Trial Outcomes & Findings for pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (NCT NCT03600350)
NCT ID: NCT03600350
Last Updated: 2025-05-09
Results Overview
Subjects will be evaluated at each visit by a review of systems based on the most recent version of the NCI common toxicity criteria. Safety and Tolerability of this intervention is defined as following: a toxicity rate p0 of at most 15% of Grade ≥ 3 toxicity events (CTCAE v.4.0) will be considered as acceptable while a toxicity rate p1=35% or more will be considered as unacceptably high. See Adverse Events Section for full summary of data.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
up to 48 weeks
Results posted on
2025-05-09
Participant Flow
Participants were recruited from September 2018 to December 2021.
Participant milestones
| Measure |
Treatment Group
* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.
pTVG-HP: Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
On Treatment
|
19
|
|
Overall Study
Off Treatment
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Treatment Group
* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.
pTVG-HP: Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
On Follow Up
|
18
|
Baseline Characteristics
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment Group
n=19 Participants
* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.
pTVG-HP: Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
|
|---|---|
|
Age, Customized
60-69 years
|
10 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 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
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 48 weeksSubjects will be evaluated at each visit by a review of systems based on the most recent version of the NCI common toxicity criteria. Safety and Tolerability of this intervention is defined as following: a toxicity rate p0 of at most 15% of Grade ≥ 3 toxicity events (CTCAE v.4.0) will be considered as acceptable while a toxicity rate p1=35% or more will be considered as unacceptably high. See Adverse Events Section for full summary of data.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.
pTVG-HP: Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
|
|---|---|
|
Number of Participants Who Experienced Adverse Events Grade 3 or Higher
|
4 Participants
|
PRIMARY outcome
Timeframe: up to 48 weeksA PSA CR will be defined as the percentage of participants with a serum PSA \<0.2 ng/mL and confirmatory PSA \<0.2 ng/mL at least 4 weeks later, as per Prostate Cancer Working Group 2 (PCWG2) recommendations. To qualify as a PSA CR, there must be no evidence of radiographic progression.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.
pTVG-HP: Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
|
|---|---|
|
Prostate-Specific Antigen (PSA) Complete Response (CR) Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe 5-year metastasis-free survival will be determined by investigator review of radiographic studies (CT/MRI and bone scintigraphy) performed 5 years after study initiation in subjects who have not already met criteria for radiographic progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsAll participants will undergo radiographic imaging prior to treatment and at 6-month intervals (or as clinically required). The appearance of lesions consistent with metastatic disease will be used to define radiographic progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPost-treatment doubling time will be calculated from: 1) All PSA values obtained from the same clinical laboratory using the same PSA assay beginning with the PSA value at day 1 (week 0) and continuing until the end-of study (or month 24) value (PSADT 0-24). 2) All PSA values obtained from the same clinical laboratory using the same PSA assay beginning with the PSA value at day 85 (month 3) to the day 253 (month 9) value (PSADT 3-9).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsThe percentage of participants with PSA values less than or equal to their baseline value after 2 year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to week 4GM-CSF is used as an adjuvant if the PSA at week 4 is higher than baseline.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.
pTVG-HP: Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
|
|---|---|
|
Number of Participants Receiving GM-CSF as an Adjuvant After Week 4
|
14 Participants
|
Adverse Events
Treatment Group
Serious events: 5 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment Group
n=19 participants at risk
* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.
pTVG-HP: Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
General disorders
Infusion related reaction
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
Other adverse events
| Measure |
Treatment Group
n=19 participants at risk
* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 \> serum PSA obtained at day 1.
pTVG-HP: Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
|
|---|---|
|
General disorders
Fatigue
|
57.9%
11/19 • Number of events 15 • up to 2 years
|
|
General disorders
Chills
|
31.6%
6/19 • Number of events 10 • up to 2 years
|
|
General disorders
Injection site reaction
|
21.1%
4/19 • Number of events 8 • up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
15.8%
3/19 • Number of events 3 • up to 2 years
|
|
General disorders
Fever
|
10.5%
2/19 • Number of events 5 • up to 2 years
|
|
General disorders
Pain
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
General disorders
Flu like symptoms
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
General disorders
Gait disturbance
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
General disorders
Infusion related reaction
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
31.6%
6/19 • Number of events 10 • up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
21.1%
4/19 • Number of events 8 • up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
21.1%
4/19 • Number of events 5 • up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
21.1%
4/19 • Number of events 4 • up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Investigations
Serum amylase increased
|
21.1%
4/19 • Number of events 5 • up to 2 years
|
|
Investigations
Creatinine increased
|
15.8%
3/19 • Number of events 3 • up to 2 years
|
|
Investigations
Lipase increased
|
10.5%
2/19 • Number of events 8 • up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Investigations
Platelet count decreased
|
10.5%
2/19 • Number of events 3 • up to 2 years
|
|
Investigations
White blood cell decreased
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Investigations
Weight gain
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Investigations
Weight loss
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.1%
4/19 • Number of events 4 • up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.1%
4/19 • Number of events 5 • up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.8%
3/19 • Number of events 3 • up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
1/19 • Number of events 2 • up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.3%
1/19 • Number of events 4 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.3%
5/19 • Number of events 8 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.1%
4/19 • Number of events 5 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.8%
3/19 • Number of events 3 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.5%
2/19 • Number of events 3 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Nervous system disorders
Dizziness
|
21.1%
4/19 • Number of events 5 • up to 2 years
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • Number of events 5 • up to 2 years
|
|
Nervous system disorders
Tremor
|
15.8%
3/19 • Number of events 3 • up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Number of events 3 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.3%
5/19 • Number of events 6 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.1%
4/19 • Number of events 9 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
15.8%
3/19 • Number of events 3 • up to 2 years
|
|
Infections and infestations
Skin infection
|
10.5%
2/19 • Number of events 3 • up to 2 years
|
|
Infections and infestations
Lung infection
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Infections and infestations
Tooth infection
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Vascular disorders
Hypertension
|
26.3%
5/19 • Number of events 9 • up to 2 years
|
|
Vascular disorders
Hot flashes
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
21.1%
4/19 • Number of events 5 • up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
15.8%
3/19 • Number of events 3 • up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Endocrine disorders
Hyperparathyroidism
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
26.3%
5/19 • Number of events 7 • up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • Number of events 2 • up to 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Injury, poisoning and procedural complications
Burn
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Eye disorders
Blurred vision
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Eye disorders
Watering eyes
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Psychiatric disorders
Insomnia
|
10.5%
2/19 • Number of events 2 • up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Renal and urinary disorders
Urinary tract pain
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
5.3%
1/19 • Number of events 1 • up to 2 years
|
Additional Information
Douglas McNeel, MD, PhD
University of Wisconsin Carbone Cancer Center
Phone: (608) 263-4198
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place