Trial Outcomes & Findings for MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial (NCT NCT01411345)
NCT ID: NCT01411345
Last Updated: 2025-04-08
Results Overview
Prostate-Specific Antigen (PSA) response rate is defined as the percentage of study patients with PSA less than 0.1 ng/mL at 21 months after completion of study treatment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Up to 23 months
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Arm I: Standard Salvage Radiation Treatment (SSRT)
Patients will receive a total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
this arm is closed
Standard Salvage Radiation Treatment (SSRT): A total dose of 68 Gy delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
|
Arm II: Mapped Tumor Salvage RT (MTSRT)
Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
this arm was continues as single arm phase 2
Mapped Tumor Salvage RT (MTSRT): Dose escalation to the imaging or Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
22
|
|
Overall Study
COMPLETED
|
15
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
Baseline characteristics by cohort
| Measure |
Arm I: Standard Salvage Radiation Treatment (SSRT)
n=15 Participants
Patients will receive a total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
this arm is closed
Standard Salvage Radiation Treatment (SSRT): A total dose of 68 Gy delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
|
Arm II: Mapped Tumor Salvage RT (MTSRT)
n=22 Participants
Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
this arm was continues as single arm phase 2
Mapped Tumor Salvage RT (MTSRT): Dose escalation to the imaging or Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 23 monthsPopulation: Participants that completed a PSA evaluation at 21 months after completion of study treatment.
Prostate-Specific Antigen (PSA) response rate is defined as the percentage of study patients with PSA less than 0.1 ng/mL at 21 months after completion of study treatment.
Outcome measures
| Measure |
Arm I: Standard Salvage Radiation Treatment (SSRT)
n=15 Participants
Patients will receive a total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
this arm is closed
Standard Salvage Radiation Treatment (SSRT): A total dose of 68 Gy delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
|
Arm II: Mapped Tumor Salvage RT (MTSRT)
n=20 Participants
Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
this arm was continues as single arm phase 2
Mapped Tumor Salvage RT (MTSRT): Dose escalation to the imaging or Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
PSA Response Rate
|
66.6 percentage of participants
|
85 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 8 monthsIncidence of treatment-emergent toxicity in study participants. Toxicity is defined as adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs)Acute toxicity is defined as toxicity occurring during treatment and within three months of completing treatment. Late toxicity is toxicity occurring more than three months after treatment completion. Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 65 monthsHealth-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 65 monthsHealth-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 65 monthsHealth-related quality of life (HRQOL) will be measured using the International Prostate Symptom Score (IPSS) to evaluate patient urinary function and quality of life. There are 7 questions related to urinary function. Responses are on a scale from 0 ("not at all") to 5 ("almost always"), with higher scores indicating higher levels of urinary dysfunction. There is 1 quality of life question related to urinary symptoms. Responses are on a scale from 0 ("delighted") to 6 ("terrible").
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 65 monthsThe cumulative incidence of biochemical or clinical failure allowing for competing risk as needed. Clinical failure is defined as at least a 25% increase in the size of the tumor relative to the smallest volume recorded, or new extension of tumor beyond the capsule, or re-extension of tumor beyond the capsule after initial regression, or urinary obstructive symptoms with carcinoma found at transurethral resection of the prostate (TURP). Biochemical failure is defined as PSA ≥ nadir + 2 ng/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 65 monthsRate of failure-free survival in study participants. Failure-free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 65 monthsRate of overall survival in study participants. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 65 monthsThe distribution and degree of expression of tissue biomarkers by ultrasound-directed biopsies for patients who choose to undergo the optional biopsies. Quantification of the amount of the biomarker specific immunohistochemical staining in the area of tumor.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 65 monthsTo determine the incidence and relationship of circulating DNA and tumor cells to tissue biomarkers and initial complete biochemical response.
Outcome measures
Outcome data not reported
Adverse Events
Arm I: Standard Salvage Radiation Treatment (SSRT)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 1 deaths
Arm II: Mapped Tumor Salvage RT (MTSRT)
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Standard Salvage Radiation Treatment (SSRT)
n=15 participants at risk
Patients will receive a total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
this arm is closed
Standard Salvage Radiation Treatment (SSRT): A total dose of 68 Gy delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
|
Arm II: Mapped Tumor Salvage RT (MTSRT)
n=22 participants at risk
Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
this arm was continues as single arm phase 2
Mapped Tumor Salvage RT (MTSRT): Dose escalation to the imaging or Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Cardiac disorders
Cardiac Disorders, Other
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
Other adverse events
| Measure |
Arm I: Standard Salvage Radiation Treatment (SSRT)
n=15 participants at risk
Patients will receive a total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
this arm is closed
Standard Salvage Radiation Treatment (SSRT): A total dose of 68 Gy delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
|
Arm II: Mapped Tumor Salvage RT (MTSRT)
n=22 participants at risk
Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
this arm was continues as single arm phase 2
Mapped Tumor Salvage RT (MTSRT): Dose escalation to the imaging or Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • 12 years
|
9.1%
2/22 • Number of events 2 • 12 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • 12 years
|
9.1%
2/22 • Number of events 4 • 12 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/15 • 12 years
|
9.1%
2/22 • Number of events 2 • 12 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/15 • 12 years
|
9.1%
2/22 • Number of events 3 • 12 years
|
|
Gastrointestinal disorders
Anal pain
|
6.7%
1/15 • Number of events 1 • 12 years
|
0.00%
0/22 • 12 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • 12 years
|
9.1%
2/22 • Number of events 2 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • 12 years
|
9.1%
2/22 • Number of events 4 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Cardiac disorders
Cardiac disorders - Other
|
6.7%
1/15 • Number of events 1 • 12 years
|
0.00%
0/22 • 12 years
|
|
General disorders
Chills
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • 12 years
|
9.1%
2/22 • Number of events 2 • 12 years
|
|
Investigations
Creatinine increased
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
20.0%
3/15 • Number of events 3 • 12 years
|
45.5%
10/22 • Number of events 16 • 12 years
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 2 • 12 years
|
0.00%
0/22 • 12 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
6/15 • Number of events 7 • 12 years
|
22.7%
5/22 • Number of events 5 • 12 years
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/15 • 12 years
|
13.6%
3/22 • Number of events 3 • 12 years
|
|
General disorders
Fatigue
|
86.7%
13/15 • Number of events 16 • 12 years
|
59.1%
13/22 • Number of events 16 • 12 years
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • 12 years
|
9.1%
2/22 • Number of events 3 • 12 years
|
|
Renal and urinary disorders
Hematuria
|
33.3%
5/15 • Number of events 8 • 12 years
|
45.5%
10/22 • Number of events 20 • 12 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 2 • 12 years
|
|
Vascular disorders
Hot flashes
|
13.3%
2/15 • Number of events 2 • 12 years
|
31.8%
7/22 • Number of events 7 • 12 years
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • 12 years
|
0.00%
0/22 • 12 years
|
|
Investigations
Investigations - Other
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 2 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • 12 years
|
9.1%
2/22 • Number of events 2 • 12 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15 • Number of events 5 • 12 years
|
18.2%
4/22 • Number of events 5 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • 12 years
|
0.00%
0/22 • 12 years
|
|
Infections and infestations
Penile infection
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 2 • 12 years
|
|
Reproductive system and breast disorders
Penile pain
|
13.3%
2/15 • Number of events 2 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Proctitis
|
6.7%
1/15 • Number of events 1 • 12 years
|
0.00%
0/22 • 12 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Gastrointestinal disorders
Rectal pain
|
6.7%
1/15 • Number of events 1 • 12 years
|
0.00%
0/22 • 12 years
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Reproductive system and breast disorders
Testicular disorder
|
20.0%
3/15 • Number of events 3 • 12 years
|
54.5%
12/22 • Number of events 13 • 12 years
|
|
Reproductive system and breast disorders
Testicular pain
|
6.7%
1/15 • Number of events 1 • 12 years
|
0.00%
0/22 • 12 years
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Renal and urinary disorders
Urinary frequency
|
46.7%
7/15 • Number of events 12 • 12 years
|
31.8%
7/22 • Number of events 11 • 12 years
|
|
Renal and urinary disorders
Urinary incontinence
|
40.0%
6/15 • Number of events 8 • 12 years
|
36.4%
8/22 • Number of events 12 • 12 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • 12 years
|
9.1%
2/22 • Number of events 3 • 12 years
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.7%
1/15 • Number of events 2 • 12 years
|
9.1%
2/22 • Number of events 2 • 12 years
|
|
Renal and urinary disorders
Urinary tract pain
|
20.0%
3/15 • Number of events 4 • 12 years
|
0.00%
0/22 • 12 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/15 • 12 years
|
4.5%
1/22 • Number of events 1 • 12 years
|
|
Investigations
Weight gain
|
6.7%
1/15 • Number of events 1 • 12 years
|
0.00%
0/22 • 12 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/15 • 12 years
|
13.6%
3/22 • Number of events 6 • 12 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place