Trial Outcomes & Findings for Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy (NCT NCT00528866)
NCT ID: NCT00528866
Last Updated: 2019-04-24
Results Overview
Failure was defined as PSA ≥ 0.4 ng/mL after the end of radiation therapy confirmed by a second higher PSA, non-protocol hormones, local-regional progression, distant metastasis, or death, within 3 years after study registration. Freedom from progression (FFP) rate under null hypothesis was 50%; under alternative hypothesis ≥ 70%. Per Fleming's multiple testing procedure with 3 stages, 69 patients (76 allowing for 10% ineligible) were required for 90% power and type I error 0.025. If ≥ 44 of 69 patients had a FFP event, we would reject 50% FFP rate in favor of ≥ 70%. Analysis was out of 74 patients (not 69), so ≥ 44 was revised to ≥ 46.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
From registration to 3 years.
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Androgen Suppression + RT + Docetaxel
Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Androgen Suppression + RT + Docetaxel
Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Overall Study
Protocol Violation
|
6
|
Baseline Characteristics
Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From registration to 3 years.Population: All eligible patients who started study treatment
Failure was defined as PSA ≥ 0.4 ng/mL after the end of radiation therapy confirmed by a second higher PSA, non-protocol hormones, local-regional progression, distant metastasis, or death, within 3 years after study registration. Freedom from progression (FFP) rate under null hypothesis was 50%; under alternative hypothesis ≥ 70%. Per Fleming's multiple testing procedure with 3 stages, 69 patients (76 allowing for 10% ineligible) were required for 90% power and type I error 0.025. If ≥ 44 of 69 patients had a FFP event, we would reject 50% FFP rate in favor of ≥ 70%. Analysis was out of 74 patients (not 69), so ≥ 44 was revised to ≥ 46.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Number of Participants Free From Progression at 3 Years
|
54 participants
|
SECONDARY outcome
Timeframe: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)Population: All eligible patients who started study treatment
Time from registration to date of local progression (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Local-regional Progression (3 Year Rate)
|
0 percentage of participants
A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
|
SECONDARY outcome
Timeframe: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)Population: All eligible patients who started study treatment
Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Distant Metastasis (3-year Rate)
|
6.8 percentage of participants
Interval 2.5 to 14.0
|
SECONDARY outcome
Timeframe: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)Population: All eligible patients who started study treatment
Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Prostate Cancer Death (3-year Rate)
|
0 percentage of participants
A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
|
SECONDARY outcome
Timeframe: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)Population: All eligible patients who started study treatment
Time from registration to date of death due to other causes (failure), death due to prostate cancer (competing risk), or last follow-up (censored).Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Non-prostate Cancer Death (3-year Rate)
|
1.4 percentage of participants
Interval 0.1 to 6.5
|
SECONDARY outcome
Timeframe: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)Population: All eligible patients who started study treatment
Time from registration to date of death (failure) or last follow-up (censored). Three-year rate and 95% confidence interval were estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Overall Survival (3-year Rate)
|
98.6 percentage of participants
Interval 96.0 to 100.0
|
SECONDARY outcome
Timeframe: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)Population: All eligible patients who started study treatment
Failure is defined as PSA ≥ 0.4 ng/mL confirmed by a second higher PSA or initiation of non-protocol hormones. Death is considered a competing risk. Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Time to Biochemical (PSA) Failure (3-year Rate)
|
25.7 percentage of participants
Interval 16.3 to 36.1
|
SECONDARY outcome
Timeframe: From start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed until death or study termination whichever occurs first.Population: All eligible patients who started study treatment
The number of patients with at least one grade 3 or higher adverse event (AE) from start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Number of Patients With "Acute" Adverse Events (Based on CTCAE, v3.0)
|
57 participants
|
SECONDARY outcome
Timeframe: From 91 to 730 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed from registration to death or study termination whichever occurs first.)Population: All eligible patients who started study treatment
Two-year rate shown (cumulative incidence method). Adverse events are graded using CTCAE v3.0. Time of first late adverse event occurrence of the Grade 3+ adverse event between 91 days and 730 days from the completion of treatment (3 weeks after the last planned docetaxel dose) calculated. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 Participants
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Time to "Late" Grade 3+ Adverse Events (Based on CTCAE, v3.0)
|
8.1 percentage of participants
Interval 3.3 to 15.8
|
SECONDARY outcome
Timeframe: Analysis can occur at the same time as the primary endpoint if data is available.Population: The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
Outcome measures
Outcome data not reported
Adverse Events
Androgen Suppression + RT + Docetaxel
Serious events: 20 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 participants at risk
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
2/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
2.7%
2/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chills
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Sinusitis [with normal or Grade 1-2 ANC]
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Creatinine increased
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count decreased
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Ureteric obstruction
|
2.7%
2/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Androgen Suppression + RT + Docetaxel
n=74 participants at risk
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
79.7%
59/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Watering eyes
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
44.6%
33/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
68.9%
51/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.5%
10/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Fecal incontinence
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Flatulence
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
12.2%
9/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Mucositis oral
|
17.6%
13/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
45.9%
34/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctitis
|
16.2%
12/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal pain
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
16.2%
12/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chills
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema limbs
|
47.3%
35/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
94.6%
70/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fever
|
13.5%
10/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
General symptom
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Localized edema [trunk/genital]
|
10.8%
8/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain [NOS]
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain [other]
|
14.9%
11/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
13.5%
10/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
14.9%
11/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Creatinine increased
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Laboratory test abnormal
|
12.2%
9/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia
|
54.1%
40/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
31.1%
23/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count decreased
|
59.5%
44/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
21.6%
16/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight gain
|
16.2%
12/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight loss
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.3%
15/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
52.7%
39/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.9%
14/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.3%
15/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.3%
15/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
33.8%
25/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
10.8%
8/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.6%
16/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
18.9%
14/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
14.9%
11/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
10.8%
8/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.2%
49/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Taste alteration
|
39.2%
29/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Agitation
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
10.8%
8/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
16.2%
12/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
25.7%
19/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Libido decreased
|
13.5%
10/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Bladder pain
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Cystitis
|
17.6%
13/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urethral pain
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
75.7%
56/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
56.8%
42/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
10.8%
8/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urogenital disorder
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
51.4%
38/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Gynecomastia
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
12/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.8%
25/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
63.5%
47/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.6%
13/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
9.5%
7/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
27.0%
20/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
6/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
14.9%
11/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
13.5%
10/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.8%
5/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Flushing
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hot flashes
|
68.9%
51/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypertension
|
5.4%
4/74
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER