17 2/39 (5.13%)  3
Gastrointestinal pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  3 0/39 (0.00%)  0
Hemorrhoids  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Ileus  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Mucositis oral  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 8/84 (9.52%)  13 4/39 (10.26%)  9
Nausea  1  1/3 (33.33%)  1 1/4 (25.00%)  2 1/3 (33.33%)  1 2/6 (33.33%)  3 31/84 (36.90%)  82 11/39 (28.21%)  37
Tooth disorder  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Upper gastrointestinal hemorrhage  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/84 (0.00%)  0 0/39 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 17/84 (20.24%)  35 4/39 (10.26%)  6
General disorders             
Edema limbs  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 1/39 (2.56%)  1
Facial pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Fatigue  1  3/3 (100.00%)  50 4/4 (100.00%)  37 3/3 (100.00%)  29 6/6 (100.00%)  57 73/84 (86.90%)  478 35/39 (89.74%)  241
Fever  1  1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 16/84 (19.05%)  18 2/39 (5.13%)  2
Flu-like symptoms  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 1/39 (2.56%)  1
Gait abnormal  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Infections and infestations             
Abdominal infection  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Appendicitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Bladder infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/84 (1.19%)  1 0/39 (0.00%)  0
Bone infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Bronchitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  3 0/39 (0.00%)  0
Encephalitis infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Gingival infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 1/39 (2.56%)  1
Joint infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Mucosal infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 0/39 (0.00%)  0
Opportunistic infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Otitis externa  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Pneumonia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 0/39 (0.00%)  0
Sinusitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  2
Skin infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  3 1/39 (2.56%)  1
Tooth infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Upper respiratory infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Urinary tract infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/84 (4.76%)  6 0/39 (0.00%)  0
Wound infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Injury, poisoning and procedural complications             
Fracture  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/84 (4.76%)  4 1/39 (2.56%)  1
Wound dehiscence  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/84 (1.19%)  1 0/39 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 5/84 (5.95%)  10 2/39 (5.13%)  2
Aspartate aminotransferase increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/84 (4.76%)  11 1/39 (2.56%)  1
Blood gonadotrophin abnormal  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Cardiac troponin I increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Creatinine increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  4 0/39 (0.00%)  0
Electrocardiogram QTc interval prolonged  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Investigations - Other, specify  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Leukocyte count decreased  1  2/3 (66.67%)  14 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 29/84 (34.52%)  97 6/39 (15.38%)  13
Lymphocyte count decreased  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 2/6 (33.33%)  3 13/84 (15.48%)  35 7/39 (17.95%)  19
Lymphocyte count increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/84 (0.00%)  0 0/39 (0.00%)  0
Neutrophil count decreased  1  2/3 (66.67%)  23 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 14/84 (16.67%)  51 1/39 (2.56%)  3
Platelet count decreased  1  2/3 (66.67%)  16 1/4 (25.00%)  1 2/3 (66.67%)  4 3/6 (50.00%)  5 47/84 (55.95%)  180 13/39 (33.33%)  29
Weight gain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  6 0/39 (0.00%)  0
Weight loss  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 27/84 (32.14%)  182 11/39 (28.21%)  105
Metabolism and nutrition disorders             
Anorexia  1  0/3 (0.00%)  0 1/4 (25.00%)  30 0/3 (0.00%)  0 0/6 (0.00%)  0 34/84 (40.48%)  114 13/39 (33.33%)  70
Blood glucose increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/84 (4.76%)  8 1/39 (2.56%)  1
Dehydration  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Hypermagnesemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Hypoalbuminemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Hypocalcemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 1/39 (2.56%)  1
Hypokalemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/84 (0.00%)  0 1/39 (2.56%)  1
Hypophosphatemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  3 1/39 (2.56%)  1
Serum albumin decreased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 8/84 (9.52%)  12 0/39 (0.00%)  0
Serum calcium decreased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 8/84 (9.52%)  14 0/39 (0.00%)  0
Serum phosphate decreased  1  1/3 (33.33%)  3 2/4 (50.00%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 21/84 (25.00%)  33 3/39 (7.69%)  3
Serum potassium decreased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  3 1/39 (2.56%)  1
Serum potassium increased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Serum sodium decreased  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 6/84 (7.14%)  8 2/39 (5.13%)  4
Generalized muscle weakness  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Joint pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  2
Muscle weakness  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 5/84 (5.95%)  48 2/39 (5.13%)  7
Muscle weakness left-sided  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  5
Muscle weakness lower limb  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  6 3/39 (7.69%)  4
Muscle weakness right-sided  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  1
Muscle weakness upper limb  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 2/39 (5.13%)  2
Myalgia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Neck pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 2/39 (5.13%)  19
Nervous system disorders             
Acoustic nerve disorder NOS  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  2
Ataxia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Central nervous system necrosis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Cognitive disturbance  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/84 (4.76%)  6 1/39 (2.56%)  2
Depressed level of consciousness  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Dizziness  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 3/39 (7.69%)  3
Dysarthria  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Dysgeusia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Dysphasia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  3 0/39 (0.00%)  0
Headache  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 7/84 (8.33%)  12 4/39 (10.26%)  4
Memory impairment  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  2
Mini mental status examination abnormal  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Nervous system disorders - Other, specify  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Neurological disorder NOS  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 2/39 (5.13%)  3
Peripheral motor neuropathy  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Peripheral sensory neuropathy  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  3 0/39 (0.00%)  0
Seizure  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 5/84 (5.95%)  7 2/39 (5.13%)  2
Speech disorder  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  3 5/39 (12.82%)  22
Taste alteration  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  5 0/39 (0.00%)  0
Psychiatric disorders             
Agitation  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  5 1/39 (2.56%)  3
Anxiety  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 5/84 (5.95%)  8 0/39 (0.00%)  0
Confusion  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/84 (4.76%)  7 4/39 (10.26%)  7
Depression  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 5/84 (5.95%)  14 3/39 (7.69%)  14
Insomnia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 5/84 (5.95%)  5 2/39 (5.13%)  2
Personality change  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  10 0/39 (0.00%)  0
Renal and urinary disorders             
Protein urine positive  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/84 (2.38%)  15 1/39 (2.56%)  5
Renal failure  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/84 (0.00%)  0 0/39 (0.00%)  0
Urinary incontinence  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  2 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Allergic rhinitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Apnea  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  2 0/39 (0.00%)  0
Aspiration  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Atelectasis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  3 0/39 (0.00%)  0
Cough  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  3 1/39 (2.56%)  2
Dyspnea  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/84 (3.57%)  5 0/39 (0.00%)  0
Hemorrhage nasal  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Pharyngeal examination abnormal  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Pharyngeal mucositis  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 2/39 (5.13%)  7
Pleural effusion  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 6/84 (7.14%)  14 0/39 (0.00%)  0
Pneumonitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/84 (1.19%)  1 0/39 (0.00%)  0
Voice alteration  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Skin and subcutaneous tissue disorders             
Decubitus ulcer  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  10 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Dry skin  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/84 (0.00%)  0 1/39 (2.56%)  1
Pruritus  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Rash acneiform  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/84 (2.38%)  4 0/39 (0.00%)  0
Rash desquamating  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  16 0/84 (0.00%)  0 0/39 (0.00%)  0
Skin ulceration  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 0/39 (0.00%)  0
Urticaria  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/84 (1.19%)  1 1/39 (2.56%)  2
Vascular disorders             
Hemorrhage  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/84 (0.00%)  0 0/39 (0.00%)  0
Hypertension  1  0/3 (0.00%)  0 2/4 (50.00%)  11 2/3 (66.67%)  4 4/6 (66.67%)  14 28/84 (33.33%)  131 18/39 (46.15%)  92
Thrombosis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/84 (4.76%)  6 2/39 (5.13%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Evanthia Galanis, M.D.
Organization: Mayo Clinic
Phone: (507) 284-7733
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00892177     History of Changes
Other Study ID Numbers: NCCTG-N0872
NCI-2011-01921 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000641746 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: May 1, 2009
First Posted: May 4, 2009
Results First Submitted: March 13, 2017
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017