Trial Outcomes & Findings for Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer (NCT NCT00439270)
NCT ID: NCT00439270
Last Updated: 2014-03-28
Results Overview
MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for \>14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for \>14 days, grade 3-4 asthenia/fatigue, any other grade \>=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for \>14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)
Results posted on
2014-03-28
Participant Flow
A total of 49 participants were enrolled in the study, and 46 entered the treatment period and received at least 1 dose of dasatinib.
Participant milestones
| Measure |
Dasatinib, 50 mg + Docetaxel, 60 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
|---|---|---|---|---|---|
|
Phase 1 (18.1 Months)
STARTED
|
3
|
3
|
3
|
4
|
3
|
|
Phase 1 (18.1 Months)
COMPLETED
|
0
|
0
|
0
|
4
|
0
|
|
Phase 1 (18.1 Months)
NOT COMPLETED
|
3
|
3
|
3
|
0
|
3
|
|
Phase 2 (51.6 Months)
STARTED
|
0
|
0
|
0
|
34
|
0
|
|
Phase 2 (51.6 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 (51.6 Months)
NOT COMPLETED
|
0
|
0
|
0
|
34
|
0
|
Reasons for withdrawal
| Measure |
Dasatinib, 50 mg + Docetaxel, 60 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
|---|---|---|---|---|---|
|
Phase 1 (18.1 Months)
Disease progression
|
3
|
2
|
3
|
0
|
3
|
|
Phase 1 (18.1 Months)
Study drug toxicity
|
0
|
1
|
0
|
0
|
0
|
|
Phase 2 (51.6 Months)
Disease progression
|
0
|
0
|
0
|
18
|
0
|
|
Phase 2 (51.6 Months)
Poor compliance/noncompliance
|
0
|
0
|
0
|
1
|
0
|
|
Phase 2 (51.6 Months)
Study drug toxicity
|
0
|
0
|
0
|
6
|
0
|
|
Phase 2 (51.6 Months)
Maximum clinical benefit
|
0
|
0
|
0
|
3
|
0
|
|
Phase 2 (51.6 Months)
No longer meets study criteria
|
0
|
0
|
0
|
1
|
0
|
|
Phase 2 (51.6 Months)
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
|
Phase 2 (51.6 Months)
Adverse event unrelated to study drug
|
0
|
0
|
0
|
2
|
0
|
|
Phase 2 (51.6 Months)
Insurance no longer covered patient care
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Dasatinib, 50 mg + Docetaxel, 60 mg/m^2
n=3 Participants
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
0 Participants
3.51 • n=5 Participants
|
1 Participants
5.03 • n=7 Participants
|
1 Participants
11.02 • n=5 Participants
|
19 Participants
8.43 • n=4 Participants
|
2 Participants
13.23 • n=21 Participants
|
23 Participants
n=8 Participants
|
|
Age, Customized
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)Population: All patients who received at least 1 dose of dasatinib in Phase 1
MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for \>14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for \>14 days, grade 3-4 asthenia/fatigue, any other grade \>=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for \>14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=16 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel
|
NA mg
Because no DLT occurred, MTD was not determined. Recommended Phase 2 dasatinib dose based on ongoing studies in chronic myelogenous leukemia and previous study in chronic refractory prostate cancer. Recommended docetaxel dose based on package insert.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)Population: All patients who received at least 1 dose of dasatinib in Phase 1
Because no dose-limiting toxicities occurred, the recommended dose of dasatinib used in Phase 2 was based on findings from ongoing studies in chronic myelogenous leukemia and experience from the previous Phase 2 study of single-agent dasatinib in chronic refractory prostate cancer. The recommended Phase 2 dose of docetaxel (75 mg/m\^2) was based on the docetaxel package insert.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=16 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2
|
100 mg
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months)Population: All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2
PSA response rate is defined as a decrease of \>=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Prostate Specific Antigen (PSA) Response
|
64.7 Percentage of participants
Interval 46.49 to 80.25
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatmentPopulation: All participants who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 and who had a PSA response
Duration of response is computed for participants with confirmed PSA response. It is measured in months from the time of the first of 2 consecutive measurements meeting the criteria for confirmed PSA response to the date of the first of 3 consecutive measurements that confirm PSA progression, the date of disease progression, or the date of death. Participants who neither progressed (PSA or disease) nor died were censored on the date of their last PSA assessment. PSA response is defined as a decrease of \>=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements. PSA progression is defined as 3 consecutive increases in PSA from baseline or nadir, each measurement at least 1 week apart. The final confirming PSA measurement had to be ≥5ng/mL higher than baseline or nadir and also represent at least a 50% increase from baseline or nadir (ie, the value is ≥1.5\*baseline or nadir PSA).
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=22 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Duration of Prostate Specific Antigen (PSA) Response
|
9.5 Months
Interval 7.1 to 25.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs lastPopulation: All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2
PFS defined as time in months from the first dosing date to the date of disease progression or the date of death. Patients who neither progressed nor died were censored on the date of their last on-study prostate specific antigen (PSA) measurement, tumor assessment, or radionuclide bone scan assessment (whichever occurred last). Disease progression defined as either of the following: progression on radionuclide bone scan, death, or at least 2 of the following: tumor progression, as defined by modified Response Evaluation Criteria in Solid Tumors; PSA progression; or investigator-defined clinical progression based on physical examination, history, symptoms, and performance status.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Number of Months of Progression-free Survival (PFS)
|
11.5 Months
Interval 8.8 to 18.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)Population: All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2
Objective response rate is defined as the percentage of participants who have achieved best responses of confirmed Complete Response (CR) or Partial Response (PR) where confirmed requires repeat evaluations for a minimum of 4 weeks after the criteria for response are first met. RECIST: CR=disappearance of clinical and radiologic evidence of target lesions; PR=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
|
44.1 Percentage of participants
Interval 27.19 to 62.11
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)Population: All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2
RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor sufficient shrinkage to qualify for PR. PD=a 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline; unequivocal progression of nonmeasurable disease/lesions as evaluated by CT scan or MRI (not as evaluated by radionuclide bone scan) and/or new lesions are present. To qualify as SD, patients had to exhibit SD for a minimum of 18 weeks. Those with evaluations noted as SD prior to 18 weeks and discontinued were reported as no change.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Complete response
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Partial response
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Stable disease
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
No change
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive disease
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Not evaluable
|
13 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of therapy to last bone scan assessment (up to 51.6 months)Population: All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2
Stable=no new lesions appeared at any 6-week assessment or new pain was not developed in an area that was previously visualized for a minimum of 18 weeks; no change=stable disease prior to 18 weeks and then discontinued treatment; progression=2 or more new areas of focal uptake or new adverse clinical symptoms in an area previously visualized; improved=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Number of Participants by Best On-study Bone Scan Assessment From Baseline
Improved
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Bone Scan Assessment From Baseline
Stable
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Bone Scan Assessment From Baseline
No change
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Bone Scan Assessment From Baseline
Progression
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants by Best On-study Bone Scan Assessment From Baseline
Not evaluable
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of therapy to last bone scan assessment (up to 51.6 months)Population: All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2
Improvement=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Improvement on Bone Scan
|
23.5 Percentage of participants
Interval 10.75 to 41.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visitPopulation: All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2, in the Phase 2 portion of the study and completed the BPI-sf at baseline. n=evaluable participants in that cycle.
The BPI-sf assessed intensity of pain in the last 24 hours as well as impact of pain on daily functions. Patients rated the severity of their pain at its worst, least, and average in the last 24 hours using an 11-point rating scale with endpoints of no pain (0 points) and pain as bad as you can imagine (11 points). They were asked to rate their present pain and pain at the time they completed the BPI-sf. Using an 11-point rating scale with endpoints of does not interfere (0 points) and completely interferes (11 points), the BPI-sf similarly assessed to what extent pain interfered with mood, walking, general activity, work, relations with others, sleep, and enjoyment of life. The BPI-sf also asked patients to mark the location of their pain on a body drawing and included other questions about pain treatment and the extent of pain relief. The BPI-sf was collected in the Phase 2 portion of the study only. For on-treatment visits, the BPI-sf was completed prior to the docetaxel infusion.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=18 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Baseline: Average of pain (n=18)
|
1.0 Units on a scale
Interval 1.0 to 5.8
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Baseline: Average of pain interference (n=18)
|
1.0 Units on a scale
Interval 0.0 to 7.3
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 2: Average of pain (n=11)
|
-0.8 Units on a scale
Interval -2.3 to 0.8
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 2: Average of pain interference (n=11)
|
0.0 Units on a scale
Interval -2.3 to 1.0
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 3: Average of pain (n=7)
|
-0.5 Units on a scale
Interval -2.0 to 0.8
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 3: Average of pain interference (n=7)
|
-0.0 Units on a scale
Interval -3.0 to 1.7
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 4: Average of pain (n=10)
|
-1.0 Units on a scale
Interval -1.5 to 0.0
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 4: Average of pain interference (n=10)
|
-0.1 Units on a scale
Interval -1.0 to 1.6
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 5: Average of pain (n=5)
|
-0.8 Units on a scale
Interval -1.5 to 2.5
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 5: Average of pain interference (n=5)
|
0.0 Units on a scale
Interval -0.6 to 4.6
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 6: Average of pain (n=9)
|
-0.8 Units on a scale
Interval -1.5 to 0.9
|
—
|
—
|
—
|
—
|
|
Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Cycle 6: Average of pain interference (n=9)
|
0.0 Units on a scale
Interval -1.0 to 4.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)Population: All participants who received at least 1 dose of dasatinib
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=46 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population
Deaths
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population
SAEs
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population
Drug-related SAEs
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population
Drug-related AEs
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population
Drug-related AEs leading to discontinuation
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population
Drug-related Grade 3 or 4 AEs
|
13 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)Population: All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort
Deaths
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort
Drug-related SAEs
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort
Drug-related AEs
|
33 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort
Drug-related AEs leading to discontinuation
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort
Drug-related Grade 3 or 4 AEs
|
12 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdosePopulation: All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel
AUC(0-10) (n=3, 1, 3, 28, 3)
|
173.13 ng.h/mL
Geometric Coefficient of Variation 54
|
71.75 ng.h/mL
Geometric Coefficient of Variation NA
Insufficient participants with events
|
149.79 ng.h/mL
Geometric Coefficient of Variation 26
|
277.07 ng.h/mL
Geometric Coefficient of Variation 54
|
461.82 ng.h/mL
Geometric Coefficient of Variation 35
|
|
Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel
AUC(tau) (n=3, 1, 3, 21, 3)
|
205.43 ng.h/mL
Geometric Coefficient of Variation 57
|
82.20 ng.h/mL
Geometric Coefficient of Variation NA
Insufficient participants with events
|
200.63 ng.h/mL
Geometric Coefficient of Variation 25
|
389.66 ng.h/mL
Geometric Coefficient of Variation 48
|
556.47 ng.h/mL
Geometric Coefficient of Variation 36
|
SECONDARY outcome
Timeframe: Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdosePopulation: All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel
Dasatinib (n=3, 1, 3, 29, 3)
|
42.70 ng/mL
Geometric Coefficient of Variation 68
|
21.99 ng/mL
Geometric Coefficient of Variation NA
Insufficient participants with events
|
30.00 ng/mL
Geometric Coefficient of Variation 17
|
83.91 ng/mL
Geometric Coefficient of Variation 74
|
164.99 ng/mL
Geometric Coefficient of Variation 26
|
|
Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel
Docetaxel (n=3, 3, 3, 34, 3)
|
2226.25 ng/mL
Geometric Coefficient of Variation 46
|
1763.34 ng/mL
Geometric Coefficient of Variation 25
|
1748.43 ng/mL
Geometric Coefficient of Variation 20
|
2125.49 ng/mL
Geometric Coefficient of Variation 33
|
2412.41 ng/mL
Geometric Coefficient of Variation 14
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdosePopulation: All patients who received at least 1 dose of dasatinib
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel
|
3085.59 ng.h/mL
Geometric Coefficient of Variation 54
|
2064.49 ng.h/mL
Geometric Coefficient of Variation 24
|
2113.37 ng.h/mL
Geometric Coefficient of Variation 23
|
2663.83 ng.h/mL
Geometric Coefficient of Variation 33
|
3283.27 ng.h/mL
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months)Population: All participants who received at least 1 dose of study drug
ULN=upper limit of normal. Graded by Common Toxicity Criteria: 1 (least severe) to 4 (life threatening ). Absolute neutrophil count (\*10\^9/L), Grade 3, \<1.0-0.5; Grade 4, \<0.5. Hemoglobin (mmol/L), Grade 3, \<4.9-4.0; Grade 4, \<4.0. Platelets (\*10\^9/L), Grade 3, \<50.0-25.0; Grade 4, \<25.0. Leukocytes (\*10\^9/L) Grade 3, \<2.0-1.0; Grade 4, \<1.0. ALP, ALT, and AST (\*ULN), Grade 3, \>5.0-20.0; Grade 4, \>20.0. Total bilirubin (\*ULN), Grade 3, \>3.0-10.0; Grade 4, \>10.0. Creatinine (\*ULN), Grade 3, \>3.0-6.0; Grade 4, \>6.0. Hypercalcemia (mmol/L), Grade 3, \>3.1-3.4; Grade 4, \>3.4. Hypocalcemia mmol/L), Grade 3, \<1.75-1.5; Grade 4, \<1.5. Hyperkalemia (mmol/L), Grade 3, \>6.0-7.0; Grade 4, \>7.0. Hypokalemia (mmol/L), Grade 3, \<3.0-2.5; Grade 4, \<2.5. Hypernatremia (mmol/L), Grade 3, \>155-160; Grade 4, \>160. Hyponatremia (mmol/L), Grade 3, \<130-120; Grade 4, \<120. Phosphorus (mmol/L), Grade 3, \<0.6-0.3; Grade 4, \<0.3. Prothrombin time (seconds), Grade 3, \>2.0; Grade 4, not defined.
Outcome measures
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 Participants
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
n=3 Participants
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
|
|---|---|---|---|---|---|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Total bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Hypokalemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Hypernatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Absolute neutrophil count
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Hemoglobin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Platelet count
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Leukocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Alanine aminotransferase (ALT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Aspartate aminotransferase (AST)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Alkaline phosphatase (ALP)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Hypercalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Hypocalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Creatinine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Hyperkalemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Hyponatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Phosphorus, inorganic
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Prothrombin time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Serious events: 14 serious events
Other events: 34 other events
Deaths: 0 deaths
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dasatinib, 50 mg + Docetaxel, 60 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 participants at risk
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
n=3 participants at risk
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 60 mg/m^2
n=3 participants at risk
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
n=3 participants at risk
Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
n=3 participants at risk
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Bronchitis
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Cellulitis
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Psychiatric disorders
Confusional state
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Immune system disorders
Drug hypersensitivity
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Renal failure acute
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Spinal cord compression
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Subcutaneous abscess
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Cardiac disorders
Cardiac failure congestive
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Mucosal inflammation
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Cardiac disorders
Diastolic dysfunction
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Fatigue
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Pyrexia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Asthenia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Gastroenteritis viral
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Infection
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
Other adverse events
| Measure |
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
n=34 participants at risk
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
n=3 participants at risk
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 60 mg/m^2
n=3 participants at risk
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m\^2.
|
Dasatinib, 50 mg + Docetaxel, 75 mg/m^2
n=3 participants at risk
Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
n=3 participants at risk
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m\^2.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.7%
5/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Face oedema
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Pain
|
17.6%
6/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.6%
6/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Sinusitis
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Vascular disorders
Thrombosis
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Urinary hesitation
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Vomiting
|
26.5%
9/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Eye disorders
Dry eye
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Eye disorders
Eye pain
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Headache
|
17.6%
6/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
23.5%
8/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Oral pain
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Weight decreased
|
14.7%
5/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.5%
9/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Blood uric acid increased
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.5%
8/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
47.1%
16/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Psychiatric disorders
Insomnia
|
17.6%
6/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Eye disorders
Lacrimation increased
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Neuropathy peripheral
|
17.6%
6/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Urinary retention
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Urinary tract infection
|
17.6%
6/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Cardiac murmur
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Constipation
|
26.5%
9/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Dysgeusia
|
50.0%
17/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Fatigue
|
79.4%
27/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
100.0%
3/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
100.0%
3/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Injury, poisoning and procedural complications
Laceration
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Pyrexia
|
17.6%
6/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.7%
5/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Cardiac disorders
Tachycardia
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Asthenia
|
14.7%
5/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Vascular disorders
Hot flush
|
14.7%
5/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Localised infection
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Oedema
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Ear and labyrinth disorders
Tinnitus
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.6%
7/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
17/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Psychiatric disorders
Depression
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Vascular disorders
Flushing
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Haemoglobin decreased
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Immune system disorders
Hypersensitivity
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Nausea
|
58.8%
20/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Rhinitis
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Tinea cruris
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
29.4%
10/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Psychiatric disorders
Anxiety
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Blood creatinine increased
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Blood urea increased
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
66.7%
2/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
14.7%
5/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Infection
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.8%
4/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Proteinuria
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Eye disorders
Vision blurred
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Weight increased
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Investigations
Activated partial thromboplastin time shortened
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
73.5%
25/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Ascites
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Chest pain
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Chills
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
73.5%
25/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Influenza like illness
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Injection site reaction
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
General disorders
Oedema peripheral
|
41.2%
14/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
23.5%
8/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.9%
2/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
3/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
|
Renal and urinary disorders
Urinary incontinence
|
2.9%
1/34 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
0.00%
0/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
33.3%
1/3 • From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER