Trial Outcomes & Findings for Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer (NCT NCT01717053)
NCT ID: NCT01717053
Last Updated: 2022-10-10
Results Overview
The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of \<0.1 ng/mL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
1 year
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
Abiraterone+Radiotherapy+ADT
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Abiraterone+Radiotherapy+ADT
n=37 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 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
|
PRIMARY outcome
Timeframe: 1 yearPopulation: This analysis includes all patients that completed protocol therapy.
The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of \<0.1 ng/mL.
Outcome measures
| Measure |
Abiraterone+Radiotherapy+ADT
n=33 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
|
54.54 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: This analysis includes all patients that completed protocol therapy.
The median time in months to the lowest PSA value from the start of study therapy.
Outcome measures
| Measure |
Abiraterone+Radiotherapy+ADT
n=33 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Time to PSA Nadir
|
8.9 months
Interval 2.9 to 39.3
|
SECONDARY outcome
Timeframe: 1 year, 2 yearsPopulation: This analysis includes all patients that completed protocol therapy.
The lowest PSA value from the start of study therapy.
Outcome measures
| Measure |
Abiraterone+Radiotherapy+ADT
n=33 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
PSA Nadir Value
Year 1
|
0.03 ng/mL
Interval 0.0 to 0.44
|
|
PSA Nadir Value
Year 2
|
0.03 ng/mL
Interval 0.0 to 0.36
|
SECONDARY outcome
Timeframe: 36 and 48 monthsPopulation: Men with unfavorable prostate cancer (defined as having a single high risk factor)
Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.
Outcome measures
| Measure |
Abiraterone+Radiotherapy+ADT
n=33 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Percentage of Participants With Biochemical Progression-free Survival (BPFS)
36 months
|
96.96 percentage of participants
|
|
Percentage of Participants With Biochemical Progression-free Survival (BPFS)
48 months
|
96.96 percentage of participants
|
SECONDARY outcome
Timeframe: up to 5 years (60 months)Population: Men with unfavorable prostate cancer (defined ad having a single high risk factor)
Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.
Outcome measures
| Measure |
Abiraterone+Radiotherapy+ADT
n=33 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Metastasis or Systemic Therapy
|
60 months
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Men with unfavorable prostate cancer (defined ad having a single high risk factor)
Time to testosterone recovery
Outcome measures
| Measure |
Abiraterone+Radiotherapy+ADT
n=37 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Testosterone Recovery
|
9.2 months
Interval 9.0 to 12.3
|
SECONDARY outcome
Timeframe: 1 year, 2 years, 3 years, 4 years, 5 yearsPopulation: Men with unfavorable prostate cancer (defined as having a single high risk factor)
Percentage of men with 1, 2, 3, 4 and 5 year PSA \< 1.5ng/ml in setting of non-castrate testosterone.
Outcome measures
| Measure |
Abiraterone+Radiotherapy+ADT
n=33 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
1 year
|
100 percentage of patients
|
|
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
2 years
|
100 percentage of patients
|
|
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
3 years
|
90.91 percentage of patients
|
|
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
4 years
|
90.91 percentage of patients
|
|
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
5 years
|
90.91 percentage of patients
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This analysis includes all patients that completed protocol therapy.
The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.
Outcome measures
| Measure |
Abiraterone+Radiotherapy+ADT
n=33 Participants
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Safety and Tolerability
|
12 Participants
|
Adverse Events
Abiraterone+Radiotherapy+ADT
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abiraterone+Radiotherapy+ADT
n=37 participants at risk
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
General disorders
Fever
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
1/37 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, specify: Malignant melanoma
|
2.7%
1/37 • 6 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
1/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Bilateral pleural effusion
|
2.7%
1/37 • 6 months
|
Other adverse events
| Measure |
Abiraterone+Radiotherapy+ADT
n=37 participants at risk
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
|
|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
8.1%
3/37 • 6 months
|
|
Gastrointestinal disorders
Esophageal pain
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.4%
2/37 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Bowel urgency
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Guaiac positive stools
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Intermittent ""mucous loose stool""
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Pt reports intermittent frank red blood on stool
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: diverticulitis
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: intermittent rectal bleeding
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: urgency with bowels
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Gingival pain
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.4%
2/37 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
10.8%
4/37 • 6 months
|
|
Gastrointestinal disorders
Oral pain
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Rectal pain
|
10.8%
4/37 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • 6 months
|
|
General disorders
Edema limbs
|
5.4%
2/37 • 6 months
|
|
General disorders
Fatigue
|
64.9%
24/37 • 6 months
|
|
General disorders
General disorders and administration site conditions - Other, specify: Injury left hand
|
2.7%
1/37 • 6 months
|
|
General disorders
General disorders and administration site conditions - Other, specify: Occasional cramping
|
2.7%
1/37 • 6 months
|
|
General disorders
General disorders and administration site conditions - Other, specify: Perineal pain
|
2.7%
1/37 • 6 months
|
|
General disorders
Injection site reaction
|
2.7%
1/37 • 6 months
|
|
General disorders
Irritability
|
8.1%
3/37 • 6 months
|
|
General disorders
Neck edema
|
2.7%
1/37 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
2.7%
1/37 • 6 months
|
|
General disorders
Pain
|
10.8%
4/37 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify: C diff colitis
|
2.7%
1/37 • 6 months
|
|
Infections and infestations
Tooth infection
|
2.7%
1/37 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
5.4%
2/37 • 6 months
|
|
Injury, poisoning and procedural complications
Burn
|
2.7%
1/37 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
1/37 • 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify:Chigger bite
|
2.7%
1/37 • 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify: Injury to Right Shin
|
2.7%
1/37 • 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify: face injury
|
2.7%
1/37 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
32.4%
12/37 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
8.1%
3/37 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
35.1%
13/37 • 6 months
|
|
Investigations
Blood bilirubin increased
|
8.1%
3/37 • 6 months
|
|
Investigations
Creatinine increased
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Blood Urea Nitrogen 20(7-18); 20 (8-20)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Blood Urea Nitrogen 21 (8-20)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Blood Urea Nitrogen 23 (7-18); 20 (8-20)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Blood urea nitrogen 28;18
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: CO2 level (carbon dioxide) 31
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: CO2 level (carbon dioxide)31
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: CO2 level (carbon dioxide)31 (23-30)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Decreased ALT, <12 (7-56)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Elevated CO2 (Carbon Dioxide) level at 31 (23-30)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Elevated Total Bilirubin
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Elevated Total Bilirubin, decreased at 1.5
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Increased Albumin 5.0 (3.5-4.7)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Increased CO2 (carbon dioxide) level, 31
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Low Chloride 96 (98-108)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Low Chloride 97;on 3/31- 96 (98-108)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Low serum creatinine, 0.66
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Minimally increased @ 32 (23-30)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Serum Carbon Dioxide Level 32;28 (23-30)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Serum Carbon Dioxide Level 34;29 (23-30)
|
2.7%
1/37 • 6 months
|
|
Investigations
Investigations - Other, specify: Weight loss, 83.7 kg (88 kg on 6/4/15)
|
2.7%
1/37 • 6 months
|
|
Investigations
Platelet count decreased
|
2.7%
1/37 • 6 months
|
|
Investigations
Urine output decreased
|
2.7%
1/37 • 6 months
|
|
Investigations
Weight gain
|
2.7%
1/37 • 6 months
|
|
Investigations
Weight loss
|
5.4%
2/37 • 6 months
|
|
Investigations
White blood cell decreased
|
2.7%
1/37 • 6 months
|
|
Metabolism and nutrition disorders
Acidosis
|
2.7%
1/37 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
2/37 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.6%
8/37 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.7%
1/37 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.7%
1/37 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.6%
8/37 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
13.5%
5/37 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
27.0%
10/37 • 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
13.5%
5/37 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
10.8%
4/37 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
1/37 • 6 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Irregular heart beats
|
2.7%
1/37 • 6 months
|
|
Cardiac disorders
Chest pain - cardiac
|
2.7%
1/37 • 6 months
|
|
Cardiac disorders
Palpitations
|
2.7%
1/37 • 6 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: ""slight off balance and fluid in ears""
|
2.7%
1/37 • 6 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: Slight off balance
|
2.7%
1/37 • 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
2.7%
1/37 • 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
2.7%
1/37 • 6 months
|
|
Eye disorders
Blurred vision
|
5.4%
2/37 • 6 months
|
|
Eye disorders
Dry eye
|
2.7%
1/37 • 6 months
|
|
Eye disorders
Eye disorders - Other, specify: Left eye ""stye with morning crustiness""
|
2.7%
1/37 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.1%
3/37 • 6 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: Possible mineralcorticoid excess (hypokalemia)
|
2.7%
1/37 • 6 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: elevated ALT/AST
|
2.7%
1/37 • 6 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: low Total Protein level- 5.8 (6.1-8.1)
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
2/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Chronic left hip/sciatica pain
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Decreased strength & endurance
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: L4-L5 procedure on 8/4/15
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Right Lower Extremity leg spasm
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Right flank pain
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: bursitis, left knee
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: restless legs
|
2.7%
1/37 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
2/37 • 6 months
|
|
Nervous system disorders
Dizziness
|
10.8%
4/37 • 6 months
|
|
Nervous system disorders
Dysgeusia
|
2.7%
1/37 • 6 months
|
|
Nervous system disorders
Headache
|
10.8%
4/37 • 6 months
|
|
Nervous system disorders
Memory impairment
|
5.4%
2/37 • 6 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Chronic sciatic back pain
|
2.7%
1/37 • 6 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Pre-treatment, chronic sciatic back pain
|
2.7%
1/37 • 6 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify: lightheaded, when standing
|
2.7%
1/37 • 6 months
|
|
Nervous system disorders
Paresthesia
|
5.4%
2/37 • 6 months
|
|
Nervous system disorders
Presyncope
|
2.7%
1/37 • 6 months
|
|
Nervous system disorders
Somnolence
|
2.7%
1/37 • 6 months
|
|
Psychiatric disorders
Agitation
|
2.7%
1/37 • 6 months
|
|
Psychiatric disorders
Anxiety
|
2.7%
1/37 • 6 months
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • 6 months
|
|
Psychiatric disorders
Insomnia
|
13.5%
5/37 • 6 months
|
|
Psychiatric disorders
Libido decreased
|
16.2%
6/37 • 6 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.7%
1/37 • 6 months
|
|
Psychiatric disorders
Restlessness
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
10.8%
4/37 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
5.4%
2/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Dysuria
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Increased urination
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Nocturia
|
5.4%
2/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Slow urinary stream
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Urinary hesistancy
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Urinary hesitancy
|
8.1%
3/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Weak urinary stream
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: nocturia
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: weak stream
|
2.7%
1/37 • 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
54.1%
20/37 • 6 months
|
|
Renal and urinary disorders
Urinary incontinence
|
13.5%
5/37 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
5.4%
2/37 • 6 months
|
|
Renal and urinary disorders
Urinary tract pain
|
16.2%
6/37 • 6 months
|
|
Renal and urinary disorders
Urinary urgency
|
13.5%
5/37 • 6 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.1%
3/37 • 6 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
5.4%
2/37 • 6 months
|
|
Reproductive system and breast disorders
Perineal pain
|
2.7%
1/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.5%
5/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.8%
4/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
2.7%
1/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.8%
4/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.7%
1/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
2/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Dry nose
|
2.7%
1/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
2.7%
1/37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.4%
2/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.1%
3/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.4%
2/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
2/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.4%
2/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify:
|
2.7%
1/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Basal cell carcinoma of left ear
|
2.7%
1/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Melanoma of lower back
|
2.7%
1/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Melanoma of right shoulder
|
2.7%
1/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Soft non-tender area on lower leg
|
2.7%
1/37 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: skin pallor, pale
|
2.7%
1/37 • 6 months
|
|
Vascular disorders
Hot flashes
|
75.7%
28/37 • 6 months
|
|
Vascular disorders
Hypertension
|
59.5%
22/37 • 6 months
|
|
Vascular disorders
Vascular disorders - Other, specify: Facial petechiae ""from force of vomiting"" per pt
|
2.7%
1/37 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place