Trial Outcomes & Findings for Prostvac in Patients With Biochemically Recurrent Prostate Cancer (NCT NCT02649439)
NCT ID: NCT02649439
Last Updated: 2022-11-14
Results Overview
Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
6 months
Results posted on
2022-11-14
Participant Flow
A total of 97 participants were enrolled and 17/97 were screen failures who were enrolled and not treated. They are not included in the table because "potential participants who are screened for the purpose of determining eligibility, but do not participate, are not considered enrolled unless otherwise specified by the protocol", and that is not otherwise specified in the protocol.
Participant milestones
| Measure |
A/PROSTVAC Treatment
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
27
|
28
|
Reasons for withdrawal
| Measure |
A/PROSTVAC Treatment
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|
|
Overall Study
Switched to alternative treatment
|
6
|
4
|
|
Overall Study
Patient decision
|
1
|
0
|
|
Overall Study
Patient going out of country
|
1
|
0
|
|
Overall Study
To start finasteride
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Disease progression on study
|
12
|
13
|
|
Overall Study
Refused further treatment
|
1
|
0
|
|
Overall Study
Refused further follow up
|
2
|
7
|
|
Overall Study
Completed treatment phase but refused the protocol specified follow up
|
1
|
0
|
|
Overall Study
No treatment, per protocol
|
1
|
0
|
|
Overall Study
PSA DT makes ineligible
|
0
|
1
|
|
Overall Study
Rising PSA No Mets
|
0
|
1
|
|
Overall Study
Rising PSA
|
0
|
1
|
|
Overall Study
Signed follow up protocol
|
0
|
1
|
Baseline Characteristics
Prostvac in Patients With Biochemically Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
A/PROSTVAC Treatment
n=40 Participants
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=40 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Continuous
|
67.06 years
STANDARD_DEVIATION 6.48 • n=5 Participants
|
67.02 years
STANDARD_DEVIATION 6.56 • n=7 Participants
|
67.04 years
STANDARD_DEVIATION 6.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Median Prostate Specific Antigen (PSA)
|
2.98 ng/ml
n=5 Participants
|
2.82 ng/ml
n=7 Participants
|
2.9 ng/ml
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
Outcome measures
| Measure |
A/PROSTVAC Treatment
n=40 Participants
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=40 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 1
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 29
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|---|---|
|
Tumor Growth Rate as Measured by Prostate-specific Antigen (PSA) Rise After 6 Months When PROSTVAC is Initiated Compared to a Group on Surveillance for 6 Months
|
-2.528 Unitless
|
-2.449 Unitless
|
—
|
—
|
SECONDARY outcome
Timeframe: After the participants in the Arm/Group "B/ Delayed PROSTVAC Treatment" received treatment for 6 months after their 6 month surveillance (e.g., 12 months total).Population: 33/40 were evaluable in the first group.
Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
Outcome measures
| Measure |
A/PROSTVAC Treatment
n=33 Participants
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=40 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 1
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 29
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|---|---|
|
Effects of Vaccine on Prostate-specific Antigen (PSA) Growth Rate When PROSTVAC is Initiated After 6 Months on Surveillance
|
-2.513 Unitless
|
-2.449 Unitless
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 35/40 and 32/40 participants are reported because these are the numbers of participants with sufficient samples for analysis.
Normal PSA is 0 nanograms per milliliter (ng/mL). Above 0 ng/mL is considered an increase in tumor growth.
Outcome measures
| Measure |
A/PROSTVAC Treatment
n=35 Participants
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=32 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 1
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 29
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|---|---|
|
Number of Participants With Prostate-specific Antigen (PSA) Specific T-Cells at Baseline and 6 Months
Baseline
|
22 Participants
|
20 Participants
|
—
|
—
|
|
Number of Participants With Prostate-specific Antigen (PSA) Specific T-Cells at Baseline and 6 Months
6 Months
|
14 Participants
|
11 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
A/PROSTVAC Treatment
n=40 Participants
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=40 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 1
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 29
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
40 Participants
|
39 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 29 (Post vaccination) vs Pre (Baseline)Population: 7/40 and 29/40 participants were evaluable in the first and second group, respectively, based on availability of peripheral blood mononuclear cells (PBMCs) before and after vaccination.
Blood samples collected were analyzed by multicolor flow cytometry in PBMCs for refined subsets of Monocytes. Changes in levels of PBMC subsets was a descriptive result with median percent change and interquartile range reported. P values were calculated using the Mann Whitney Test.
Outcome measures
| Measure |
A/PROSTVAC Treatment
n=7 Participants
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=29 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 1
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 29
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|---|---|
|
Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Refined Subsets Monocyte Nonclassical, Monocyte Nonclassical Programmed Death Ligand 1 (PD-L1+), and Monocyte PD-1+ After PROSTVAC
Monocyte Nonclassical Refined Subset
|
-29.8 Percent change
Interval -70.8 to 10.0
|
9.3 Percent change
Interval -26.6 to 41.4
|
—
|
—
|
|
Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Refined Subsets Monocyte Nonclassical, Monocyte Nonclassical Programmed Death Ligand 1 (PD-L1+), and Monocyte PD-1+ After PROSTVAC
Monocyte Nonclassical PD-L1+ Refined Subset
|
-57.5 Percent change
Interval -73.7 to -2.8
|
17.3 Percent change
Interval -15.1 to 56.5
|
—
|
—
|
|
Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Refined Subsets Monocyte Nonclassical, Monocyte Nonclassical Programmed Death Ligand 1 (PD-L1+), and Monocyte PD-1+ After PROSTVAC
Monocyte PD-1+ Refined Subset
|
-55.7 Percent change
Interval -73.1 to -8.2
|
-17.2 Percent change
Interval -38.8 to 15.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 29 (Post vaccination) vs Pre (Baseline)Population: 7/40 and 29/40 participants were evaluable in the first and second group, respectively, based on availability of peripheral blood mononuclear cells (PBMCs) before and after vaccination.
Blood samples collected were analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), myeloid-derived suppressor cell (MDSC) and Tregs. P values were calculated using the Mann Whitney Test.
Outcome measures
| Measure |
A/PROSTVAC Treatment
n=7 Participants
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=29 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 1
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 29
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|---|---|
|
Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC) After PROSTVAC
Classic Subset CD4
|
-7.1 Percent change
Interval -51.7 to 13.0
|
-3.3 Percent change
Interval -13.4 to 11.2
|
—
|
—
|
|
Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC) After PROSTVAC
Classic Subset CD8
|
1.2 Percent change
Interval -16.9 to 51.8
|
2.8 Percent change
Interval -12.0 to 15.2
|
—
|
—
|
|
Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC) After PROSTVAC
Classic Subset Treg
|
44.7 Percent change
Interval -24.8 to 54.2
|
0.7 Percent change
Interval -23.7 to 46.2
|
—
|
—
|
|
Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC) After PROSTVAC
Classic Subset NK
|
26.2 Percent change
Interval -8.7 to 72.0
|
24.1 Percent change
Interval -1.7 to 51.7
|
—
|
—
|
|
Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC) After PROSTVAC
Classic Subset MDSC
|
39.5 Percent change
Interval -67.6 to 680.1
|
20.9 Percent change
Interval -12.6 to 118.5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and one month (Day 29) after vaccine or surveillance (in the Delayed PROSTVAC group)Population: 36 and 12participants were evaluable in the first and second group, respectively, based on availability of peripheral blood mononuclear cells (PBMCs) before and after vaccination or surveillance (in the Delayed PROSTVAC group).
Blood samples collected were analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), myeloid-derived suppressor cell (MDSC), Tregs, and naïve CD4 and naïve CD8 T cells. P values were calculated using the Wilcoxon signed rank test.
Outcome measures
| Measure |
A/PROSTVAC Treatment
n=36 Participants
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=36 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 1
n=12 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment Day 29
n=12 Participants
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|---|---|
|
Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC), and naïve CD4 and CD8 T Cells After PROSTVAC
CD4
|
29.83 Percentage of PBMC
Interval 25.04 to 39.98
|
29.16 Percentage of PBMC
Interval 23.69 to 35.07
|
32.44 Percentage of PBMC
Interval 27.37 to 34.72
|
29.07 Percentage of PBMC
Interval 26.86 to 36.25
|
|
Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC), and naïve CD4 and CD8 T Cells After PROSTVAC
CD8
|
8.87 Percentage of PBMC
Interval 6.97 to 13.34
|
9.98 Percentage of PBMC
Interval 6.96 to 15.28
|
12.71 Percentage of PBMC
Interval 8.78 to 18.54
|
13.00 Percentage of PBMC
Interval 8.65 to 18.55
|
|
Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC), and naïve CD4 and CD8 T Cells After PROSTVAC
Treg
|
0.58 Percentage of PBMC
Interval 0.39 to 0.82
|
0.59 Percentage of PBMC
Interval 0.49 to 0.96
|
1.03 Percentage of PBMC
Interval 0.76 to 1.25
|
0.99 Percentage of PBMC
Interval 0.67 to 1.25
|
|
Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC), and naïve CD4 and CD8 T Cells After PROSTVAC
NK
|
8.04 Percentage of PBMC
Interval 5.64 to 9.08
|
9.28 Percentage of PBMC
Interval 5.79 to 14.39
|
10.35 Percentage of PBMC
Interval 5.82 to 16.03
|
10.17 Percentage of PBMC
Interval 6.18 to 15.93
|
|
Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC), and naïve CD4 and CD8 T Cells After PROSTVAC
MDSC
|
4.60 Percentage of PBMC
Interval 1.83 to 8.75
|
6.02 Percentage of PBMC
Interval 3.19 to 9.0
|
5.74 Percentage of PBMC
Interval 2.42 to 7.28
|
5.52 Percentage of PBMC
Interval 3.06 to 7.32
|
|
Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC), and naïve CD4 and CD8 T Cells After PROSTVAC
Naive CD4
|
7.23 Percentage of PBMC
Interval 3.11 to 10.13
|
6.93 Percentage of PBMC
Interval 2.77 to 12.07
|
7.44 Percentage of PBMC
Interval 2.93 to 11.27
|
7.12 Percentage of PBMC
Interval 3.58 to 9.09
|
|
Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC), and naïve CD4 and CD8 T Cells After PROSTVAC
Naïve CD8
|
1.51 Percentage of PBMC
Interval 0.81 to 2.72
|
1.26 Percentage of PBMC
Interval 0.83 to 2.71
|
1.54 Percentage of PBMC
Interval 0.6 to 3.84
|
1.39 Percentage of PBMC
Interval 0.77 to 3.39
|
Adverse Events
A/PROSTVAC Treatment
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
B/ Delayed PROSTVAC Treatment
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A/PROSTVAC Treatment
n=40 participants at risk
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=40 participants at risk
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Cardiac disorders
Chest pain - cardiac
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Creatinine increased
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Fever
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Infections and infestations - Other, Viral Myocarditis
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Nervous system disorders
Stroke
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
Other adverse events
| Measure |
A/PROSTVAC Treatment
n=40 participants at risk
PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
B/ Delayed PROSTVAC Treatment
n=40 participants at risk
Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients
PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
4/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Psychiatric disorders
Aspartate aminotransferase increased
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
CPK increased
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Chills
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
7.5%
3/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Creatinine increased
|
5.0%
2/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Cystitis noninfective
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Psychiatric disorders
Depression
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
10.0%
4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
2/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Dysuria
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Edema face
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Edema limbs
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Fatigue
|
27.5%
11/40 • Number of events 13 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
40.0%
16/40 • Number of events 19 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Fever
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Eye disorders
Flashing lights
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Eye disorders
Floaters
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Flu like symptoms
|
15.0%
6/40 • Number of events 8 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
15.0%
6/40 • Number of events 10 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Gum infection
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Headache
|
7.5%
3/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
12.5%
5/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Hematuria
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
10.0%
4/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Eye disorders
Hemorrhagic episode of left eye
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.0%
6/40 • Number of events 9 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 7 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Vascular disorders
Hypertension
|
27.5%
11/40 • Number of events 12 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
22.5%
9/40 • Number of events 18 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
8/40 • Number of events 12 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Infusion related reaction
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Injection site reaction
|
72.5%
29/40 • Number of events 119 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
82.5%
33/40 • Number of events 85 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Psychiatric disorders
Insomnia
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Lip infection
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Lymphocyte count decreased
|
5.0%
2/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Malaise
|
10.0%
4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
4/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
5/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
10.0%
4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
General disorders
Pain
|
22.5%
9/40 • Number of events 10 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
17.5%
7/40 • Number of events 8 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Musculoskeletal and connective tissue disorders
Pain in left heel
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Nervous system disorders
Paresthesia
|
2.5%
1/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
10.0%
4/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Cardiac disorders
Sinus bradycardia
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Cardiac disorders
Sinus tachycardia
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
7.5%
3/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Reproductive system and breast disorders
Testicular disorder
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Tooth infection
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Upper respiratory infection
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
2/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Urinary tract pain
|
7.5%
3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Renal and urinary disorders
Urinary urgency
|
2.5%
1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
10.0%
4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Weight gain
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
2.5%
1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
Weight loss
|
5.0%
2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
0.00%
0/40 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
|
Investigations
White blood cell decreased
|
2.5%
1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
5.0%
2/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place