To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

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ClinicalTrials.gov Identifier: NCT00715078

Recruitment Status : Completed

First Posted : July 15, 2008

Results First Posted : May 12, 2014

Last Update Posted : May 23, 2017

Sponsor:

Information provided by (Responsible Party):

Dendreon

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
Condition	Prostate Cancer
Intervention	Biological: sipuleucel-T
Enrollment	122

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Cohort A	Cohort B	Cohort C
Arm/Group Description	Sipuleucel-T with the concentration...	Sipuleucel-T with the concentration...	Sipuleucel-T with the concentration...
Arm/Group Description	Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Period Title: Overall Study
Started	41	40	41
Received ≥ 1 Study Infusion	40	40	39
Received ≥ 1 Leukapheresis	40	40	40
Completed	11	4	3
Not Completed	30	36	38
Reason Not Completed
Death	29	36	36
Withdrawal by Subject	1	0	1
Unable to start due to disease prog.	0	0	1

Baseline Characteristics

Arm/Group Title		Cohort A	Cohort B	Cohort C	Total
Arm/Group Description		Sipuleucel-T with the concentration...	Sipuleucel-T with the concentration...	Sipuleucel-T with the concentration...	Total of all reporting groups
Arm/Group Description		Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Total of all reporting groups
Overall Number of Baseline Participants		41	40	41	122
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	40 participants	41 participants	122 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	11 26.8%	9 22.5%	11 26.8%	31 25.4%
	>=65 years	30 73.2%	31 77.5%	30 73.2%	91 74.6%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	41 participants	40 participants	41 participants	122 participants
		71.0 (8.25)	71.8 (8.29)	68.6 (7.5)	70.5 (8.07)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	40 participants	41 participants	122 participants
	Female	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Male	41 100.0%	40 100.0%	41 100.0%	122 100.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	40 participants	41 participants	122 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	5 12.5%	0 0.0%	5 4.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	3 7.3%	0 0.0%	3 7.3%	6 4.9%
	White	38 92.7%	35 87.5%	38 92.7%	111 91.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	41 participants	40 participants	41 participants	122 participants
United States		41 100.0%	40 100.0%	41 100.0%	122 100.0%
Eastern Cooperative Oncology Group (ECOG) performance status ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	41 participants	40 participants	41 participants	122 participants
ECOG 0=Fully Active; No restrictions		29 70.7%	24 60.0%	27 65.9%	80 65.6%
ECOG 1= Restricted Strenuous Activity		12 29.3%	16 40.0%	14 34.1%	42 34.4%
		[1] Measure Description: ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead
Gleason Score ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	41 participants	40 participants	41 participants	122 participants
Gleason Score ≤ 6		7 17.1%	8 20.0%	4 9.8%	19 15.6%
Gleason Score =7		12 29.3%	15 37.5%	14 34.1%	41 33.6%
Gleason Score ≥ 8		22 53.7%	16 40.0%	23 56.1%	61 50.0%
Missing information		0 0.0%	1 2.5%	0 0.0%	1 0.8%
		[1] Measure Description: Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread.

Outcome Measures

1.Primary Outcome


Title	Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.
Description	An analysis of variance model for the log transformed cumulative CD54 ...
Description	An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.
Time Frame	Baseline, Months 2, 4 and 6.

Outcome Measure Data

Analysis Population Description

Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject.


Arm/Group Title	Cohort A	Cohort B	Cohort C
Arm/Group Description:	Sipuleucel-T with the concentration...	Sipuleucel-T with the concentration...	Sipuleucel-T with the concentration...
Arm/Group Description:	Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Overall Number of Participants Analyzed	40	36	37
Mean (Standard Error) Unit of Measure: Ratio ofCD54 molecules on BDS65:FP cells
	29.53 (1.285)	30.94 (1.418)	26.67 (1.194)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort A, Cohort B
	Comments	The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Cohort B is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval (CI) for the ratio of Cohort B vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is >0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of <20% in upregulation ratios may not be clinically significant.

Statistical Test of Hypothesis	P-Value	0.5019
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	ratio of geometric means (GeoMean)
	Estimated Value	1.046
	Confidence Interval	(2-Sided) 90% 0.936 to 1.168
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort A, Cohort C
	Comments	The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Cohort C is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval for the ratio of Cohort C vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is >0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of <20% in upregulation ratios may not be clinically significant.

Statistical Test of Hypothesis	P-Value	0.1443
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	the ratio of geometric means
	Estimated Value	0.907
	Confidence Interval	(2-Sided) 90% 0.813 to 1.013
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first.
Adverse Event Reporting Description	Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.

Arm/Group Title	Cohort A		Cohort B		Cohort C
Arm/Group Description	Sipuleucel-T with the concentration...		Sipuleucel-T with the concentration...		Sipuleucel-T with the concentration...
Arm/Group Description	Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL		Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL		Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
All-Cause Mortality
	Cohort A		Cohort B		Cohort C
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	29/40 (72.50%)		36/40 (90.00%)		36/40 (90.00%)
Serious Adverse Events Serious Adverse Events
	Cohort A		Cohort B		Cohort C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/40 (25.00%)		9/40 (22.50%)		11/40 (27.50%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	0/40 (0.00%)	0	3/40 (7.50%)	3	0/40 (0.00%)	0
DISSEMINATED INTRAVASCULAR COAGULATION ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
ANGINA PECTORIS ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	2	0/40 (0.00%)	0
ATRIAL FIBRILLATION ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	1/40 (2.50%)	1
ATRIOVENTRICULAR BLOCK COMPLETE ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
ATRIOVENTRICULAR BLOCK SECOND DEGREE ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
BRADYCARDIA ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
CARDIAC FAILURE CONGESTIVE ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
CARDIO-RESPIRATORY ARREST ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
CORONARY ARTERY DISEASE ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
Ear and labyrinth disorders
VERTIGO ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
Gastrointestinal disorders
ILEUS ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
General disorders
ASTHENIA ^† 1	3/40 (7.50%)	3	1/40 (2.50%)	1	0/40 (0.00%)	0
CHILLS ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
DISEASE PROGRESSION ^† 1	1/40 (2.50%)	1	1/40 (2.50%)	1	1/40 (2.50%)	1
FATIGUE ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	2/40 (5.00%)	2
NON-CARDIAC CHEST PAIN ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
PYREXIA ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
Infections and infestations
BACTERAEMIA ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
DEVICE RELATED INFECTION ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
PNEUMONIA ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
SEPSIS ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
URINARY TRACT INFECTION ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	1/40 (2.50%)	1
UROSEPSIS ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
HIP FRACTURE ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	1/40 (2.50%)	1
WOUND ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
Metabolism and nutrition disorders
DEHYDRATION ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	1/40 (2.50%)	1
HYPERGLYCAEMIA ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
HYPOCALCAEMIA ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
HYPONATRAEMIA ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
Nervous system disorders
CEREBRAL INFARCTION ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	1/40 (2.50%)	1
CEREBROVASCULAR ACCIDENT ^† 1	1/40 (2.50%)	1	1/40 (2.50%)	1	2/40 (5.00%)	2
INTRACRANIAL TUMOUR HAEMORRHAGE ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
SPINAL CORD COMPRESSION ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
SYNCOPE ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	1/40 (2.50%)	1
TRANSIENT ISCHAEMIC ATTACK ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	2	1/40 (2.50%)	1
Psychiatric disorders
CONFUSIONAL STATE ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
Renal and urinary disorders
BLADDER OUTLET OBSTRUCTION ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
HYDRONEPHROSIS ^† 1	1/40 (2.50%)	1	2/40 (5.00%)	2	0/40 (0.00%)	0
RENAL FAILURE ACUTE ^† 1	1/40 (2.50%)	1	1/40 (2.50%)	1	0/40 (0.00%)	0
URETHRAL STENOSIS ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	0/40 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	1/40 (2.50%)	2
DYSPNOEA ^† 1	1/40 (2.50%)	2	0/40 (0.00%)	0	0/40 (0.00%)	0
HYPOXIA ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
Vascular disorders
DEEP VEIN THROMBOSIS ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	0/40 (0.00%)	0
1 Term from vocabulary, MedDRA 14.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cohort A		Cohort B		Cohort C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/40 (95.00%)		40/40 (100.00%)		40/40 (100.00%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	6/40 (15.00%)	6	4/40 (10.00%)	5	8/40 (20.00%)	8
Gastrointestinal disorders
ABDOMINAL DISCOMFORT ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	2/40 (5.00%)	2
ABDOMINAL PAIN ^† 1	4/40 (10.00%)	4	2/40 (5.00%)	3	3/40 (7.50%)	3
ABDOMINAL PAIN UPPER ^† 1	2/40 (5.00%)	2	2/40 (5.00%)	2	2/40 (5.00%)	3
CONSTIPATION ^† 1	9/40 (22.50%)	10	8/40 (20.00%)	9	6/40 (15.00%)	7
DIARRHOEA ^† 1	4/40 (10.00%)	5	4/40 (10.00%)	4	3/40 (7.50%)	3
DYSPEPSIA ^† 1	4/40 (10.00%)	4	2/40 (5.00%)	2	0/40 (0.00%)	0
DYSPHAGIA ^† 1	2/40 (5.00%)	2	0/40 (0.00%)	0	0/40 (0.00%)	0
FLATULENCE ^† 1	1/40 (2.50%)	1	2/40 (5.00%)	2	0/40 (0.00%)	0
GASTROOESOPHAGEAL REFLUX DISEASE ^† 1	2/40 (5.00%)	2	1/40 (2.50%)	1	0/40 (0.00%)	0
NAUSEA ^† 1	16/40 (40.00%)	20	11/40 (27.50%)	11	11/40 (27.50%)	12
RETCHING ^† 1	2/40 (5.00%)	2	1/40 (2.50%)	1	0/40 (0.00%)	0
VOMITING ^† 1	8/40 (20.00%)	9	5/40 (12.50%)	5	5/40 (12.50%)	6
PARAESTHESIA ORAL ^* 2	2/40 (5.00%)	4	3/40 (7.50%)	5	5/40 (12.50%)	9
HYPOAESTHESIA ORAL ^* 1	3/40 (7.50%)	3	1/40 (2.50%)	1	2/40 (5.00%)	2
General disorders
ASTHENIA ^† 1	2/40 (5.00%)	2	3/40 (7.50%)	3	4/40 (10.00%)	5
CHEST DISCOMFORT ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	2/40 (5.00%)	2
CHEST PAIN ^† 1	6/40 (15.00%)	6	0/40 (0.00%)	0	2/40 (5.00%)	2
CHILLS ^† 1	9/40 (22.50%)	15	13/40 (32.50%)	25	10/40 (25.00%)	15
FATIGUE ^† 1	20/40 (50.00%)	23	20/40 (50.00%)	27	16/40 (40.00%)	17
INFLUENZA LIKE ILLNESS ^† 1	4/40 (10.00%)	6	0/40 (0.00%)	0	4/40 (10.00%)	6
MALAISE ^† 1	1/40 (2.50%)	2	0/40 (0.00%)	0	2/40 (5.00%)	2
OEDEMA PERIPHERAL ^† 1	6/40 (15.00%)	6	9/40 (22.50%)	10	4/40 (10.00%)	5
PAIN ^† 1	0/40 (0.00%)	0	4/40 (10.00%)	6	1/40 (2.50%)	1
PYREXIA ^† 1	5/40 (12.50%)	6	4/40 (10.00%)	5	7/40 (17.50%)	8
Infections and infestations
BRONCHITIS ^† 1	0/40 (0.00%)	0	1/40 (2.50%)	1	2/40 (5.00%)	2
GASTROENTERITIS VIRAL ^† 1	2/40 (5.00%)	2	0/40 (0.00%)	0	0/40 (0.00%)	0
NASOPHARYNGITIS ^† 1	3/40 (7.50%)	3	3/40 (7.50%)	3	1/40 (2.50%)	1
PNEUMONIA ^† 1	0/40 (0.00%)	0	2/40 (5.00%)	2	2/40 (5.00%)	2
UPPER RESPIRATORY TRACT INFECTION ^† 1	2/40 (5.00%)	3	2/40 (5.00%)	2	2/40 (5.00%)	2
URINARY TRACT INFECTION ^† 1	2/40 (5.00%)	2	5/40 (12.50%)	6	1/40 (2.50%)	1
VIRAL INFECTION ^† 1	2/40 (5.00%)	2	0/40 (0.00%)	0	0/40 (0.00%)	0
Injury, poisoning and procedural complications
CITRATE TOXICITY ^† 1	5/40 (12.50%)	10	4/40 (10.00%)	7	6/40 (15.00%)	13
CONTUSION ^† 1	3/40 (7.50%)	3	2/40 (5.00%)	2	1/40 (2.50%)	1
FALL ^† 1	2/40 (5.00%)	2	1/40 (2.50%)	1	2/40 (5.00%)	4
LACERATION ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	2/40 (5.00%)	3
Investigations
BLOOD PRESSURE INCREASED ^† 1	2/40 (5.00%)	2	1/40 (2.50%)	1	2/40 (5.00%)	7
WEIGHT DECREASED ^† 1	7/40 (17.50%)	7	5/40 (12.50%)	5	3/40 (7.50%)	3
Metabolism and nutrition disorders
DECREASED APPETITE ^† 1	7/40 (17.50%)	8	10/40 (25.00%)	10	8/40 (20.00%)	8
DEHYDRATION ^† 1	8/40 (20.00%)	12	4/40 (10.00%)	8	4/40 (10.00%)	6
HYPOKALAEMIA ^† 1	0/40 (0.00%)	0	0/40 (0.00%)	0	2/40 (5.00%)	2
HYPONATRAEMIA ^† 1	0/40 (0.00%)	0	2/40 (5.00%)	2	0/40 (0.00%)	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	11/40 (27.50%)	16	13/40 (32.50%)	19	7/40 (17.50%)	13
BACK PAIN ^† 1	10/40 (25.00%)	15	16/40 (40.00%)	21	12/40 (30.00%)	16
BONE PAIN ^† 1	3/40 (7.50%)	3	0/40 (0.00%)	0	5/40 (12.50%)	5
FLANK PAIN ^† 1	4/40 (10.00%)	5	4/40 (10.00%)	4	1/40 (2.50%)	1
GROIN PAIN ^† 1	1/40 (2.50%)	1	1/40 (2.50%)	1	2/40 (5.00%)	2
MUSCLE SPASMS ^† 1	4/40 (10.00%)	4	6/40 (15.00%)	7	2/40 (5.00%)	2
MUSCULAR WEAKNESS ^† 1	0/40 (0.00%)	0	3/40 (7.50%)	3	2/40 (5.00%)	2
MUSCULOSKELETAL CHEST PAIN ^† 1	4/40 (10.00%)	4	1/40 (2.50%)	1	1/40 (2.50%)	1
MUSCULOSKELETAL DISCOMFORT ^† 1	1/40 (2.50%)	1	2/40 (5.00%)	3	0/40 (0.00%)	0
MUSCULOSKELETAL PAIN ^† 1	8/40 (20.00%)	9	4/40 (10.00%)	5	12/40 (30.00%)	13
MYALGIA ^† 1	7/40 (17.50%)	8	5/40 (12.50%)	5	4/40 (10.00%)	5
NECK PAIN ^† 1	2/40 (5.00%)	2	0/40 (0.00%)	0	1/40 (2.50%)	1
PAIN IN EXTREMITY ^† 1	6/40 (15.00%)	8	3/40 (7.50%)	6	9/40 (22.50%)	9
Nervous system disorders
DIZZINESS ^† 1	6/40 (15.00%)	7	6/40 (15.00%)	6	8/40 (20.00%)	11
DYSGEUSIA ^† 1	2/40 (5.00%)	2	0/40 (0.00%)	0	2/40 (5.00%)	2
HEADACHE ^† 1	4/40 (10.00%)	5	3/40 (7.50%)	3	7/40 (17.50%)	8
HYPOAESTHESIA ^† 1	1/40 (2.50%)	1	5/40 (12.50%)	11	1/40 (2.50%)	1
PARAESTHESIA ^† 1	3/40 (7.50%)	3	9/40 (22.50%)	12	5/40 (12.50%)	5
RESTLESS LEGS SYNDROME ^† 1	1/40 (2.50%)	1	2/40 (5.00%)	3	2/40 (5.00%)	3
SOMNOLENCE ^† 1	2/40 (5.00%)	2	0/40 (0.00%)	0	1/40 (2.50%)	1
TREMOR ^† 1	2/40 (5.00%)	2	1/40 (2.50%)	1	2/40 (5.00%)	2
Psychiatric disorders
AGITATION ^† 1	0/40 (0.00%)	0	2/40 (5.00%)	2	2/40 (5.00%)	2
ANXIETY ^† 1	3/40 (7.50%)	4	6/40 (15.00%)	7	3/40 (7.50%)	3
DEPRESSION ^† 1	5/40 (12.50%)	5	1/40 (2.50%)	1	3/40 (7.50%)	3
INSOMNIA ^† 1	3/40 (7.50%)	3	5/40 (12.50%)	5	6/40 (15.00%)	6
Renal and urinary disorders
HAEMATURIA ^† 1	5/40 (12.50%)	6	4/40 (10.00%)	6	1/40 (2.50%)	1
HYDRONEPHROSIS ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	2/40 (5.00%)	2
NEPHROLITHIASIS ^† 1	2/40 (5.00%)	2	0/40 (0.00%)	0	0/40 (0.00%)	0
NOCTURIA ^† 1	2/40 (5.00%)	2	5/40 (12.50%)	5	2/40 (5.00%)	2
POLLAKIURIA ^† 1	1/40 (2.50%)	1	4/40 (10.00%)	4	0/40 (0.00%)	0
URINARY RETENTION ^† 1	0/40 (0.00%)	0	3/40 (7.50%)	3	3/40 (7.50%)	3
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	4/40 (10.00%)	4	2/40 (5.00%)	2	3/40 (7.50%)	3
DYSPNOEA ^† 1	3/40 (7.50%)	3	4/40 (10.00%)	4	3/40 (7.50%)	3
DYSPNOEA EXERTIONAL ^† 1	1/40 (2.50%)	1	2/40 (5.00%)	2	3/40 (7.50%)	3
PRODUCTIVE COUGH ^† 1	2/40 (5.00%)	2	0/40 (0.00%)	0	0/40 (0.00%)	0
Skin and subcutaneous tissue disorders
ECCHYMOSIS ^† 1	3/40 (7.50%)	4	1/40 (2.50%)	1	0/40 (0.00%)	0
HYPERHIDROSIS ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	2/40 (5.00%)	2
RASH ^† 1	1/40 (2.50%)	1	2/40 (5.00%)	2	2/40 (5.00%)	2
Vascular disorders
HAEMATOMA ^† 1	3/40 (7.50%)	3	2/40 (5.00%)	2	0/40 (0.00%)	0
HOT FLUSH ^† 1	1/40 (2.50%)	1	1/40 (2.50%)	1	2/40 (5.00%)	3
HYPERTENSION ^† 1	3/40 (7.50%)	6	4/40 (10.00%)	5	2/40 (5.00%)	2
HYPOTENSION ^† 1	1/40 (2.50%)	1	0/40 (0.00%)	0	4/40 (10.00%)	4
1 Term from vocabulary, MedDRA 14.1 2 Term from vocabulary, MedDRA † Indicates events were collected by systematic assessment * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

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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.

The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.

Results Point of Contact

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Name/Title:	Shabnam Vaziri
Organization:	Dendreon
Phone:	206-455-2323
EMail:	Svaziri@Dendreon.com

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Responsible Party:	Dendreon
ClinicalTrials.gov Identifier:	NCT00715078
Other Study ID Numbers:	P07-2
First Submitted:	July 11, 2008
First Posted:	July 15, 2008
Results First Submitted:	February 19, 2014
Results First Posted:	May 12, 2014
Last Update Posted:	May 23, 2017

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