Trial Outcomes & Findings for Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139 (NCT NCT02362464)
NCT ID: NCT02362464
Last Updated: 2024-12-10
Results Overview
The number of Grade 3 adverse events probably related to the vaccine treatment. Adverse events were measured using the Common Terminology Criteria for Adverse Events (CTCAE v.4.0). Grade 3 is severe.
COMPLETED
PHASE2
14 participants
Up to 30 days after week 24 vaccination
2024-12-10
Participant Flow
Participant milestones
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Overall Study
Switched to alternative therapy
|
1
|
|
Overall Study
Refused further treatment
|
1
|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139
Baseline characteristics by cohort
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=14 Participants
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
70.14 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after week 24 vaccinationThe number of Grade 3 adverse events probably related to the vaccine treatment. Adverse events were measured using the Common Terminology Criteria for Adverse Events (CTCAE v.4.0). Grade 3 is severe.
Outcome measures
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=14 Participants
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Number of Grade 3 Adverse Events (AEs) Probably Related to the Vaccine Treatment
|
1 Adverse events
|
SECONDARY outcome
Timeframe: Weeks 3-24 minus baseline, and Weeks 3-48 minus baselinePopulation: Study participants who were in biochemically recurrent prostate cancer and not exposed to androgen deprivation therapy for the management of prostate cancer were evaluable for this endpoint.
"PSA slope log" was calculated using Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms (http://nomograms.mskcc.org/Prostate/PsaDoublingTime.aspx) Slope log represents the speed of change of a series of values. Thus, it is reported without any units as it is with a concept of ratio. The clinical meaning of PSA slope change would be decrease or increase of the "speed (velocity)" of changes in PSA, not the changes in PSA values. Decreasing PSA slope after the investigational treatment would mean the PSA rise is slower than pre-treatment baseline. Lowered PSA slope has been reported to show a relationship with was reported as related to improved outcomes.
Outcome measures
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=6 Participants
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Change in Slope Log PSA From Pre-study Baseline (-12 Months to Entry on the Current Study) to the Change in Slope Log PSA at Weeks 3-24 and 3-48 Post Multi-Epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination
Weeks 3-24
|
-0.00 Slope log
Interval -0.09 to 0.1
|
|
Change in Slope Log PSA From Pre-study Baseline (-12 Months to Entry on the Current Study) to the Change in Slope Log PSA at Weeks 3-24 and 3-48 Post Multi-Epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination
Weeks 3-48
|
-0.01 Slope log
Interval -0.04 to 0.08
|
SECONDARY outcome
Timeframe: Weeks 3-24 minus baseline, and Weeks 3-48 minus baselinePopulation: The participants who were evaluable for Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms are reported for this outcome measure.
Participants slope log on study 09C0139 are compared with the slope log values for the same participants after receiving the updated ME-TARP vaccines on the current protocol 15C0076 in participants who were not treated with androgen deprivation. PSA slope log was calculated using Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms (http://nomograms.mskcc.org/Prostate/PsaDoublingTime.aspx) Slope log represents the speed of change of a series of values. Thus, it is reported without any units as it is with a concept of ratio. The clinical meaning of PSA slope change would be decrease or increase of the "speed (velocity)" of changes in PSA, not the changes in PSA values. Decreasing PSA slope after the investigational treatment would mean the PSA rise is slower than pre-treatment baseline. Lowered PSA slope has been reported to show a relationship with was reported as related to improved outcomes.
Outcome measures
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=6 Participants
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Change in Slope Log Prostate Specific-antigen (PSA) Versus the Same Change in Slope Log PSA Parameters Following 1st Generation T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination on Protocol 09-C-0139
PSA slope log of the participants while on previous study 09C0139 at Weeks 3-24
|
-0.06 Slope log
Interval -0.175 to 0.018
|
|
Change in Slope Log Prostate Specific-antigen (PSA) Versus the Same Change in Slope Log PSA Parameters Following 1st Generation T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination on Protocol 09-C-0139
PSA slope log of the participants while on current study 15C0076 at Weeks 3-24
|
-0.00 Slope log
Interval -0.09 to 0.1
|
|
Change in Slope Log Prostate Specific-antigen (PSA) Versus the Same Change in Slope Log PSA Parameters Following 1st Generation T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination on Protocol 09-C-0139
PSA slope log of the participants while on previous study 09C0139 at Weeks 3-48
|
-0.03 Slope log
Interval -0.116 to 0.012
|
|
Change in Slope Log Prostate Specific-antigen (PSA) Versus the Same Change in Slope Log PSA Parameters Following 1st Generation T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination on Protocol 09-C-0139
PSA slope log of the participants while on current study 15C0076 at Weeks 3-48
|
-0.01 Slope log
Interval -0.04 to 0.08
|
SECONDARY outcome
Timeframe: Week 24 and Week 48 following immunization with the 2nd generation Multi-Epitope (ME) TARPPopulation: 13/14 participants were evaluable for this outcome measure. Week 48 was not done due to issues in laboratory resources: samples were available in very limited number of participants and assay was not done (data not collected). As the samples were too low, the cost/resources needed to analyze week 48 were prohibitive funding wise considering the limited information to be generated with a small sample size.
Measure of activity to WT27-35 and EE29-37-9V TARP peptides was done by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISPOT) assay. Positivity was defined by higher counts of spot counts than the counts in negative controls. and reactivity defined by higher spot counts than the negative controls.
Outcome measures
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=13 Participants
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Number of Participants With Reactivity to WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptides
Week 24 Reactive to TARP WT27-35
|
5 Participants
|
|
Number of Participants With Reactivity to WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptides
Week 24 Reactive to TARP EE29-37
|
9 Participants
|
|
Number of Participants With Reactivity to WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptides
Week 24 Reactive to Both Peptides
|
5 Participants
|
|
Number of Participants With Reactivity to WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptides
Week 24 Not Reactive to Any of the Peptides
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 24 and 48 following Multi-Epitope (ME) TARP vaccinationPopulation: 13/14 participants were evaluable for this outcome measure. Week 48 not done due to issues in laboratory resources: Week 48 was not done due to issues in laboratory resources: samples were available in very limited number of participants and assay was not done (data not collected). As the samples were too low, the cost/resources needed to analyze week 48 were prohibitive funding wise considering the limited information to be generated with a small sample size.
Number of participants positive for WT27-35 and EE29-37-9V TARP peptide interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISPOT) reactivity. Positivity was defined by higher counts of spot counts than the counts in negative controls.
Outcome measures
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=13 Participants
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Number of Participants Positive for T-cell Receptor Alternate Reading Frame Protein (TARP) WT27-35 and EE29-37-9V Peptide Reactivity to That of the 1st Generation TARP Vaccine in the Same Individuals on Protocol 09-C-0139 (NCT00972309) and 15-C0076
Week 24 Positive for WT27-35 Peptide in 09C0139
|
7 Participants
|
|
Number of Participants Positive for T-cell Receptor Alternate Reading Frame Protein (TARP) WT27-35 and EE29-37-9V Peptide Reactivity to That of the 1st Generation TARP Vaccine in the Same Individuals on Protocol 09-C-0139 (NCT00972309) and 15-C0076
Week 24 Positive for WT27-35 Peptide in 15C0076
|
6 Participants
|
|
Number of Participants Positive for T-cell Receptor Alternate Reading Frame Protein (TARP) WT27-35 and EE29-37-9V Peptide Reactivity to That of the 1st Generation TARP Vaccine in the Same Individuals on Protocol 09-C-0139 (NCT00972309) and 15-C0076
Week 24 Positive for TARP EE29-37 Peptide in 09C0139
|
8 Participants
|
|
Number of Participants Positive for T-cell Receptor Alternate Reading Frame Protein (TARP) WT27-35 and EE29-37-9V Peptide Reactivity to That of the 1st Generation TARP Vaccine in the Same Individuals on Protocol 09-C-0139 (NCT00972309) and 15-C0076
Week 24 Positive for TARP EE29-37 Peptide in 015C0076
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 82 months and 6 daysHere is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v.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 |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=14 Participants
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v.0)
|
13 Participants
|
Adverse Events
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
Serious adverse events
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=14 participants at risk
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
Other adverse events
| Measure |
Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
n=14 participants at risk
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine: dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, red streak in right arm
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Investigations
Creatinine increased
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Renal and urinary disorders
Cystitis noninfective
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
General disorders
Fatigue
|
21.4%
3/14 • Number of events 5 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
General disorders
Fever
|
7.1%
1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
General disorders
Flu like symptoms
|
7.1%
1/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, tooth chip
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Renal and urinary disorders
Hematuria
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Vascular disorders
Hot flashes
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Vascular disorders
Hypertension
|
14.3%
2/14 • Number of events 6 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
2/14 • Number of events 7 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
General disorders
Injection site reaction
|
92.9%
13/14 • Number of events 127 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Psychiatric disorders
Libido decreased
|
21.4%
3/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
1/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Soft nodule on the right temporal region, non tender
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, chronically dry skin
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, genital herpes lesions
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, lump under right 1st toe nail
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Infections and infestations
Skin infection
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Investigations
Weight gain
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Injury, poisoning and procedural complications
Wound complication
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
|
Infections and infestations
Wound infection
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 82 months and 6 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place