Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00887198

Recruitment Status : Completed

First Posted : April 23, 2009

Results First Posted : April 9, 2015

Last Update Posted : June 25, 2018

Sponsor:

Information provided by (Responsible Party):

Janssen Research & Development, LLC

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Prostate Cancer
Interventions	Drug: Abiraterone acetate Drug: Placebo Drug: Prednisone
Enrollment	1088

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo	Placebo to AA
Arm/Group Description	Participants received 1000 milligra...	Participants received placebo match...	Participants who were originally as...
Arm/Group Description	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet.
Period Title: Randomized Period
Started	546	542	0
Treated	542	540	0
Completed	0	0	0
Not Completed	546	542	0
Reason Not Completed
Ongoing	42	0	0
Adverse Event	50	33	0
Lost to Follow-up	1	0	0
Cross-over to AA (under amendment 3)	0	51	0
Withdrawal by Subject	41	56	0
Progressive disease	366	370	0
Other	42	30	0
Randomized, Not treated	4	2	0
Period Title: Cross Over (Placebo to AA)
Started	0	0	93 ^[1]
Completed	0	0	0
Not Completed	0	0	93
Reason Not Completed
Started other prostate cancer treatment	0	0	8
Ongoing	0	0	35
Adverse Event	0	0	9
Withdrawal by Subject	0	0	2
Progressive disease	0	0	20
Other	0	0	19
[1] 93= 51 participants(crossed over under amendment 3)+42 participants (crossed over under amendment 4)

Baseline Characteristics

Arm/Group Title		Abiraterone Acetate + Prednisone (AAP)	Placebo	Total
Arm/Group Description		Participants received 1000 milligra...	Participants received placebo match...	Total of all reporting groups
Arm/Group Description		Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Total of all reporting groups
Overall Number of Baseline Participants		546	542	1088
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	546 participants	542 participants	1088 participants
		70.5 (8.8)	70.1 (8.72)	70.3 (8.76)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	546 participants	542 participants	1088 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	546 100.0%	542 100.0%	1088 100.0%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	546 participants	542 participants	1088 participants
Australia		60 11.0%	72 13.3%	132 12.1%
Belgium		25 4.6%	17 3.1%	42 3.9%
Canada		63 11.5%	37 6.8%	100 9.2%
France		24 4.4%	29 5.4%	53 4.9%
Germany		46 8.4%	32 5.9%	78 7.2%
Greece		7 1.3%	7 1.3%	14 1.3%
Italy		1 0.2%	6 1.1%	7 0.6%
Netherlands		15 2.7%	15 2.8%	30 2.8%
Spain		25 4.6%	20 3.7%	45 4.1%
Sweden		4 0.7%	13 2.4%	17 1.6%
United Kingdom		42 7.7%	56 10.3%	98 9.0%
United States		234 42.9%	238 43.9%	472 43.4%

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	Overall survival is defined as the time from randomization to date of ...
Description	Overall survival is defined as the time from randomization to date of death from any cause.
Time Frame	From randomization (Day 1) up to end of study (Month 60)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	546	542
Median (95% Confidence Interval) Unit of Measure: Months
	34.66 (32.72 to 36.80)	30.29 (28.65 to 33.28)

2.Primary Outcome


Title	Radiographic Progression-free Survival (rPFS)
Description	The rPFS was defined as the time from randomization to the occurrence ...
Description	The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
Time Frame	From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Outcome Measure Data

Analysis Population Description

ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	546	542
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (11.66 to NA)	8.28 (8.12 to 8.54)

[1]

Data was not estimable due to insufficient number of participants who had the event.

3.Secondary Outcome


Title	Time to Opiate Use for Prostate Cancer Pain
Description	The time interval from the date of randomization to the date of opiate...
Description	The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.
Time Frame	From randomization (Day 1) up to first opiate use or end of study (Month 60)

Outcome Measure Data

Analysis Population Description

ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	546	542
Median (95% Confidence Interval) Unit of Measure: Months
	33.38 (30.23 to 39.75)	23.39 (20.27 to 27.53)

4.Secondary Outcome


Title	Time to Initiation of Cytotoxic Chemotherapy
Description	The time interval from the date of randomization to the date of initia...
Description	The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.
Time Frame	From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)

Outcome Measure Data

Analysis Population Description

ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	546	542
Median (95% Confidence Interval) Unit of Measure: Months
	25.17 ^[1] (23.26 to NA)	16.82 (14.55 to 19.38)

[1]

Upper limit was not estimable due to insufficient number of participants who had the event.

5.Secondary Outcome


Title	Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
Description	The time interval from the date of randomization to the first date at ...
Description	The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
Time Frame	From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Outcome Measure Data

Analysis Population Description

ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	546	542
Median (95% Confidence Interval) Unit of Measure: Months
	12.29 (11.33 to 14.29)	10.87 (9.49 to 11.76)

6.Secondary Outcome


Title	Time to Prostate-specific Antigen (PSA) Progression
Description	The time interval from the date of randomization to the date of PSA pr...
Description	The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.
Time Frame	From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)

Outcome Measure Data

Analysis Population Description

ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	546	542
Median (95% Confidence Interval) Unit of Measure: Months
	11.07 (8.51 to 11.24)	5.55 (5.39 to 5.59)

7.Secondary Outcome


Title	Number of Participants With Treatment Emergent Adverse Events
Description	An adverse event (AE) was any untoward medical occurrence in a partici...
Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame	From first dose of study drug up to 30 days after the last dose of study drug

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants in the randomized population who received any study drug.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo	Placebo to Abiraterone Acetate
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...	Participants received initially pla...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
Overall Number of Participants Analyzed	542	540	93
Measure Type: Number Unit of Measure: Participants
With Treatment-Emergent Adverse Events	541	524	93
With Treatment-Emergent Serious Adverse Events	208	148	39

8.Secondary Outcome


Title	Mean Plasma Concentrations of Abiraterone
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to Cycle 5, Day 1

Outcome Measure Data

Analysis Population Description

Data was not reported as non-compartmental analysis was not performed due to sparse sampling.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

9.Secondary Outcome


Title	Maximum Plasma Concentrations of Abiraterone
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to Cycle 5, Day 1

Outcome Measure Data

Analysis Population Description

Data was not reported as non-compartmental analysis was not performed due to sparse sampling.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

10.Secondary Outcome


Title	Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])
Description	The AUC (0-infinity) is the area under the plasma concentration-time c...
Description	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time Frame	Up to Cycle 5, Day 1

Outcome Measure Data

Analysis Population Description

Data was not reported as non-compartmental analysis was not performed due to sparse sampling.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

11.Secondary Outcome


Title	Elimination Half-Life (t1/2)
Description	The elimination half-life (t1/2) is the time measured for the plasma c...
Description	The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Time Frame	Up to Cycle 5, Day 1

Outcome Measure Data

Analysis Population Description

Data was not reported as non-compartmental analysis was not performed due to sparse sampling.


Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo
Arm/Group Description:	Participants received 1000 milligra...	Participants received placebo match...
Arm/Group Description:	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	From first dose of study drug up to 30 days after the last dose of study drug (Approximately 5 years)
Adverse Event Reporting Description	Safety analysis set included all participants in the randomized population who received any study drug.

Arm/Group Title	Abiraterone Acetate + Prednisone (AAP)	Placebo	Placebo to AA
Arm/Group Description	Participants received 1000 milligra...	Participants received placebo match...	Participants who were originally as...
Arm/Group Description	Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet.
All-Cause Mortality
	Abiraterone Acetate + Prednisone (AAP)	Placebo	Placebo to AA
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Abiraterone Acetate + Prednisone (AAP)	Placebo	Placebo to AA
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	215/542 (39.67%)	156/540 (28.89%)	40/93 (43.01%)
Blood and lymphatic system disorders
Anaemia ^* 1	8/542 (1.48%)	6/540 (1.11%)	1/93 (1.08%)
Coagulopathy ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Leukocytosis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Lymphopenia ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Thrombocytopenia ^* 1	1/542 (0.18%)	1/540 (0.19%)	1/93 (1.08%)
Disseminated Intravascular Coagulation ^* 1	1/542 (0.18%)	0/540 (0.00%)	1/93 (1.08%)
Febrile Neutropenia ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Cardiac disorders
Tachyarrhythmia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Acute Coronary Syndrome ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Acute Myocardial Infarction ^* 1	1/542 (0.18%)	0/540 (0.00%)	1/93 (1.08%)
Angina Pectoris ^* 1	6/542 (1.11%)	1/540 (0.19%)	0/93 (0.00%)
Atrial Fibrillation ^* 1	11/542 (2.03%)	8/540 (1.48%)	0/93 (0.00%)
Atrioventricular Block ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Atrioventricular Block Second Degree ^* 1	1/542 (0.18%)	0/540 (0.00%)	1/93 (1.08%)
Bifascicular Block ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Cardiac Arrest ^* 1	1/542 (0.18%)	2/540 (0.37%)	0/93 (0.00%)
Cardiac Disorder ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Cardiac Failure ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Cardiac Failure Congestive ^* 1	3/542 (0.55%)	0/540 (0.00%)	0/93 (0.00%)
Conduction Disorder ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Coronary Artery Disease ^* 1	4/542 (0.74%)	1/540 (0.19%)	0/93 (0.00%)
Ischaemic Cardiomyopathy ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Myocardial Infarction ^* 1	4/542 (0.74%)	5/540 (0.93%)	2/93 (2.15%)
Myocardial Ischaemia ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Supraventricular Tachyarrhythmia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Supraventricular Tachycardia ^* 1	2/542 (0.37%)	0/540 (0.00%)	1/93 (1.08%)
Ear and labyrinth disorders
Hypoacusis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Vertigo ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Endocrine disorders
Adrenal Insufficiency ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Gastrointestinal disorders
Colitis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Constipation ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Diarrhoea ^* 1	2/542 (0.37%)	0/540 (0.00%)	1/93 (1.08%)
Dyspepsia ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Gastritis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Ileus ^* 1	2/542 (0.37%)	1/540 (0.19%)	0/93 (0.00%)
Melaena ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Nausea ^* 1	2/542 (0.37%)	0/540 (0.00%)	1/93 (1.08%)
Pancreatitis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Periodontitis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Peritonitis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Vomiting ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Abdominal Pain ^* 1	3/542 (0.55%)	5/540 (0.93%)	0/93 (0.00%)
Abdominal Pain Lower ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Abdominal Pain Upper ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Diverticular Perforation ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Diverticulum Intestinal ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Diverticulum Intestinal Haemorrhagic ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Enterovesical Fistula ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Food Poisoning ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Gastric Ulcer ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Gastritis Erosive ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Gastrointestinal Haemorrhage ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Gastrointestinal Necrosis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Gastrooesophageal Reflux Disease ^* 1	2/542 (0.37%)	1/540 (0.19%)	0/93 (0.00%)
Intestinal Ischaemia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Intestinal Obstruction ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Oesophageal Mass ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Pancreatic Disorder ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Pancreatitis Necrotising ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Small Intestinal Obstruction ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Upper Gastrointestinal Haemorrhage ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Varices Oesophageal ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
General disorders
Asthenia ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Fatigue ^* 1	2/542 (0.37%)	0/540 (0.00%)	2/93 (2.15%)
Malaise ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Pain ^* 1	0/542 (0.00%)	1/540 (0.19%)	1/93 (1.08%)
Pyrexia ^* 1	3/542 (0.55%)	3/540 (0.56%)	0/93 (0.00%)
Catheter Related Complication ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Chest Pain ^* 1	0/542 (0.00%)	1/540 (0.19%)	1/93 (1.08%)
Death ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Disease Progression ^* 1	8/542 (1.48%)	4/540 (0.74%)	6/93 (6.45%)
Gait Disturbance ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
General Physical Health Deterioration ^* 1	7/542 (1.29%)	2/540 (0.37%)	0/93 (0.00%)
Hypothermia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Mucosal Inflammation ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Multi-Organ Failure ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Non-Cardiac Chest Pain ^* 1	1/542 (0.18%)	4/540 (0.74%)	1/93 (1.08%)
Oedema Peripheral ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Performance Status Decreased ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Systemic Inflammatory Response Syndrome ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Hepatobiliary disorders
Cholecystitis ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Cholelithiasis ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Jaundice ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Bile Duct Obstruction ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Infections and infestations
Bacteraemia ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Bronchitis ^* 1	1/542 (0.18%)	2/540 (0.37%)	0/93 (0.00%)
Bronchopneumonia ^* 1	0/542 (0.00%)	2/540 (0.37%)	0/93 (0.00%)
Cellulitis ^* 1	2/542 (0.37%)	3/540 (0.56%)	2/93 (2.15%)
Cystitis ^* 1	3/542 (0.55%)	0/540 (0.00%)	0/93 (0.00%)
Gastroenteritis ^* 1	6/542 (1.11%)	1/540 (0.19%)	0/93 (0.00%)
Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Influenza ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Osteomyelitis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Pneumonia ^* 1	10/542 (1.85%)	4/540 (0.74%)	1/93 (1.08%)
Pyelonephritis ^* 1	3/542 (0.55%)	2/540 (0.37%)	1/93 (1.08%)
Sepsis ^* 1	7/542 (1.29%)	2/540 (0.37%)	1/93 (1.08%)
Sinusitis ^* 1	2/542 (0.37%)	1/540 (0.19%)	0/93 (0.00%)
Tracheobronchitis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Urosepsis ^* 1	3/542 (0.55%)	2/540 (0.37%)	1/93 (1.08%)
Anal Abscess ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Arthritis Bacterial ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Biliary Sepsis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Bursitis Infective ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Campylobacter Gastroenteritis ^* 1	1/542 (0.18%)	0/540 (0.00%)	1/93 (1.08%)
Enterococcal Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Escherichia Urinary Tract Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Febrile Infection ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Gallbladder Abscess ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Gastroenteritis Salmonella ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Gastroenteritis Viral ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Gastrointestinal Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Gingival Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Herpes Zoster ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Infected Skin Ulcer ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Infective Exacerbation of Chronic Obstructive Airways Disease ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Lower Respiratory Tract Infection ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Lung Infection ^* 1	3/542 (0.55%)	0/540 (0.00%)	0/93 (0.00%)
Necrotising Fasciitis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Parainfluenzae Virus Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Pneumonia Influenzal ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Pneumonia Staphylococcal ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Postoperative Wound Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Pseudomonal Bacteraemia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Respiratory Tract Infection ^* 1	3/542 (0.55%)	0/540 (0.00%)	0/93 (0.00%)
Skin Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Staphylococcal Infection ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Urinary Tract Infection ^* 1	14/542 (2.58%)	4/540 (0.74%)	5/93 (5.38%)
Urinary Tract Infection Bacterial ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Viral Infection ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Wound Infection ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Injury, poisoning and procedural complications
Fall ^* 1	2/542 (0.37%)	2/540 (0.37%)	1/93 (1.08%)
Animal Scratch ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Ankle Fracture ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Bladder Perforation ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Cataract Operation Complication ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Cystitis Radiation ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Device Dislocation ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Femoral Neck Fracture ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Femur Fracture ^* 1	2/542 (0.37%)	1/540 (0.19%)	0/93 (0.00%)
Gastroenteritis Radiation ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Gastrointestinal Anastomotic Leak ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Implantable Defibrillator Malfunction ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Multiple Fractures ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Multiple Injuries ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Narcotic Intoxication ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Procedural Pain ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Pubic Rami Fracture ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Scapula Fracture ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Skeletal Injury ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Skin Laceration ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Skull Fracture ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Soft Tissue Injury ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Spinal Compression Fracture ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Spinal Fracture ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Stress Fracture ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Subdural Haematoma ^* 1	0/542 (0.00%)	2/540 (0.37%)	2/93 (2.15%)
Subdural Haemorrhage ^* 1	0/542 (0.00%)	2/540 (0.37%)	0/93 (0.00%)
Tendon Rupture ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Thoracic Vertebral Fracture ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Tibia Fracture ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Wrist Fracture ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Investigations
Colonoscopy ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Alanine Aminotransferase Increased ^* 1	5/542 (0.92%)	1/540 (0.19%)	0/93 (0.00%)
Aspartate Aminotransferase Increased ^* 1	3/542 (0.55%)	1/540 (0.19%)	0/93 (0.00%)
Blood Creatinine Increased ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Blood Uric Acid Increased ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Electrocardiogram QT Prolonged ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Electrocardiogram St Segment Depression ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Lipase Increased ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Platelet Count Decreased ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Metabolism and nutrition disorders
Anorexia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Dehydration ^* 1	6/542 (1.11%)	1/540 (0.19%)	0/93 (0.00%)
Hyperuricaemia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Hypoalbuminaemia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Hypoglycaemia ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Hypokalaemia ^* 1	2/542 (0.37%)	1/540 (0.19%)	0/93 (0.00%)
Hyponatraemia ^* 1	2/542 (0.37%)	1/540 (0.19%)	1/93 (1.08%)
Failure to Thrive ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Fluid Retention ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^* 1	2/542 (0.37%)	4/540 (0.74%)	0/93 (0.00%)
Arthritis ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Bursitis ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Osteitis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Osteoarthritis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Osteonecrosis ^* 1	2/542 (0.37%)	1/540 (0.19%)	0/93 (0.00%)
Back Pain ^* 1	6/542 (1.11%)	4/540 (0.74%)	1/93 (1.08%)
Bone Pain ^* 1	4/542 (0.74%)	5/540 (0.93%)	1/93 (1.08%)
Flank Pain ^* 1	2/542 (0.37%)	1/540 (0.19%)	0/93 (0.00%)
Groin Pain ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Jaw Cyst ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Joint Swelling ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Lumbar Spinal Stenosis ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Muscular Weakness ^* 1	1/542 (0.18%)	0/540 (0.00%)	1/93 (1.08%)
Musculoskeletal Chest Pain ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Musculoskeletal Pain ^* 1	1/542 (0.18%)	2/540 (0.37%)	0/93 (0.00%)
Pain in Extremity ^* 1	1/542 (0.18%)	1/540 (0.19%)	2/93 (2.15%)
Pathological Fracture ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Rotator Cuff Syndrome ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Spinal Column Stenosis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Type Acute Leukaemia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Basal Cell Carcinoma ^* 1	1/542 (0.18%)	0/540 (0.00%)	1/93 (1.08%)
Bladder Cancer ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Bladder Transitional Cell Carcinoma ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Cancer Pain ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Central Nervous System Lymphoma ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Chronic Lymphocytic Leukaemia ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Colon Adenoma ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Colon Cancer ^* 1	0/542 (0.00%)	2/540 (0.37%)	0/93 (0.00%)
Colorectal Cancer ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Gastric Cancer ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Intestinal Adenocarcinoma ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Lung Adenocarcinoma ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Lung Neoplasm ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Lung Neoplasm Malignant ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Malignant Melanoma ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Malignant Neoplasm of Ampulla of Vater ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Metastases to Meninges ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Metastatic Pain ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Pancreatic Carcinoma ^* 1	2/542 (0.37%)	0/540 (0.00%)	1/93 (1.08%)
Squamous Cell Carcinoma ^* 1	1/542 (0.18%)	0/540 (0.00%)	1/93 (1.08%)
Urethral Cancer ^* 1	0/542 (0.00%)	1/540 (0.19%)	1/93 (1.08%)
Nervous system disorders
Convulsion ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Dizziness ^* 1	2/542 (0.37%)	1/540 (0.19%)	0/93 (0.00%)
Epilepsy ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Monoparesis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Paraesthesia ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Paraparesis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Paraplegia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Presyncope ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Quadriparesis ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Sciatica ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Syncope ^* 1	6/542 (1.11%)	1/540 (0.19%)	0/93 (0.00%)
VIth nerve paralysis ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Amyotrophic Lateral Sclerosis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Carotid Artery Stenosis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Cerebral Haemorrhage ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Cerebral Infarction ^* 1	0/542 (0.00%)	2/540 (0.37%)	0/93 (0.00%)
Cerebral Ischaemia ^* 1	3/542 (0.55%)	0/540 (0.00%)	0/93 (0.00%)
Cerebrovascular Accident ^* 1	6/542 (1.11%)	2/540 (0.37%)	0/93 (0.00%)
Embolic Stroke ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Loss of Consciousness ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Memory Impairment ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Migraine with Aura ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Nerve Root Compression ^* 1	2/542 (0.37%)	0/540 (0.00%)	1/93 (1.08%)
Neurological Symptom ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Spinal Cord Compression ^* 1	7/542 (1.29%)	4/540 (0.74%)	0/93 (0.00%)
Syncope Vasovagal ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Transient Ischaemic Attack ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Psychiatric disorders
Agitation ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Delirium ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Completed Suicide ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Confusional State ^* 1	1/542 (0.18%)	2/540 (0.37%)	0/93 (0.00%)
Renal and urinary disorders
Dysuria ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Haematuria ^* 1	11/542 (2.03%)	5/540 (0.93%)	3/93 (3.23%)
Hydronephrosis ^* 1	2/542 (0.37%)	4/540 (0.74%)	0/93 (0.00%)
Nephrolithiasis ^* 1	3/542 (0.55%)	0/540 (0.00%)	0/93 (0.00%)
Pollakiuria ^* 1	3/542 (0.55%)	2/540 (0.37%)	0/93 (0.00%)
Bladder Mass ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Bladder Obstruction ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Bladder Spasm ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Bladder Tamponade ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Calculus Bladder ^* 1	0/542 (0.00%)	0/540 (0.00%)	2/93 (2.15%)
Calculus Ureteric ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Haemorrhage Urinary Tract ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Obstructive Uropathy ^* 1	0/542 (0.00%)	2/540 (0.37%)	0/93 (0.00%)
Renal Colic ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Renal Failure ^* 1	1/542 (0.18%)	3/540 (0.56%)	0/93 (0.00%)
Renal Failure Acute ^* 1	3/542 (0.55%)	2/540 (0.37%)	1/93 (1.08%)
Renal Impairment ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Ureteric Obstruction ^* 1	2/542 (0.37%)	2/540 (0.37%)	0/93 (0.00%)
Ureteric Stenosis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Urethral Obstruction ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Urethral Stenosis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Urinary Incontinence ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Urinary Retention ^* 1	6/542 (1.11%)	3/540 (0.56%)	1/93 (1.08%)
Urinary Tract Obstruction ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Reproductive system and breast disorders
Prostatomegaly ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Erectile Dysfunction ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Prostatic Haemorrhage ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Scrotal Pain ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^* 1	2/542 (0.37%)	5/540 (0.93%)	0/93 (0.00%)
Hypoxia ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Pneumothorax ^* 1	3/542 (0.55%)	1/540 (0.19%)	0/93 (0.00%)
Acute Pulmonary Oedema ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Chronic Obstructive Pulmonary Disease ^* 1	0/542 (0.00%)	2/540 (0.37%)	0/93 (0.00%)
Lung Disorder ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Pleural Effusion ^* 1	1/542 (0.18%)	3/540 (0.56%)	0/93 (0.00%)
Pneumonia Aspiration ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Pulmonary Embolism ^* 1	10/542 (1.85%)	12/540 (2.22%)	1/93 (1.08%)
Respiratory Failure ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Tonsillar Cyst ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Skin and subcutaneous tissue disorders
Lentigo ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Actinic Keratosis ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Skin Lesion ^* 1	0/542 (0.00%)	0/540 (0.00%)	1/93 (1.08%)
Surgical and medical procedures
Chemotherapy ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Pancreatectomy ^* 1	2/542 (0.37%)	0/540 (0.00%)	0/93 (0.00%)
Aortic Valve Replacement ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Knee Arthroplasty ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Transurethral Prostatectomy ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Vascular disorders
Hypertension ^* 1	1/542 (0.18%)	3/540 (0.56%)	0/93 (0.00%)
Hypotension ^* 1	1/542 (0.18%)	1/540 (0.19%)	0/93 (0.00%)
Thrombophlebitis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Thrombosis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Arterial Thrombosis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Deep Vein Thrombosis ^* 1	4/542 (0.74%)	2/540 (0.37%)	0/93 (0.00%)
Embolism Venous ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Hypertensive Crisis ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Orthostatic Hypotension ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Peripheral Embolism ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
Peripheral Vascular Disorder ^* 1	1/542 (0.18%)	0/540 (0.00%)	0/93 (0.00%)
Venous Thrombosis ^* 1	0/542 (0.00%)	1/540 (0.19%)	0/93 (0.00%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA Version 11.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Abiraterone Acetate + Prednisone (AAP)	Placebo	Placebo to AA
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	530/542 (97.79%)	505/540 (93.52%)	86/93 (92.47%)
Blood and lymphatic system disorders
Anaemia ^* 1	59/542 (10.89%)	53/540 (9.81%)	12/93 (12.90%)
Gastrointestinal disorders
Constipation ^* 1	144/542 (26.57%)	112/540 (20.74%)	15/93 (16.13%)
Diarrhoea ^* 1	135/542 (24.91%)	98/540 (18.15%)	13/93 (13.98%)
Dyspepsia ^* 1	62/542 (11.44%)	28/540 (5.19%)	1/93 (1.08%)
Nausea ^* 1	144/542 (26.57%)	127/540 (23.52%)	15/93 (16.13%)
Vomiting ^* 1	86/542 (15.87%)	61/540 (11.30%)	12/93 (12.90%)
Abdominal Pain ^* 1	49/542 (9.04%)	44/540 (8.15%)	5/93 (5.38%)
General disorders
Asthenia ^* 1	46/542 (8.49%)	46/540 (8.52%)	1/93 (1.08%)
Fatigue ^* 1	243/542 (44.83%)	200/540 (37.04%)	27/93 (29.03%)
Pyrexia ^* 1	54/542 (9.96%)	33/540 (6.11%)	5/93 (5.38%)
Oedema Peripheral ^* 1	148/542 (27.31%)	119/540 (22.04%)	22/93 (23.66%)
Infections and infestations
Bronchitis ^* 1	34/542 (6.27%)	14/540 (2.59%)	0/93 (0.00%)
Nasopharyngitis ^* 1	65/542 (11.99%)	46/540 (8.52%)	5/93 (5.38%)
Sinusitis ^* 1	29/542 (5.35%)	5/540 (0.93%)	3/93 (3.23%)
Lower Respiratory Tract Infection ^* 1	12/542 (2.21%)	13/540 (2.41%)	5/93 (5.38%)
Upper Respiratory Tract Infection ^* 1	74/542 (13.65%)	43/540 (7.96%)	4/93 (4.30%)
Urinary Tract Infection ^* 1	49/542 (9.04%)	40/540 (7.41%)	11/93 (11.83%)
Injury, poisoning and procedural complications
Contusion ^* 1	81/542 (14.94%)	49/540 (9.07%)	6/93 (6.45%)
Fall ^* 1	47/542 (8.67%)	20/540 (3.70%)	12/93 (12.90%)
Skin Laceration ^* 1	13/542 (2.40%)	15/540 (2.78%)	6/93 (6.45%)
Investigations
Alanine Aminotransferase Increased ^* 1	70/542 (12.92%)	26/540 (4.81%)	3/93 (3.23%)
Aspartate Aminotransferase Increased ^* 1	63/542 (11.62%)	25/540 (4.63%)	4/93 (4.30%)
Weight Decreased ^* 1	42/542 (7.75%)	27/540 (5.00%)	6/93 (6.45%)
Weight Increased ^* 1	29/542 (5.35%)	40/540 (7.41%)	2/93 (2.15%)
Metabolism and nutrition disorders
Anorexia ^* 1	56/542 (10.33%)	40/540 (7.41%)	10/93 (10.75%)
Hyperglycaemia ^* 1	52/542 (9.59%)	41/540 (7.59%)	6/93 (6.45%)
Hypokalaemia ^* 1	99/542 (18.27%)	68/540 (12.59%)	9/93 (9.68%)
Hyponatraemia ^* 1	14/542 (2.58%)	15/540 (2.78%)	5/93 (5.38%)
Decreased Appetite ^* 1	28/542 (5.17%)	30/540 (5.56%)	0/93 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^* 1	172/542 (31.73%)	131/540 (24.26%)	19/93 (20.43%)
Myalgia ^* 1	40/542 (7.38%)	32/540 (5.93%)	3/93 (3.23%)
Back Pain ^* 1	199/542 (36.72%)	180/540 (33.33%)	26/93 (27.96%)
Bone Pain ^* 1	144/542 (26.57%)	112/540 (20.74%)	14/93 (15.05%)
Groin Pain ^* 1	41/542 (7.56%)	22/540 (4.07%)	0/93 (0.00%)
Muscle Spasms ^* 1	78/542 (14.39%)	111/540 (20.56%)	2/93 (2.15%)
Muscular Weakness ^* 1	35/542 (6.46%)	42/540 (7.78%)	5/93 (5.38%)
Musculoskeletal Pain ^* 1	97/542 (17.90%)	77/540 (14.26%)	12/93 (12.90%)
Neck Pain ^* 1	30/542 (5.54%)	17/540 (3.15%)	2/93 (2.15%)
Pain in Extremity ^* 1	107/542 (19.74%)	89/540 (16.48%)	16/93 (17.20%)
Nervous system disorders
Dizziness ^* 1	81/542 (14.94%)	73/540 (13.52%)	7/93 (7.53%)
Headache ^* 1	86/542 (15.87%)	66/540 (12.22%)	9/93 (9.68%)
Neuropathy Peripheral ^* 1	12/542 (2.21%)	6/540 (1.11%)	7/93 (7.53%)
Psychiatric disorders
Anxiety ^* 1	30/542 (5.54%)	23/540 (4.26%)	4/93 (4.30%)
Depression ^* 1	32/542 (5.90%)	19/540 (3.52%)	3/93 (3.23%)
Insomnia ^* 1	82/542 (15.13%)	62/540 (11.48%)	5/93 (5.38%)
Renal and urinary disorders
Haematuria ^* 1	56/542 (10.33%)	32/540 (5.93%)	4/93 (4.30%)
Nocturia ^* 1	38/542 (7.01%)	29/540 (5.37%)	0/93 (0.00%)
Pollakiuria ^* 1	56/542 (10.33%)	55/540 (10.19%)	2/93 (2.15%)
Urinary Incontinence ^* 1	37/542 (6.83%)	25/540 (4.63%)	0/93 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	106/542 (19.56%)	74/540 (13.70%)	11/93 (11.83%)
Dyspnoea ^* 1	71/542 (13.10%)	52/540 (9.63%)	7/93 (7.53%)
Skin and subcutaneous tissue disorders
Rash ^* 1	49/542 (9.04%)	21/540 (3.89%)	1/93 (1.08%)
Vascular disorders
Hypertension ^* 1	129/542 (23.80%)	73/540 (13.52%)	6/93 (6.45%)
Hot Flush ^* 1	124/542 (22.88%)	100/540 (18.52%)	6/93 (6.45%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA Version 11.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

A copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	SENIOR DIRECTOR CLINICAL RESEARCH
Organization:	Janssen R&D US
EMail:	ClinicalTrialDisclosure@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Miller K, Carles J, Gschwend JE, Van Poppel H, Diels J, Brookman-May SD. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-specific Antigen, and Gleason Score. Eur Urol. 2018 Jul;74(1):17-23. doi: 10.1016/j.eururo.2017.08.035. Epub 2017 Sep 20.

de Bono JS, Smith MR, Saad F, Rathkopf DE, Mulders PFA, Small EJ, Shore ND, Fizazi K, De Porre P, Kheoh T, Li J, Todd MB, Ryan CJ, Flaig TW. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302. Eur Urol. 2017 Apr;71(4):656-664. doi: 10.1016/j.eururo.2016.06.033. Epub 2016 Jul 9.

Fizazi K, Flaig TW, Stöckle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.

Saad F, Shore N, Van Poppel H, Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Griffin TA, De Porre P, Londhe A, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ. Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302. Eur Urol. 2015 Oct;68(4):570-7. doi: 10.1016/j.eururo.2015.04.032. Epub 2015 May 16.

Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.

Morris MJ, Molina A, Small EJ, de Bono JS, Logothetis CJ, Fizazi K, de Souza P, Kantoff PW, Higano CS, Li J, Kheoh T, Larson SM, Matheny SL, Naini V, Burzykowski T, Griffin TW, Scher HI, Ryan CJ. Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA-302 results. J Clin Oncol. 2015 Apr 20;33(12):1356-63. doi: 10.1200/JCO.2014.55.3875. Epub 2015 Jan 26.

Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16.

Attard G, de Bono JS, Logothetis CJ, Fizazi K, Mukherjee SD, Joshua AM, Schrijvers D, van den Eertwegh AJ, Li W, Molina A, Griffin TW, Kheoh T, Ricci DS, Zelinsky K, Rathkopf DE, Scher HI, Ryan CJ. Improvements in Radiographic Progression-Free Survival Stratified by ERG Gene Status in Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone Acetate. Clin Cancer Res. 2015 Apr 1;21(7):1621-7. doi: 10.1158/1078-0432.CCR-14-1961. Epub 2015 Jan 15.

Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28.

Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6.

Basch E, Autio K, Ryan CJ, Mulders P, Shore N, Kheoh T, Fizazi K, Logothetis CJ, Rathkopf D, Smith MR, Mainwaring PN, Hao Y, Griffin T, Li S, Meyers ML, Molina A, Cleeland C. Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1193-9. doi: 10.1016/S1470-2045(13)70424-8. Epub 2013 Sep 25.

Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. Erratum in: N Engl J Med. 2013 Feb 7;368(6):584.

Layout table for additonal information

Responsible Party:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT00887198
Other Study ID Numbers:	CR016927 COU-AA-302 ( Other Identifier: Janssen Research & Development, LLC ) 2008-008004-41 ( EudraCT Number )
First Submitted:	April 18, 2009
First Posted:	April 23, 2009
Results First Submitted:	March 30, 2015
Results First Posted:	April 9, 2015
Last Update Posted:	June 25, 2018

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