Trial Outcomes & Findings for Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers (NCT NCT02141490)
NCT ID: NCT02141490
Last Updated: 2019-09-06
Results Overview
Visible nodes were quantified with manually contoured regions of interest on axial T2\*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% \* ((SInormal(24hrs)- SInormal(baseline))/ SInormal(baseline)).This image processing method was performed at baseline, 24-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 24 hours post injection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Baseline and 24 hours
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
Prostate Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Bladder Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Kidney Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
6
|
3
|
|
Overall Study
COMPLETED
|
30
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
Prostate Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Bladder Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Kidney Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
|---|---|---|---|
|
Overall Study
Screening failures
|
4
|
0
|
0
|
Baseline Characteristics
Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers
Baseline characteristics by cohort
| Measure |
Prostate Cancer
n=34 Participants
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Bladder Cancer
n=6 Participants
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Kidney Cancer
n=3 Participants
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Total
n=43 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 6.65 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 10.25 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 9.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 hoursPopulation: Results are available for 39/43 subjects because 4 were screen failures.
Visible nodes were quantified with manually contoured regions of interest on axial T2\*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% \* ((SInormal(24hrs)- SInormal(baseline))/ SInormal(baseline)).This image processing method was performed at baseline, 24-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 24 hours post injection.
Outcome measures
| Measure |
All Participants
n=39 Participants
Due to low accrual in the bladder and renal arms, all three diseases (Prostate Cancer, Bladder Cancer and Kidney Cancer) were combined together for analysis.
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Bladder Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Kidney Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
|---|---|---|---|
|
Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes
% change from baseline to 24h in metastatic nodes
|
-33.6 Percentage Change
Interval -39.2 to -28.0
|
—
|
—
|
|
Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes
% change from baseline to 24h in benign nodes
|
-46.9 Percentage Change
Interval -54.8 to -39.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 48 hours post injectionPopulation: Results are available for 39/43 subjects because 4 were screen failures.
Visible nodes were quantified with manually contoured regions of interest on axial T2\*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% \* ((SInormal(48hrs)- SInormal(baseline))/ SInormal(baseline))). This image processing method was performed at baseline, 48-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 48 hours post-injection.
Outcome measures
| Measure |
All Participants
n=39 Participants
Due to low accrual in the bladder and renal arms, all three diseases (Prostate Cancer, Bladder Cancer and Kidney Cancer) were combined together for analysis.
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Bladder Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Kidney Cancer
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
|---|---|---|---|
|
Percentage Change for Imaging (From Baseline to 48 Hours) Between Metastatic and Benign Nodes
% change from baseline to 48h in metastatic nodes
|
-24 Percent Change
Interval -32.2 to -15.8
|
—
|
—
|
|
Percentage Change for Imaging (From Baseline to 48 Hours) Between Metastatic and Benign Nodes
% change from baseline to 48h in benign nodes
|
-40 Percent Change
Interval -51.5 to -28.4
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 24 hours and 48 hoursPopulation: The analysis for this outcome measure was not done because most of the patients had deeply located lymph nodes and logistically ultrasonography analysis was not possible.
Patients will undergo ultrasound examination of imageable lymph nodes at pre-infusion, 24 hours and 48 hours. The signal changes at post-infusion ultrasound will be visually evaluated to determine if the uptake of ferumoxytol alters sonographic features.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, andPopulation: Results are available for 39/43 subjects because 4 were screen failures.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in 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 |
All Participants
n=30 Participants
Due to low accrual in the bladder and renal arms, all three diseases (Prostate Cancer, Bladder Cancer and Kidney Cancer) were combined together for analysis.
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Bladder Cancer
n=6 Participants
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Kidney Cancer
n=3 Participants
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
|---|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
6 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Prostate Cancer
Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths
Bladder Cancer
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Kidney Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prostate Cancer
n=30 participants at risk
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Bladder Cancer
n=6 participants at risk
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
Kidney Cancer
n=3 participants at risk
Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol: 7.5mg/kg intravenous (IV) infusion
Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
|
|---|---|---|---|
|
Vascular disorders
Flushing
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/6 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/3 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/6 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/3 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
|
Nervous system disorders
Nervous system disorders - Other, "Warm feeling"
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/6 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/3 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/6 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/3 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
|
Gastrointestinal disorders
Stomach pain
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/6 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/3 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
|
Investigations
White blood cell decreased
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/3 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/30 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
0.00%
0/3 • Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place