| Primary | Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25 | 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. | The analysis population was safety analysis set (SAF), which consisted of participants who received at least one dose of study drug. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00092.5(83.44 to 97.53)
|
|
| |
| Secondary | Number of Participants With Adverse Events | 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.
| | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Percent Change From Baseline in PSA | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG) | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Androstenedione | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Dehydroepiandrosterone (DHEA) | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Dihydrotestosterone (DHT) | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Estradiol | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Follicle-Stimulating Hormone (FSH) | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Luteinizing Hormone (LH) | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Prolactin | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Total Testosterone | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Percent Change From Baseline in Free Testosterone | | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Weeks 25 and 49 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Secondary | Plasma Concentration of Enzalutamide at Pre-dose (Ctrough) | | 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 | Posted | | Mean | Standard Deviation | μg/mL | | Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough) | | Pharmacokinetic Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | μg/mL | | Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Percentage of Participants With a PSA Response at Weeks 49, 97 and 169 | 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. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline and Weeks 49, 97 and 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level | 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. | Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point | Posted | | Number | | Percentage of Participants | | Baseline and Weeks 25, 49, 97 and 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Percentage of Participants With PSA ≤ 4 ng/ml | 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. | Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point | Posted | | Number | | Percentage of Participants | | Weeks 25, 49, 97 and 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Percentage of Participants With PSA ≤ 0.1 ng/ml | 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. | Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point | Posted | | Number | | Percentage of Participants | | Weeks 25, 49, 97 and 169 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Maximum Decline From Baseline in PSA | 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. | Safety Analysis Set with available data at each time point | Posted | | Mean | Standard Deviation | Percent Change | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Time to PSA Response | 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. | | Posted | | Median | Inter-Quartile Range | Days | | From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Time to PSA Decline ≥ 90% | 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. | | Posted | | Median | Inter-Quartile Range | Days | | From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Time to PSA ≤ 4 ng/ml | 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. | | Posted | | Median | Inter-Quartile Range | Days | | From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Time to PSA ≤ 0.1 ng/ml | 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. | | Posted | | Median | Inter-Quartile Range | Days | | From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Time to PSA Progression | 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. | | Posted | | Median | Inter-Quartile Range | Days | | From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | PSA Doubling Time | 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. | Safety Analysis Set with a positive PSA versus time slope | Posted | | | | | | From Baseline to Week 25 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |