Trial Outcomes & Findings for A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy (NCT NCT01302041)
NCT ID: NCT01302041
Last Updated: 2018-10-02
Results Overview
A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 25 for any reason were treated as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Baseline and Week 25
Results posted on
2018-10-02
Participant Flow
This was a multinational, phase 2, open-label, single-arm, efficacy and safety study of oral enzalutamide in participants with prostate cancer who had noncastrate levels of testosterone at study entry.
Eighty-two participants were assessed for participation in the study, 15 were excluded and 67 were enrolled. Participants who continued to receive clinical benefit as assessed by the investigator and did not meet any treatment discontinuation criteria were eligible to transition to an open-label extension study 9785-CL-0123 (NCT02960022).
Participant milestones
| Measure |
Enzalutamide
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
Treatment Received
|
67
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Enzalutamide
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Other-Transitioned to 9785-CL-0123
|
29
|
|
Overall Study
Other-Miscellaneous Reason
|
2
|
Baseline Characteristics
A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Age, Continuous
|
73.0 Years
n=113 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=113 Participants
|
|
Body Mass Index (BMI)
|
26.17 kg/m²
n=113 Participants
|
|
Prostate Specific Antigen (PSA)
|
18.2 ng/mL
INTER_QUARTILE_RANGE 102.990 • n=113 Participants
|
|
Duration of Prostate Cancer
|
1.0 years
n=113 Participants
|
|
Total Gleason Score at Initial Diagnosis
4
|
1 Participants
n=113 Participants
|
|
Total Gleason Score at Initial Diagnosis
5
|
5 Participants
n=113 Participants
|
|
Total Gleason Score at Initial Diagnosis
6
|
10 Participants
n=113 Participants
|
|
Total Gleason Score at Initial Diagnosis
7
|
34 Participants
n=113 Participants
|
|
Total Gleason Score at Initial Diagnosis
8
|
7 Participants
n=113 Participants
|
|
Total Gleason Score at Initial Diagnosis
9
|
6 Participants
n=113 Participants
|
|
Total Gleason Score at Initial Diagnosis
10
|
3 Participants
n=113 Participants
|
|
Total Gleason Score at Initial Diagnosis
Unknown
|
1 Participants
n=113 Participants
|
|
Clinical Tumor Stage (T) at Initial Diagnosis
TX: Primary tumor cannot be assessed
|
1 Participants
n=113 Participants
|
|
Clinical Tumor Stage (T) at Initial Diagnosis
T0: No evidence of primary tumor
|
1 Participants
n=113 Participants
|
|
Clinical Tumor Stage (T) at Initial Diagnosis
T1: Tumor neither palpable or visible by imaging
|
9 Participants
n=113 Participants
|
|
Clinical Tumor Stage (T) at Initial Diagnosis
T2: Tumor confined within the prostate
|
31 Participants
n=113 Participants
|
|
Clinical Tumor Stage (T) at Initial Diagnosis
T3: Tumor extends through the prostatic capsule
|
18 Participants
n=113 Participants
|
|
Clinical Tumor Stage (T) at Initial Diagnosis
T4: Tumor is fixed or invades adjacent structures
|
1 Participants
n=113 Participants
|
|
Clinical Tumor Stage (T) at Initial Diagnosis
Unknown
|
6 Participants
n=113 Participants
|
|
Clinical Lymph Node Stage (N) at Initial Diagnosis
NX: Regional lymph nodes were not assessed
|
24 Participants
n=113 Participants
|
|
Clinical Lymph Node Stage (N) at Initial Diagnosis
N0: No regional lymph node metastasis
|
22 Participants
n=113 Participants
|
|
Clinical Lymph Node Stage (N) at Initial Diagnosis
N1: Metastasis in regional lymph node(s)
|
6 Participants
n=113 Participants
|
|
Clinical Lymph Node Stage (N) at Initial Diagnosis
Unknown
|
15 Participants
n=113 Participants
|
|
Distant Metastasis (M) at Initial Diagnosis
MX: Distant metastasis could not be assessed
|
11 Participants
n=113 Participants
|
|
Distant Metastasis (M) at Initial Diagnosis
M0: No distant metastasis
|
35 Participants
n=113 Participants
|
|
Distant Metastasis (M) at Initial Diagnosis
M1: Distant metastasis
|
10 Participants
n=113 Participants
|
|
Distant Metastasis (M) at Initial Diagnosis
Unknown
|
11 Participants
n=113 Participants
|
|
Participants With Metastases at Study Entry
|
26 Participants
n=113 Participants
|
|
Number of Metastatic Lesions by Bone Scan
|
1 Lesions
n=113 Participants
|
|
Previous Interventions
Radiotherapy
|
16 Participants
n=113 Participants
|
|
Previous Interventions
Prostatectomy
|
24 Participants
n=113 Participants
|
|
Previous Interventions
Transurethral Resection of the Prostate
|
4 Participants
n=113 Participants
|
|
Previous Interventions
Pelvic Lymph Node Dissection
|
6 Participants
n=113 Participants
|
|
Previous Interventions
Watchful Waiting
|
14 Participants
n=113 Participants
|
|
Previous Interventions
Other Surgeries/Procedures
|
4 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 25Population: The analysis population was safety analysis set (SAF), which consisted of participants who received at least one dose of study drug.
A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 25 for any reason were treated as non-responders.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25
|
92.5 Percentage of Participants
Interval 83.44 to 97.53
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)Population: Safety Analysis Set
Each adverse event (AE) was assessed by the investigator for causal relationship to the study drug; those deemed possibly or probably related to study drug are reported as drug regimen related AEs (DRRAEs). A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: * Resulted in death * Was life-threatening * Resulted in persistent or significant disability/incapacity * Resulted in congenital anomaly or birth defect * Required inpatient hospitalization or led to prolongation of hospitalization * Other medically important events.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Number of Participants With Adverse Events
Any Adverse Events
|
67 Participants
|
|
Number of Participants With Adverse Events
Deaths
|
5 Participants
|
|
Number of Participants With Adverse Events
Drug Regimen Related Adverse Events
|
65 Participants
|
|
Number of Participants With Adverse Events
Serious Adverse Events
|
24 Participants
|
|
Number of Participants With Adverse Events
Drug Regimen Related Serious Adverse Events
|
5 Participants
|
|
Number of Participants With Adverse Events
AEs Leading to Discontinuation of Study Drug
|
14 Participants
|
|
Number of Participants With Adverse Events
DRRAEs Leading to Discontinuation of Study Drug
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study)Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in PSA
Week 25
|
-97.82 Percent Change
Standard Deviation 5.744
|
|
Percent Change From Baseline in PSA
Week 49
|
-98.96 Percent Change
Standard Deviation 2.767
|
|
Percent Change From Baseline in PSA
Week 97
|
-99.44 Percent Change
Standard Deviation 1.114
|
|
Percent Change From Baseline in PSA
Week 169
|
-91.74 Percent Change
Standard Deviation 27.808
|
|
Percent Change From Baseline in PSA
Week 265 (End of Study)
|
-0.70 Percent Change
Standard Deviation 368.253
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)
Week 25
|
100.60 Percent Change
Standard Deviation 49.362
|
|
Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)
Week 49
|
88.45 Percent Change
Standard Deviation 41.911
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Androstenedione
Week 25
|
51.06 Percent Change
Standard Deviation 59.367
|
|
Percent Change From Baseline in Androstenedione
Week 49
|
49.94 Percent Change
Standard Deviation 55.449
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Dehydroepiandrosterone (DHEA)
Week 25
|
9.59 Percent Change
Standard Deviation 58.247
|
|
Percent Change From Baseline in Dehydroepiandrosterone (DHEA)
Week 49
|
10.54 Percent Change
Standard Deviation 54.864
|
SECONDARY outcome
Timeframe: Baseline and Week 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Dihydrotestosterone (DHT)
Week 25
|
51.72 Percent Change
Standard Deviation 57.511
|
|
Percent Change From Baseline in Dihydrotestosterone (DHT)
Week 49
|
74.35 Percent Change
Standard Deviation 101.451
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Estradiol
Week 25
|
71.69 Percent Change
Standard Deviation 73.150
|
|
Percent Change From Baseline in Estradiol
Week 49
|
81.00 Percent Change
Standard Deviation 82.811
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Follicle-Stimulating Hormone (FSH)
Week 25
|
46.99 Percent Change
Standard Deviation 46.389
|
|
Percent Change From Baseline in Follicle-Stimulating Hormone (FSH)
Week 49
|
62.18 Percent Change
Standard Deviation 78.371
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Luteinizing Hormone (LH)
Week 25
|
184.66 Percent Change
Standard Deviation 120.683
|
|
Percent Change From Baseline in Luteinizing Hormone (LH)
Week 49
|
215.18 Percent Change
Standard Deviation 163.732
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Prolactin
Week 25
|
16.79 Percent Change
Standard Deviation 45.497
|
|
Percent Change From Baseline in Prolactin
Week 49
|
9.64 Percent Change
Standard Deviation 30.003
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
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|---|---|
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Percent Change From Baseline in Total Testosterone
Week 25
|
114.29 Percent Change
Standard Deviation 73.692
|
|
Percent Change From Baseline in Total Testosterone
Week 49
|
101.73 Percent Change
Standard Deviation 76.070
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25 and 49Population: Safety Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
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Percent Change From Baseline in Free Testosterone
Week 49
|
43.74 Percent Change
Standard Deviation 55.721
|
|
Percent Change From Baseline in Free Testosterone
Week 25
|
46.39 Percent Change
Standard Deviation 59.551
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25Population: Pharmacokinetic Analysis Set (PKAS) (participants who had taken at least 1 dose of study drug and who had at least 1 pharmacokinetic concentration value) with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
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Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
Week 2
|
7.225 μg/mL
Standard Deviation 1.8050
|
|
Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
Week 3
|
10.559 μg/mL
Standard Deviation 2.1967
|
|
Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
Week 4
|
11.838 μg/mL
Standard Deviation 2.4605
|
|
Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
Week 5
|
12.161 μg/mL
Standard Deviation 2.8496
|
|
Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
Week 9
|
11.606 μg/mL
Standard Deviation 3.0084
|
|
Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
Week 13
|
11.868 μg/mL
Standard Deviation 2.9760
|
|
Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
Week 21
|
11.224 μg/mL
Standard Deviation 2.8899
|
|
Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
Week 25
|
11.668 μg/mL
Standard Deviation 2.7624
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25Population: Pharmacokinetic Analysis Set with available data at each time point
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
Week 9
|
12.128 μg/mL
Standard Deviation 3.1262
|
|
Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
Week 13
|
12.780 μg/mL
Standard Deviation 3.2564
|
|
Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
Week 21
|
11.717 μg/mL
Standard Deviation 2.9502
|
|
Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
Week 25
|
12.146 μg/mL
Standard Deviation 2.5845
|
|
Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
Week 2
|
2.527 μg/mL
Standard Deviation 1.0440
|
|
Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
Week 3
|
5.344 μg/mL
Standard Deviation 1.7079
|
|
Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
Week 4
|
8.182 μg/mL
Standard Deviation 2.4366
|
|
Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
Week 5
|
9.962 μg/mL
Standard Deviation 2.7584
|
SECONDARY outcome
Timeframe: Baseline and Weeks 49, 97 and 169Population: Safety Analysis Set
A PSA response was defined as a decline from baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 49, week 97 or week 169 for any reason were treated as non-responders.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Percentage of Participants With a PSA Response at Weeks 49, 97 and 169
Week 97
|
67.2 Percentage of Participants
Interval 54.6 to 78.15
|
|
Percentage of Participants With a PSA Response at Weeks 49, 97 and 169
Week 169
|
56.7 Percentage of Participants
Interval 44.04 to 68.78
|
|
Percentage of Participants With a PSA Response at Weeks 49, 97 and 169
Week 49
|
80.6 Percentage of Participants
Interval 69.11 to 89.24
|
SECONDARY outcome
Timeframe: Baseline and Weeks 25, 49, 97 and 169Population: Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point
Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, week 97 or week 169 were considered non-responders.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level
Week 49
|
98.1 Percentage of Participants
|
|
Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level
Week 25
|
91.0 Percentage of Participants
|
|
Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level
Week 97
|
100.0 Percentage of Participants
|
|
Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level
Week 169
|
88.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 25, 49, 97 and 169Population: Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point
Participants with unknown or missing PSA results at week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25. Participants with unknown or missing PSA results at week 49, 97 and 169 were considered non-responders.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Percentage of Participants With PSA ≤ 4 ng/ml
Week 25
|
92.5 Percentage of Participants
|
|
Percentage of Participants With PSA ≤ 4 ng/ml
Week 49
|
94.4 Percentage of Participants
|
|
Percentage of Participants With PSA ≤ 4 ng/ml
Week 97
|
100.0 Percentage of Participants
|
|
Percentage of Participants With PSA ≤ 4 ng/ml
Week 169
|
95.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 25, 49, 97 and 169Population: Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point
Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, 97 or 169 were considered non-responders.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Percentage of Participants With PSA ≤ 0.1 ng/ml
Week 25
|
44.8 Percentage of Participants
|
|
Percentage of Participants With PSA ≤ 0.1 ng/ml
Week 49
|
63.0 Percentage of Participants
|
|
Percentage of Participants With PSA ≤ 0.1 ng/ml
Week 97
|
73.3 Percentage of Participants
|
|
Percentage of Participants With PSA ≤ 0.1 ng/ml
Week 169
|
61.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 25 and from Baseline up to the EOS date of 27 Apr 2017; median duration of treatment of 1666.0 days (range of 52-2052)Population: Safety Analysis Set with available data at each time point
The maximum decline from Baseline in PSA was calculated as the largest reduction from Baseline in PSA level that occurred at any point after treatment start up to week 25 and up to and including the assessment made at the safety follow-up visit, divided by the PSA Baseline value and multiplied by 100, i.e., the maximum percent change from baseline.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Maximum Decline From Baseline in PSA
Maximum Decline by Week 25
|
-98.32 Percent Change
Standard Deviation 2.880
|
|
Maximum Decline From Baseline in PSA
Maximum Decline by EOS
|
-99.10 Percent Change
Standard Deviation 2.659
|
SECONDARY outcome
Timeframe: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)Population: Safety Analysis Set
Time to PSA response (PSA decline ≥ 80% from Baseline) is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 80% or greater was recorded. Time to response was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Time to PSA Response
|
29 Days
Interval 28.0 to 31.0
|
SECONDARY outcome
Timeframe: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)Population: Safety Analysis Set
Time to PSA decline ≥ 90% is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 90% or greater was recorded. Time to PSA decline ≥ 90% was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Time to PSA Decline ≥ 90%
|
55 Days
Interval 29.0 to 57.0
|
SECONDARY outcome
Timeframe: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)Population: Safety Analysis Set
Time to PSA ≤ 4 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 4 ng/ml or below was recorded. Time to PSA ≤ 4 ng/ml was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Time to PSA ≤ 4 ng/ml
|
29 Days
Interval 9.0 to 57.0
|
SECONDARY outcome
Timeframe: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)Population: Safety Analysis Set
Time to PSA ≤ 0.1 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 0.1 ng/ml or below was recorded. Time to PSA ≤ 0.1 ng/ml was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Time to PSA ≤ 0.1 ng/ml
|
168 Days
Interval 58.0 to 581.0
|
SECONDARY outcome
Timeframe: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)Population: Safety Analysis Set
Time to PSA progression is defined as the time interval from the first study drug dose to the first date of PSA progression. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir unless the PSA next measurement(s), if available, does not confirm the PSA progression.
Outcome measures
| Measure |
Enzalutamide
n=67 Participants
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Time to PSA Progression
|
NA Days
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: From Baseline to Week 25Population: Safety Analysis Set with a positive PSA versus time slope
PSA doubling time was to be calculated from the slope estimated from a linear regression of the natural log of PSA fitted on time, if the slope was positive. Since the slope was negative for all participants, PSA doubling time could not be calculated.
Outcome measures
Outcome data not reported
Adverse Events
Enzalutamide
Serious events: 24 serious events
Other events: 66 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Enzalutamide
n=67 participants at risk
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Angina pectoris
|
3.0%
2/67 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Arrhythmia
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Atrial fibrillation
|
6.0%
4/67 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Bradycardia
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Sick sinus syndrome
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
General disorders
Chronic fatigue syndrome
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
General disorders
Device dislocation
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
General disorders
General physical health deterioration
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Infections and infestations
Pneumonia
|
3.0%
2/67 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Infections and infestations
Sepsis
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Infections and infestations
Urosepsis
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Injury, poisoning and procedural complications
Concussion
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.5%
1/67 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bladder
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Depressed level of consciousness
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Dizziness
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Seizure anoxic
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Syncope
|
3.0%
2/67 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Renal and urinary disorders
Hydronephrosis
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Renal and urinary disorders
Urinary retention
|
3.0%
2/67 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Reproductive system and breast disorders
Prostatic calcification
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/67 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
Other adverse events
| Measure |
Enzalutamide
n=67 participants at risk
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.0%
4/67 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Gastrointestinal disorders
Constipation
|
13.4%
9/67 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Gastrointestinal disorders
Diarrhoea
|
16.4%
11/67 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Gastrointestinal disorders
Dry mouth
|
7.5%
5/67 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Gastrointestinal disorders
Nausea
|
16.4%
11/67 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
General disorders
Fatigue
|
41.8%
28/67 • Number of events 40 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
General disorders
Oedema peripheral
|
11.9%
8/67 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Infections and infestations
Cystitis
|
6.0%
4/67 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
6/67 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Infections and infestations
Pneumonia
|
7.5%
5/67 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
4/67 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.0%
4/67 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.9%
10/67 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.0%
4/67 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
4/67 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.4%
7/67 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.9%
8/67 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Dizziness
|
7.5%
5/67 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Headache
|
6.0%
4/67 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Nervous system disorders
Memory impairment
|
9.0%
6/67 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Psychiatric disorders
Depression
|
7.5%
5/67 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Reproductive system and breast disorders
Breast pain
|
9.0%
6/67 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Reproductive system and breast disorders
Gynaecomastia
|
53.7%
36/67 • Number of events 43 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Reproductive system and breast disorders
Nipple pain
|
19.4%
13/67 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
5/67 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.0%
4/67 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.0%
6/67 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
7/67 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
4/67 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Vascular disorders
Hot flush
|
22.4%
15/67 • Number of events 18 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
|
Vascular disorders
Hypertension
|
25.4%
17/67 • Number of events 18 • From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data.Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER