Trial Outcomes & Findings for Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer (NCT NCT01565928)

NCT ID: NCT01565928

Last Updated: 2019-04-22

Results Overview

Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 23 participants
• Primary outcome timeframe: Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days)
• Results posted on: 2019-04-22

Participant Flow

Participant milestones

Measure	Docetaxel 75 mg/m^2+ Enzalutamide 160 mg Docetaxel 75 milligrams per square meter (mg/m\^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70).
Overall Study STARTED	22
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	Docetaxel 75 mg/m^2+ Enzalutamide 160 mg Docetaxel 75 milligrams per square meter (mg/m\^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70).
Overall Study Adverse Event	3
Overall Study Other	3
Overall Study Progressive Disease	13
Overall Study Withdrawal by Subject	1
Overall Study Death	2

Baseline Characteristics

Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

Baseline characteristics by cohort

Measure	Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 Participants Docetaxel 75 milligrams per square meter (mg/m\^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70).
Age, Continuous	68.0 years STANDARD_DEVIATION 10.66 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days)

Population: Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).

Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator.

Outcome measures

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 Participants Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2 Docetaxel Dose Reductions	4.5 percentage of participants	—
Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2 Enzalutamide Dose Reductions	0.0 percentage of participants	—

PRIMARY outcome

Timeframe: Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months)

Population: Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).

AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Percentage of participants that discontinued study drug due to adverse events were reported in this outcome measure.

Outcome measures

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 Participants Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)	9.1 percentage of participants	—

SECONDARY outcome

Timeframe: T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5

Population: Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).

Criteria:1)systolic blood pressure (SBP):a) absolute result(AR)>=180millimeters of mercury(mmHg) and increase from baseline(BL)greater than(>)40mmHg,b)less than(<)90mmHg and decrease from BL>30mmHg,c)most extreme post-BL result>=140mmHg,d)most extreme post-BL result>=180mmHg,e)most extreme result(MER)>=180mmHg and >=20mmHg change from BL,f)MER>=140mmHg and >=20mmHg change from BL;2)diastolic blood pressure(DBP):a)AR>105mmHg and increase from BL,b)AR<50mmHg and decrease from BL>20mmHg;c)most extreme post-BL result>=90mmHg,d)MER>=90mmHg and >=15mmHg change from BL,e)most extreme post-BL result>=105mmHg,f)MER>=105mmHg and>=15mmHg change from BL;3)heart rate:a)AR>120 beats per minute(bpm) and increase from BL>30bpm,b) AR<50 bpm and decrease from BL>20bpm.Only those categories in which at least 1 participant had clinically significant vital sign abnormality, were reported in this outcome measure.T1 = Timeframe for "Combination Therapy" and T2 = Time frame for "Post-Docetaxel Enzalutamide".

Outcome measures

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 Participants Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg n=21 Participants Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Number of Participants With Clinically Significant Abnormalities in Vital Signs SBP: AR- < 90 mmHg, decrease from BL > 30 mmHg	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs SBP: Most extreme post- BL result >= 140 mmHg	10 Participants	7 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs SBP: Most extreme post- BL result >= 180 mmHg	0 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs SBP: MER >= 180 mmHg, >= 20 mmHg change from BL	0 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs DBP: Most extreme post-BL result >= 105 mmHg	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs DBP: MER >= 105 mmHg,>= 15 mmHg change from BL	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs Heart Rate: AR >120 bpm, increase from BL >30 bpm	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs Heart Rate: AR <50 bpm, decrease from BL >30 bpm	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs SBP: AR- > 180 mmHg, increase from BL > 40 mmHg	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs SBP: MER >= 140 mmHg, >= 20 mmHg change from BL	5 Participants	5 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs DBP: Most extreme post-BL result >= 90 mmHg	3 Participants	6 Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs DBP: MER >= 90 mmHg,>= 15 mmHg change from BL	1 Participants	4 Participants

SECONDARY outcome

Timeframe: T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5

Population: Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).

Clinically significant changes from baseline in ECG findings was based up on investigator's discretion. T1 = Timeframe for "Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg" and T2 = Time frame for "Post-Docetaxel Enzalutamide 160 mg".

Outcome measures

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 Participants Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg n=21 Participants Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECG)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2

Population: Pharmacokinetic (PK) population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m\^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category.

Outcome measures

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 Participants Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment Docetaxel Without Enzalutamide	1722.1 nanograms per milliliter Geometric Coefficient of Variation 27.14	—
Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment Docetaxel With Enzalutamide	1662.9 nanograms per milliliter Geometric Coefficient of Variation 23.00	—

SECONDARY outcome

Timeframe: Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2

Population: PK population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m\^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category.

AUClast was observed using a linear mixed-effects model.

Outcome measures

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 Participants Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment Docetaxel Without Enzalutamide	1866.6 nanograms*hour per milliliter Geometric Coefficient of Variation 29.05	—
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment Docetaxel With Enzalutamide	1674.4 nanograms*hour per milliliter Geometric Coefficient of Variation 19.32	—

SECONDARY outcome

Timeframe: Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2

Population: PK population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m\^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category.

AUCinf was observed using a linear mixed-effects model.

Outcome measures

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 Participants Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment Docetaxel Without Enzalutamide	2020.1 nanograms*hour per milliliter Geometric Coefficient of Variation 27.98	—
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment Docetaxel With Enzalutamide	1769.1 nanograms*hour per milliliter Geometric Coefficient of Variation 18.91	—

Adverse Events

Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg

Serious events: 8 serious events

Other events: 21 other events

Deaths: 0 deaths

Post-Docetaxel Enzalutamide 160 mg

Serious events: 7 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 participants at risk Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg n=21 participants at risk Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Cardiac disorders ACUTE CORONARY SYNDROME	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	14.3% 3/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Cardiac disorders ATRIAL FLUTTER	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders ASTHENIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders DEATH	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders IMPAIRED HEALING	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders PYREXIA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations CELLULITIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations PNEUMONIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations SEPSIS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations SEPTIC SHOCK	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations WHITE BLOOD CELL COUNT DECREASED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders FLANK PAIN	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders HAEMATURIA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders HYDRONEPHROSIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders OBSTRUCTIVE UROPATHY	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders RENAL FAILURE ACUTE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Vascular disorders ARTERIOSCLEROSIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Hepatobiliary disorders Hepatic Failure	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Injury, poisoning and procedural complications Fall	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).

Other adverse events

Measure	Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg n=22 participants at risk Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.	Post-Docetaxel Enzalutamide 160 mg n=21 participants at risk Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).
Blood and lymphatic system disorders ANAEMIA	18.2% 4/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	14.3% 3/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Blood and lymphatic system disorders NEUTROPENIA	86.4% 19/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Eye disorders CATARACT	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Eye disorders LACRIMATION INCREASED	22.7% 5/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Eye disorders VISION BLURRED	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders ABDOMINAL PAIN	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	14.3% 3/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders CONSTIPATION	31.8% 7/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	42.9% 9/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders DIARRHOEA	27.3% 6/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders DYSPEPSIA	18.2% 4/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders NAUSEA	40.9% 9/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders STOMATITIS	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders ASTHENIA	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders CHEST PAIN	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders FATIGUE	72.7% 16/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	23.8% 5/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders INFLUENZA LIKE ILLNESS	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders OEDEMA	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders OEDEMA PERIPHERAL	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders PAIN	18.2% 4/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders PYREXIA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations CELLULITIS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations OSTEOMYELITIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations RHINITIS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations URINARY TRACT INFECTION	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD CREATININE INCREASED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD PHOSPHORUS DECREASED	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations WHITE BLOOD CELL COUNT DECREASED	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders DECREASED APPETITE	22.7% 5/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	28.6% 6/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders DEHYDRATION	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders HYPOCALCAEMIA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders ARTHRALGIA	27.3% 6/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	19.0% 4/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders BACK PAIN	36.4% 8/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	23.8% 5/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders BONE PAIN	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders FLANK PAIN	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders GROIN PAIN	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISCOMFORT	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	23.8% 5/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders NECK PAIN	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	14.3% 3/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders DIZZINESS	18.2% 4/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders DYSGEUSIA	27.3% 6/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders HEADACHE	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders NEUROPATHY PERIPHERAL	45.5% 10/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	31.8% 7/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	19.0% 4/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Psychiatric disorders DEPRESSION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Psychiatric disorders INSOMNIA	18.2% 4/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders HAEMORRHAGE URINARY TRACT	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders INCONTINENCE	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders POLLAKIURIA	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	14.3% 3/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders URETHRAL PAIN	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders COUGH	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	27.3% 6/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	19.0% 4/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	18.2% 4/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders ALOPECIA	27.3% 6/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders DRY SKIN	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders NAIL DISORDER	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders RASH	13.6% 3/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	14.3% 3/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Vascular disorders HOT FLUSH	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	9.5% 2/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Vascular disorders HYPERTENSION	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Vascular disorders HYPOTENSION	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Vascular disorders INTERMITTENT CLAUDICATION	9.1% 2/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Cardiac disorders ANGINA PECTORIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Ear and labyrinth disorders DEAFNESS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Ear and labyrinth disorders TINNITUS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Eye disorders BLEPHAROSPASM	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Eye disorders DRY EYE	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Eye disorders EYE IRRITATION	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Eye disorders EYE PRURITUS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders ABDOMINAL PAIN LOWER	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders DYSPHAGIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders FAECES DISCOLOURED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders FLATULENCE	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders HAEMORRHOIDS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders OESOPHAGEAL PAIN	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders ORAL DISORDER	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Gastrointestinal disorders PARAESTHESIA ORAL	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders CATHETER SITE ERYTHEMA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders CHILLS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders GAIT DISTURBANCE	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders GENERALISED OEDEMA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders IMPAIRED HEALING	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
General disorders MEDICAL DEVICE PAIN	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Hepatobiliary disorders CHOLELITHIASIS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations DEVICE RELATED INFECTION	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations FURUNCLE	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations HEPATOSPLENIC CANDIDIASIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations INFUSION SITE INFECTION	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations LOCALISED INFECTION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations MUCOSAL INFECTION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations ORAL INFECTION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Infections and infestations SKIN INFECTION	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Injury, poisoning and procedural complications FALL	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Injury, poisoning and procedural complications LACERATION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Injury, poisoning and procedural complications SPINAL FRACTURE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD CALCIUM DECREASED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD CHOLESTEROL INCREASED	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD GLUCOSE DECREASED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD MAGNESIUM DECREASED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD POTASSIUM INCREASED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations BLOOD URIC ACID INCREASED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations ELECTROCARDIOGRAM QT PROLONGED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Investigations WEIGHT DECREASED	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders ACIDOSIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders FAILURE TO THRIVE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Metabolism and nutrition disorders HYPERCALCAEMIA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders OSTEONECROSIS OF JAW	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Musculoskeletal and connective tissue disorders PAIN IN JAW	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders AMNESIA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders APHASIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders BALANCE DISORDER	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders COGNITIVE DISORDER	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders HYPOKINESIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Nervous system disorders PARAESTHESIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Psychiatric disorders AGITATION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders BLADDER SPASM	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders HAEMATURIA	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Reproductive system and breast disorders NIPPLE DISORDER	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Reproductive system and breast disorders SCROTAL OEDEMA	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders NAIL DISCOLOURATION	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders ONYCHOMADESIS	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Vascular disorders ARTERIOSCLEROSIS	0.00% 0/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	4.8% 1/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).
Vascular disorders FLUSHING	4.5% 1/22 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).	0.00% 0/21 • Baseline up to a maximum of approximately Month 12 for Combination Therapy; From Month 10.6 up to a maximum of approximately Month 71.5 for Post-Docetaxel Enzalutamide An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER