Trial Outcomes & Findings for Trial of Dasatinib in Advanced Sarcomas (NCT NCT00464620)
NCT ID: NCT00464620
Last Updated: 2018-11-23
Results Overview
Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
366 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2018-11-23
Participant Flow
50 patients with GIST were enrolled between June 2008 and December 2009 and 48 were evaluable for response. Between May 2007 and May 2009, 200 patients with advanced, high-grade sarcoma were enrolled into the aggressive subtype for this study. 116 patients were registered beginning in July 2007 to the indolent subtype for this study.
Participant milestones
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
200
|
116
|
|
Overall Study
COMPLETED
|
48
|
198
|
109
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
7
|
Reasons for withdrawal
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
|
Overall Study
Ineligible sarcoma subtype
|
0
|
2
|
2
|
|
Overall Study
Use of prohibited concomitant medication
|
0
|
0
|
2
|
Baseline Characteristics
The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
Baseline characteristics by cohort
| Measure |
Dasatinib, 70 mg, Twice Daily
n=359 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|
|
Age, Continuous
Aggressive subtype
|
52 years
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Age, Continuous
GIST
|
60 years
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Age, Continuous
Indolent
|
54 years
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Sex: Female, Male
Aggressive subtype · Female
|
96 Participants
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Sex: Female, Male
Aggressive subtype · Male
|
104 Participants
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Sex: Female, Male
GIST · Female
|
19 Participants
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Sex: Female, Male
GIST · Male
|
31 Participants
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Sex: Female, Male
Indolent · Female
|
33 Participants
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Sex: Female, Male
Indolent · Male
|
76 Participants
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Aggressive subtype · White
|
171 Participants
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Aggressive subtype · Black
|
15 Participants
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Aggressive subtype · Asian
|
6 Participants
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Aggressive subtype · Other
|
6 Participants
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Aggressive subtype · Unknown
|
2 Participants
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Aggressive subtype · Native American
|
0 Participants
n=200 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
GIST · White
|
41 Participants
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
GIST · Black
|
3 Participants
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
GIST · Asian
|
3 Participants
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
GIST · Other
|
1 Participants
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
GIST · Unknown
|
1 Participants
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
GIST · Native American
|
1 Participants
n=50 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Indolent · White
|
94 Participants
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Indolent · Black
|
8 Participants
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Indolent · Asian
|
3 Participants
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Indolent · Other
|
4 Participants
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Indolent · Unknown
|
0 Participants
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
|
Race/Ethnicity, Customized
Indolent · Native American
|
0 Participants
n=109 Participants • The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: 116 subjects enrolled in the Indolent subtype, however 109 subjects began treatment. 50 patients enrolled in the GIST subtype, however 48 patients were evaluable. This explains the discrepancy between Overall Number of Participants Analyzed.
Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=48 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
n=198 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
n=109 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Response Rate: Number of Participants With Objective Tumor Response
|
12 Participants
|
14 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsEstimate the 6 month progression-free survival rate of "indolent" sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=109 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
6 Month Progression-free Survival Rate of "Indolent" Sarcomas Treated With Dasatinib
|
52 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsTo estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=48 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 monthsTo estimate the median time-to-progression of subjects with GIST treated with dasatinib.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=48 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Median Time-to-progression of Subjects With GIST Treated With Dasatinib.
|
2.9 months
Interval 2.0 to 5.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At 2 and 5 yearsTo estimate the overall survival rates at 2 and 5 years from registration of subjects treated with dasatinib.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=48 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
n=109 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.
2 years overall survival
|
21 Participants
|
48 Participants
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.
5 years overall survival
|
8 Participants
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsTo estimate the median time-to-progression of subjects with "indolent" sarcomas treated with dasatinib.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=109 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Median Time-to-progression of Subjects With "Indolent" Sarcomas Treated With Dasatinib.
|
5.8 months
Interval 3.7 to 7.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: The numbers analyzed in one or more rows are different because they are broken up by cohorts.
To estimate the 6 month progression-free survival rate of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, Malignant fibrous histiocytoma (MFH), rhabdomyosarcoma and MPNST treated with dasatinib.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=198 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
UPS
|
6 Participants
|
—
|
—
|
|
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
Leiomyosarcoma
|
5 Participants
|
—
|
—
|
|
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
Osteosarcoma
|
5 Participants
|
—
|
—
|
|
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
Rhabdomyosarcoma
|
0 Participants
|
—
|
—
|
|
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
Ewing's Sarcoma
|
1 Participants
|
—
|
—
|
|
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
Liposarcoma
|
0 Participants
|
—
|
—
|
|
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
MPNST
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 37 weeksTo estimate the median time-to-progression of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, MFH, rhabdomyosarcoma and MPNST treated with dasatinib.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=198 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.
|
1.9 months
Interval 0.9 to 2.2
|
—
|
—
|
SECONDARY outcome
Timeframe: At 2 and 5 yearsPopulation: The number analyzed in one or more rows differs from overall number because the rows are broken down into cohorts. The counts in the categories will not add up to the number analyzed, because those numbers represent number of participants that have reached overall survival at 2 and 5 years.
To estimate the overall survival rates at 2 and 5 years from registration of subjects enrolled in the aggressive subtype treated with dasatinib.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=198 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Osteosarcoma : 2 year overall survival rate
|
15 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Ewing's Sarcoma : 2 year overall survival rate
|
7 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Ewing's Sarcoma : 5 year overall survival rate
|
0 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Leiomyosarcoma : 2 year overall survival rate
|
21 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Leiomyosarcoma : 5 year overall survival rate
|
2 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Liposarcoma : 2 year overall survival rate
|
0 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Liposarcoma : 5 year overall survival rate
|
0 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
MPNST : 2 year overall survival rate
|
0 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
MPNST : 5 year overall survival rate
|
0 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Osteosarcoma : 5 year overall survival rate
|
0 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Rhabdomyosarcoma : 2 year overall survival rate
|
8 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Rhabdomyosarcoma : 5 year overall survival rate
|
7 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
UPS : 2 year overall survival rate
|
26 participants
|
—
|
—
|
|
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
UPS : 5 year overall survival rate
|
6 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: This data was not collected because the imaging software and work station was not obtained.
To prospectively collect uni-dimensional and bi-dimensional tumor size, tumor volumes and tumor average density determined by computer-aided automated detection in a subset of subjects with tumor predominately involving the lung
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2-4 weeks from start of treatmentPopulation: Evaluation of blood levels of drug was not performed because there was insufficient activity and the level of activity did not warrant further study.
Obtain blood samples to characterize plasma level of dasatinib and inhibition of SRC and/or FAK in peripheral blood mononuclear cells 2 hours after ingestion of drug at 2-4 weeks from the start of treatment if activity of the drug in a sarcoma subtype warrants further study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: The overall number of participants analyzed demonstrates the number of participants whose tumor samples received. The results illustrate the tissue that was able to generate tissue microarray for SRC and FAK analysis.
Obtain tumor tissue for creation of tissue microarrays to examine the frequency of kinase expression such as SRC and/or FAK in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, Alveolar soft part sarcoma (ASPS), chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma, and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the number of participants who had tissue that was able to generate tissue microarray for kinase expression.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=32 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
n=44 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
n=37 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Number of Participants With Tumors With Kinase Expression
|
11 Participants
|
24 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: The overall number of participants analyzed demonstrates the number of participants whose tumor samples were received. The results illustrate the tissue that was able to generate tissue microarray for PDGFR analysis.
Obtain tumor tissue to examine the frequency of mutations in kinases such as PDGFR in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, ASPS, chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the tissue that was able to generate tissue microarray for PDGFR analysis.
Outcome measures
| Measure |
GIST: Dasatinib, 70 mg, Twice Daily
n=32 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
n=44 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
Indolent Subtype: Dasatinib, 70 mg, Twice Daily
n=37 Participants
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|---|---|
|
Number of Participants With Tumors With Mutations in Kinases
|
11 Participants
|
24 Participants
|
16 Participants
|
Adverse Events
GIST, Aggressive, Indolent Subtypes
Serious events: 158 serious events
Other events: 314 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GIST, Aggressive, Indolent Subtypes
n=355 participants at risk
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|
|
Immune system disorders
Allergic reaction
|
0.28%
1/355 • Number of events 1
|
|
Investigations
ALT
|
0.56%
2/355 • Number of events 4
|
|
Investigations
Amylase
|
0.28%
1/355 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
1.1%
4/355 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.28%
1/355 • Number of events 1
|
|
Investigations
AST
|
0.56%
2/355 • Number of events 2
|
|
Investigations
Bilirubin
|
0.28%
1/355 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood-other
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
CNS hemorrhage
|
1.1%
4/355 • Number of events 4
|
|
Investigations
Coagulation-other
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
1.1%
4/355 • Number of events 4
|
|
Psychiatric disorders
Confusion
|
0.85%
3/355 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
1.1%
4/355 • Number of events 4
|
|
General disorders
Constitutional symptoms-other
|
0.28%
1/355 • Number of events 1
|
|
Investigations
Creatinine
|
1.4%
5/355 • Number of events 5
|
|
General disorders
Death, NOS
|
1.1%
4/355 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
11/355 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Dermatology- other
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
8/355 • Number of events 11
|
|
General disorders
Disease progression, NOS
|
2.0%
7/355 • Number of events 7
|
|
Gastrointestinal disorders
Distention
|
0.28%
1/355 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.6%
34/355 • Number of events 37
|
|
Gastrointestinal disorders
Esophagitis
|
0.28%
1/355 • Number of events 1
|
|
General disorders
Fatigue
|
2.0%
7/355 • Number of events 7
|
|
General disorders
Fever
|
4.2%
15/355 • Number of events 16
|
|
General disorders
Flu-like syndrome
|
0.28%
1/355 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.85%
3/355 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
GI Hemorrhage: lower GI
|
0.56%
2/355 • Number of events 2
|
|
Gastrointestinal disorders
GI Hemorrhage: upper GI
|
0.56%
2/355 • Number of events 2
|
|
Gastrointestinal disorders
GI Obstruction: small bowel
|
1.7%
6/355 • Number of events 6
|
|
Gastrointestinal disorders
GI Obstruction: stomach
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
GI Pain: abdomen
|
3.4%
12/355 • Number of events 12
|
|
Gastrointestinal disorders
GI Ulcer: colon
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
GI- other
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
GU Hemorrhage: urinary
|
0.56%
2/355 • Number of events 2
|
|
Renal and urinary disorders
GU Hemorrhage: vagina
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
GU Infection, 0-2 ANC: urinary tract
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
GU Infection, Unk ANC: ureter
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
GU Pain: kidney
|
0.28%
1/355 • Number of events 1
|
|
Investigations
Hemoglobin
|
3.9%
14/355 • Number of events 15
|
|
General disorders
Hemorrhage-other
|
0.56%
2/355 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.56%
2/355 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.56%
2/355 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
5/355 • Number of events 5
|
|
Vascular disorders
Hypotension
|
1.1%
4/355 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
5/355 • Number of events 5
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.28%
1/355 • Number of events 1
|
|
Infections and infestations
Infection, Unk ANC: blood
|
0.56%
2/355 • Number of events 2
|
|
Infections and infestations
Infection-other
|
1.4%
5/355 • Number of events 6
|
|
Investigations
Leukocytes
|
0.28%
1/355 • Number of events 1
|
|
Infections and infestations
Lung infection, 0-2 ANC: bronchus
|
0.28%
1/355 • Number of events 1
|
|
Infections and infestations
Lung Infection, 3-4 ANC: bronchus
|
0.28%
1/355 • Number of events 1
|
|
Infections and infestations
Lung Infection, Unk ANC: lung
|
0.28%
1/355 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung Pain
|
2.3%
8/355 • Number of events 8
|
|
Psychiatric disorders
Anxiety
|
0.28%
1/355 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.7%
6/355 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Musculo. Pain
|
4.8%
17/355 • Number of events 17
|
|
Gastrointestinal disorders
Nausea
|
5.1%
18/355 • Number of events 20
|
|
Nervous system disorders
Neuropathy- sensory
|
0.28%
1/355 • Number of events 1
|
|
Investigations
Neutrophils
|
0.56%
2/355 • Number of events 2
|
|
General disorders
Pain
|
1.4%
5/355 • Number of events 5
|
|
Cardiac disorders
Pericardial effusion
|
0.28%
1/355 • Number of events 1
|
|
Investigations
Platelets
|
0.28%
1/355 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.5%
30/355 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.85%
3/355 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-other
|
2.3%
8/355 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.56%
2/355 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
2.0%
7/355 • Number of events 7
|
|
Nervous system disorders
Seizure
|
0.28%
1/355 • Number of events 1
|
|
Reproductive system and breast disorders
Reproductive pain: pelvis
|
0.28%
1/355 • Number of events 1
|
|
General disorders
Sudden death
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.28%
1/355 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism
|
1.7%
6/355 • Number of events 6
|
|
Cardiac disorders
Ventricular tachycardia
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
17/355 • Number of events 19
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.28%
1/355 • Number of events 1
|
|
Cardiac disorders
Congestive heart failure
|
0.56%
2/355 • Number of events 2
|
|
Cardiac disorders
Atrial Fibrillation
|
0.56%
2/355 • Number of events 2
|
|
General disorders
Multi-organ failure
|
0.28%
1/355 • Number of events 1
|
|
General disorders
Rigors/chills
|
0.28%
1/355 • Number of events 1
|
|
Vascular disorders
Sweating
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.28%
1/355 • Number of events 1
|
|
Investigations
Lymphopenia
|
0.28%
1/355 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
GI Hemorrhage- abdomen
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
GI Hemorrhage- esophagus
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
GI Hemorrhage- rectum
|
0.56%
2/355 • Number of events 2
|
|
Gastrointestinal disorders
GI Hemorrhage- stomach
|
0.28%
1/355 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.28%
1/355 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.56%
2/355 • Number of events 2
|
|
General disorders
Edema- limb
|
1.1%
4/355 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.85%
3/355 • Number of events 3
|
|
Metabolism and nutrition disorders
Lipase
|
0.28%
1/355 • Number of events 1
|
|
General disorders
Gait/walking
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Myelitis
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.56%
2/355 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.1%
4/355 • Number of events 4
|
|
Reproductive system and breast disorders
Pelvis pain
|
0.28%
1/355 • Number of events 1
|
Other adverse events
| Measure |
GIST, Aggressive, Indolent Subtypes
n=355 participants at risk
Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
12.7%
45/355 • Number of events 49
|
|
Gastrointestinal disorders
Constipation
|
7.6%
27/355 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.7%
45/355 • Number of events 55
|
|
Gastrointestinal disorders
Diarrhea
|
20.6%
73/355 • Number of events 99
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.8%
56/355 • Number of events 78
|
|
General disorders
Edema
|
9.6%
34/355 • Number of events 50
|
|
General disorders
Fatigue
|
31.8%
113/355 • Number of events 144
|
|
General disorders
Fever
|
7.6%
27/355 • Number of events 29
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.0%
25/355 • Number of events 41
|
|
Gastrointestinal disorders
Nausea
|
22.8%
81/355 • Number of events 93
|
|
General disorders
Pain- Other
|
4.8%
17/355 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.1%
43/355 • Number of events 60
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.6%
52/355 • Number of events 64
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
19/355 • Number of events 31
|
|
Gastrointestinal disorders
Vomiting
|
10.1%
36/355 • Number of events 38
|
|
Gastrointestinal disorders
GI Pain: abdomen
|
4.2%
15/355 • Number of events 22
|
|
Blood and lymphatic system disorders
Anemia
|
19.7%
70/355 • Number of events 103
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.9%
14/355 • Number of events 18
|
|
Nervous system disorders
Headache
|
14.6%
52/355 • Number of events 68
|
|
General disorders
Rigors/chills
|
4.5%
16/355 • Number of events 18
|
|
Investigations
Weight loss
|
4.8%
17/355 • Number of events 17
|
|
Cardiac disorders
Palpaitations
|
0.56%
2/355 • Number of events 2
|
|
Cardiac disorders
Prolonged QTc
|
1.1%
4/355 • Number of events 4
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
4/355 • Number of events 4
|
|
Vascular disorders
Hypertension
|
1.4%
5/355 • Number of events 6
|
|
Cardiac disorders
Cardiac- Other
|
1.1%
4/355 • Number of events 5
|
|
Cardiac disorders
Atrial Tachycardia
|
0.28%
1/355 • Number of events 1
|
|
Cardiac disorders
Sinus Bradycardia
|
0.28%
1/355 • Number of events 1
|
|
Investigations
Elevated PTT
|
0.85%
3/355 • Number of events 4
|
|
Ear and labyrinth disorders
Auditory/Ear- Other
|
0.28%
1/355 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
0.85%
3/355 • Number of events 4
|
|
Eye disorders
Dry eye
|
0.28%
1/355 • Number of events 1
|
|
Eye disorders
Blurred vision
|
0.28%
1/355 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.28%
1/355 • Number of events 1
|
|
Eye disorders
Ocular- Other
|
1.1%
4/355 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
2.3%
8/355 • Number of events 8
|
|
Vascular disorders
Sweating
|
2.3%
8/355 • Number of events 9
|
|
Gastrointestinal disorders
Heartburn
|
2.5%
9/355 • Number of events 10
|
|
Gastrointestinal disorders
Distention
|
0.85%
3/355 • Number of events 3
|
|
Gastrointestinal disorders
Dehydration
|
1.4%
5/355 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
0.85%
3/355 • Number of events 3
|
|
Gastrointestinal disorders
Taste alteration
|
2.3%
8/355 • Number of events 8
|
|
Gastrointestinal disorders
Gastritis
|
0.85%
3/355 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
4/355 • Number of events 4
|
|
Gastrointestinal disorders
Ascites
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
6/355 • Number of events 6
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.7%
6/355 • Number of events 9
|
|
Gastrointestinal disorders
Gastrointestinal- Other
|
2.0%
7/355 • Number of events 7
|
|
Gastrointestinal disorders
Mucositis
|
1.1%
4/355 • Number of events 4
|
|
Gastrointestinal disorders
Fistula
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.56%
2/355 • Number of events 2
|
|
Renal and urinary disorders
Urinary frequency
|
1.1%
4/355 • Number of events 4
|
|
Renal and urinary disorders
Urine color change
|
0.28%
1/355 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasms
|
0.56%
2/355 • Number of events 2
|
|
Renal and urinary disorders
Renal - Other
|
1.4%
5/355 • Number of events 5
|
|
Renal and urinary disorders
Ureter obstruction
|
0.28%
1/355 • Number of events 1
|
|
Investigations
Leukopenia
|
3.7%
13/355 • Number of events 19
|
|
Investigations
Neutropenia
|
4.2%
15/355 • Number of events 28
|
|
Investigations
Lymphopenia
|
3.1%
11/355 • Number of events 12
|
|
Nervous system disorders
CNS Hemorrhage
|
0.56%
2/355 • Number of events 2
|
|
Blood and lymphatic system disorders
Petechiae
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
GI Hemorrhage
|
2.5%
9/355 • Number of events 10
|
|
Renal and urinary disorders
GU Hemorrhage
|
0.85%
3/355 • Number of events 5
|
|
Infections and infestations
Lung Infection
|
3.9%
14/355 • Number of events 16
|
|
Infections and infestations
GU Infection
|
1.1%
4/355 • Number of events 4
|
|
Immune system disorders
Allergic reaction
|
0.28%
1/355 • Number of events 1
|
|
Infections and infestations
GI Infection
|
2.3%
8/355 • Number of events 11
|
|
Infections and infestations
Skin Infection
|
0.28%
1/355 • Number of events 1
|
|
Infections and infestations
Eye Infection
|
0.28%
1/355 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.28%
1/355 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.28%
1/355 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.28%
1/355 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.1%
4/355 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary- Other
|
2.5%
9/355 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.28%
1/355 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated Alkaline phosphatase
|
4.2%
15/355 • Number of events 15
|
|
Metabolism and nutrition disorders
Elevated ALT
|
2.0%
7/355 • Number of events 9
|
|
Metabolism and nutrition disorders
Elevated AST
|
2.0%
7/355 • Number of events 10
|
|
Metabolism and nutrition disorders
Elevated serum bilirubin
|
0.56%
2/355 • Number of events 2
|
|
Metabolism and nutrition disorders
Elevated creatinine
|
3.1%
11/355 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.4%
5/355 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
6/355 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.7%
6/355 • Number of events 6
|
|
Metabolism and nutrition disorders
Acidosis
|
0.28%
1/355 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.56%
2/355 • Number of events 2
|
|
Metabolism and nutrition disorders
Low serum bicarbonate
|
0.56%
2/355 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
7/355 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.85%
3/355 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.5%
9/355 • Number of events 10
|
|
Metabolism and nutrition disorders
Elevated lipase
|
0.28%
1/355 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.4%
5/355 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.0%
7/355 • Number of events 8
|
|
Psychiatric disorders
Confusion
|
1.1%
4/355 • Number of events 4
|
|
Nervous system disorders
Somnolence
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Involuntary movement
|
0.85%
3/355 • Number of events 3
|
|
Nervous system disorders
Sensory neuropathy
|
2.3%
8/355 • Number of events 8
|
|
Nervous system disorders
Leukoencephalopathy
|
0.28%
1/355 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.3%
8/355 • Number of events 10
|
|
Psychiatric disorders
Agitation
|
0.85%
3/355 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
1.1%
4/355 • Number of events 5
|
|
Psychiatric disorders
Depression
|
2.0%
7/355 • Number of events 8
|
|
Vascular disorders
Flushing
|
1.4%
5/355 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.28%
1/355 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
5/355 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.85%
3/355 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.28%
1/355 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.85%
3/355 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bruising
|
0.56%
2/355 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.56%
2/355 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.28%
1/355 • Number of events 1
|
|
General disorders
Flu-like syndrome
|
0.85%
3/355 • Number of events 3
|
|
Vascular disorders
Phlebitis
|
0.28%
1/355 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism
|
0.28%
1/355 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic pain
|
0.28%
1/355 • Number of events 1
|
|
Gastrointestinal disorders
GI Pain
|
4.2%
15/355 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Lung Pain
|
4.8%
17/355 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
18.9%
67/355 • Number of events 100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
2.8%
10/355 • Number of events 11
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.28%
1/355 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvis pain
|
1.1%
4/355 • Number of events 4
|
|
Reproductive system and breast disorders
Breast pain
|
0.56%
2/355 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
0.28%
1/355 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.28%
1/355 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology- Other
|
2.3%
8/355 • Number of events 9
|
|
Vascular disorders
Vascular- Other
|
0.28%
1/355 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place