Trial Outcomes & Findings for Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer (NCT NCT02499835)
NCT ID: NCT02499835
Last Updated: 2023-08-01
Results Overview
Toxicities will be summarized by type, as reported in the adverse events section, and total events calculated per arm.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Up to 23 months (Up to 12 months after completion of study treatment)
Results posted on
2023-08-01
Participant Flow
Participants were enrolled from UW Hospital and Clinics from July 2015 to September 2020
Participant milestones
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
20
|
20
|
|
Overall Study
COMPLETED
|
10
|
9
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
18
|
16
|
Reasons for withdrawal
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
3
|
18
|
7
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease progression
|
2
|
1
|
0
|
7
|
Baseline Characteristics
Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 Participants
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
40-49 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
50-59 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Customized
60-69 years
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Customized
70-79 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age, Customized
80-89 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 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
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
66 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 23 months (Up to 12 months after completion of study treatment)Toxicities will be summarized by type, as reported in the adverse events section, and total events calculated per arm.
Outcome measures
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 Participants
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Overall Combined Study
Combination of results from all 4 arms of the study
|
|---|---|---|---|---|---|
|
Incidence of Adverse Events, Using the National Cancer Common Terminology Criteria, Version 4
|
117 Adverse events
|
173 Adverse events
|
163 Adverse events
|
225 Adverse events
|
—
|
PRIMARY outcome
Timeframe: 6 months6-month progression-free survival rate will be reported for each arm, and for overall combined study. Progression is at least a 20% increase in the sum of diameters of target lesions and a 0.5cm minimum increase, or the appearance of one or more new lesions. In order to evaluate the 6-month progression-free rate as a function of baseline time point (pretreatment or 3-months post treatment), analysis will be conducted using two different baseline values: date of randomization, and 3-months disease assessment. Central tendency is appropriate due to 20% increase and measurements being a mean of growth across time periods.
Outcome measures
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 Participants
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Overall Combined Study
n=66 Participants
Combination of results from all 4 arms of the study
|
|---|---|---|---|---|---|
|
6-month Progression Free Survival Rate
|
31 percent probability
Interval 4.0 to 58.0
|
45 percent probability
Interval 16.0 to 74.0
|
44 percent probability
Interval 1.0 to 87.0
|
62 percent probability
Interval 37.0 to 87.0
|
47 percent probability
Interval 23.0 to 63.0
|
PRIMARY outcome
Timeframe: Up to 2 yearsMedian time to radiographic progression will be estimated for each, and for both study arms combined, using Kaplan-Meier method. Log-rank test will be used to perform comparison of time to radiographic progression between study arms. A one-sided 0.10 significance level will be used to conduct the comparison of the 6-month progression-free survival rate and time to radiographic progression between study arms. In order to evaluate the median time to radiographic progression as a function of baseline time point (pretreatment or 3-months post treatment), analysis will be conducted.
Outcome measures
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 Participants
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Overall Combined Study
n=66 Participants
Combination of results from all 4 arms of the study
|
|---|---|---|---|---|---|
|
Median Time to Radiographic Progression
|
5.3 months
Interval 2.6 to 5.4
|
5.6 months
Interval 5.0 to 11.3
|
5.6 months
Interval 4.6 to 12.0
|
8.1 months
Interval 5.3 to 10.8
|
5.6 months
Interval 5.4 to 10.8
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Only 25 of the 66 participants had measurable disease. These numbers reflect the number of participants with measurable disease per arm, and the number reported below reflect how many participants with measurable disease had an objective response rate.
Will be calculated for each study arm and for all arms combined. Complete response is the disappearance of all target lesions. Partial response is at least 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=6 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=3 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=11 Participants
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=5 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Overall Combined Study
n=25 Participants
Combination of results from all 4 arms of the study
|
|---|---|---|---|---|---|
|
Number of Participants Who Have an Objective Response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsWill be calculated for each study arm and for all arms combined. PSA complete response is a decrease in PSA to ,0.2 ng/mL; partial response is greater than or equal to 50% reduction in baseline PSA.
Outcome measures
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 Participants
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Overall Combined Study
n=66 Participants
Combination of results from all 4 arms of the study
|
|---|---|---|---|---|---|
|
Number of Participants Who Have a PSA Response
Any PSA decline
|
8 Participants
|
1 Participants
|
6 Participants
|
8 Participants
|
23 Participants
|
|
Number of Participants Who Have a PSA Response
PSA decline >50%
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsNumber of PAP-specific immune responses will be summarized in tabular format for each study arm and all study arms combined. A significant antigen-specific response resulting from immunization will be defined as a PAP specific response.
Outcome measures
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 Participants
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Overall Combined Study
n=66 Participants
Combination of results from all 4 arms of the study
|
|---|---|---|---|---|---|
|
PAP-specific Immune Response
|
4 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsNumber and frequencies of PAP-specific T-cell responses will be summarized in tabular format.
Outcome measures
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 Participants
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 Participants
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Overall Combined Study
Combination of results from all 4 arms of the study
|
|---|---|---|---|---|---|
|
PAP-specific T-cell Response
|
4 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to day 85Population: Data was not collected because of insufficient sample size; therefore, this analysis was not performed
PD-1 and PD-L1 expression levels will be summarized in terms of means, standard deviations and ranges for each study arm separately and for both arms combined. A linear regression model or a negative binomial regression model will be utilized to evaluate effects of schedule (concurrent versus delayed administration pembrolizumab) on PD-1 expression on number of circulating T cells, and PD-L1 expression on number of circulating epithelial cells. Choice of the model will be dependent on distribution of outcome variables (number of circulating T-cells and number of circulating epithelial cells).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 85Population: Data was not collected due to insufficient sample size; therefoe, this analysis was not performed
PD-1 and PD-L1 expression levels will be summarized in terms of means, standard deviations and ranges for each study arm separately and for both arms combined. A linear regression model or a negative binomial regression model will be utilized to evaluate effects of schedule (concurrent versus delayed administration pembrolizumab) on PD-1 expression on number of circulating T cells, and PD-L1 expression on number of circulating epithelial cells. Choice of the model will be dependent on distribution of outcome variables (number of circulating T-cells and number of circulating epithelial cells).
Outcome measures
Outcome data not reported
Adverse Events
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 13 deaths
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 9 deaths
Extended Treatment Arm III
Serious events: 4 serious events
Other events: 19 other events
Deaths: 16 deaths
Extended Treatment Arm IV
Serious events: 3 serious events
Other events: 19 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 participants at risk
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 participants at risk
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 participants at risk
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 participants at risk
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
|---|---|---|---|---|
|
Nervous system disorders
Stroke
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
Other adverse events
| Measure |
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab)
n=13 participants at risk
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab)
n=13 participants at risk
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm III
n=20 participants at risk
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
Extended Treatment Arm IV
n=20 participants at risk
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Pembrolizumab: Given IV
pTVG-HP Plasmid DNA Vaccine: Given ID
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
46.2%
6/13 • Number of events 7 • From time of informed consent up to 23 months.
|
46.2%
6/13 • Number of events 8 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
60.0%
12/20 • Number of events 16 • From time of informed consent up to 23 months.
|
|
General disorders
Injection site reaction
|
38.5%
5/13 • Number of events 20 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 3 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
20.0%
4/20 • Number of events 18 • From time of informed consent up to 23 months.
|
|
General disorders
Chills
|
23.1%
3/13 • Number of events 3 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 3 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
25.0%
5/20 • Number of events 8 • From time of informed consent up to 23 months.
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 3 • From time of informed consent up to 23 months.
|
|
General disorders
Edema limbs
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
General disorders
Flu like symptoms
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
General disorders
Infusion related reaction
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 5 • From time of informed consent up to 23 months.
|
|
General disorders
Malaise
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
General disorders
Fever
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 5 • From time of informed consent up to 23 months.
|
|
General disorders
Irritability
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
General disorders
Multi-organ failure
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
46.2%
6/13 • Number of events 8 • From time of informed consent up to 23 months.
|
38.5%
5/13 • Number of events 8 • From time of informed consent up to 23 months.
|
25.0%
5/20 • Number of events 8 • From time of informed consent up to 23 months.
|
90.0%
18/20 • Number of events 26 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
23.1%
3/13 • Number of events 4 • From time of informed consent up to 23 months.
|
38.5%
5/13 • Number of events 6 • From time of informed consent up to 23 months.
|
20.0%
4/20 • Number of events 5 • From time of informed consent up to 23 months.
|
75.0%
15/20 • Number of events 18 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 3 • From time of informed consent up to 23 months.
|
30.0%
6/20 • Number of events 7 • From time of informed consent up to 23 months.
|
50.0%
10/20 • Number of events 13 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13 • Number of events 4 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 3 • From time of informed consent up to 23 months.
|
15.0%
3/20 • Number of events 4 • From time of informed consent up to 23 months.
|
40.0%
8/20 • Number of events 12 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
23.1%
3/13 • Number of events 3 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
40.0%
8/20 • Number of events 10 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
23.1%
3/13 • Number of events 3 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
30.0%
6/20 • Number of events 7 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
15.0%
3/20 • Number of events 3 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
15.0%
3/20 • Number of events 3 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
3/13 • Number of events 4 • From time of informed consent up to 23 months.
|
38.5%
5/13 • Number of events 10 • From time of informed consent up to 23 months.
|
35.0%
7/20 • Number of events 11 • From time of informed consent up to 23 months.
|
90.0%
18/20 • Number of events 28 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
30.8%
4/13 • Number of events 4 • From time of informed consent up to 23 months.
|
20.0%
4/20 • Number of events 5 • From time of informed consent up to 23 months.
|
80.0%
16/20 • Number of events 18 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
25.0%
5/20 • Number of events 5 • From time of informed consent up to 23 months.
|
60.0%
12/20 • Number of events 13 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Dry mouth
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
23.1%
3/13 • Number of events 3 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
35.0%
7/20 • Number of events 7 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
23.1%
3/13 • Number of events 3 • From time of informed consent up to 23 months.
|
15.0%
3/20 • Number of events 4 • From time of informed consent up to 23 months.
|
35.0%
7/20 • Number of events 8 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 5 • From time of informed consent up to 23 months.
|
20.0%
4/20 • Number of events 7 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Colitis
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
20.0%
4/20 • Number of events 4 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
4/13 • Number of events 4 • From time of informed consent up to 23 months.
|
61.5%
8/13 • Number of events 8 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 4 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
30.0%
6/20 • Number of events 8 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.1%
3/13 • Number of events 5 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 4 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
30.8%
4/13 • Number of events 4 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Endocrine disorders
Hyperthyroidism
|
38.5%
5/13 • Number of events 6 • From time of informed consent up to 23 months.
|
23.1%
3/13 • Number of events 3 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
25.0%
5/20 • Number of events 8 • From time of informed consent up to 23 months.
|
|
Endocrine disorders
Hypothyroidism
|
38.5%
5/13 • Number of events 6 • From time of informed consent up to 23 months.
|
23.1%
3/13 • Number of events 3 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
20.0%
4/20 • Number of events 4 • From time of informed consent up to 23 months.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
23.1%
3/13 • Number of events 5 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Dizziness
|
30.8%
4/13 • Number of events 5 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
15.0%
3/20 • Number of events 4 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Facial muscle weakness
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Stroke
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Number of events 3 • From time of informed consent up to 23 months.
|
23.1%
3/13 • Number of events 3 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
15.0%
3/20 • Number of events 4 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Vascular disorders
Hypertension
|
30.8%
4/13 • Number of events 9 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
25.0%
5/20 • Number of events 5 • From time of informed consent up to 23 months.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
15.0%
3/20 • Number of events 3 • From time of informed consent up to 23 months.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 4 • From time of informed consent up to 23 months.
|
|
Vascular disorders
Hematoma
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 3 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 4 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Investigations
Weight loss
|
15.4%
2/13 • Number of events 3 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 4 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Investigations
Serum amylase increased
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Investigations
Cholesterol high
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Investigations
INR increased
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Investigations
Weight gain
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.1%
3/13 • Number of events 4 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
15.0%
3/20 • Number of events 7 • From time of informed consent up to 23 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
15.4%
2/13 • Number of events 3 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 4 • From time of informed consent up to 23 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Lung infection
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Lip infection
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
23.1%
3/13 • Number of events 6 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.7%
1/13 • Number of events 2 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 3 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Eye disorders
Floaters
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Eye disorders
Glaucoma
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Injury, poisoning and procedural complications
Fall
|
15.4%
2/13 • Number of events 2 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
20.0%
4/20 • Number of events 4 • From time of informed consent up to 23 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
5.0%
1/20 • Number of events 1 • From time of informed consent up to 23 months.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
7.7%
1/13 • Number of events 1 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/13 • From time of informed consent up to 23 months.
|
0.00%
0/20 • From time of informed consent up to 23 months.
|
10.0%
2/20 • Number of events 2 • From time of informed consent up to 23 months.
|
Additional Information
Douglas McNeel, MD
University of Wisconsin Carbone Cancer Center
Phone: 608-263-4198
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place