Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02111577

Recruitment Status : Completed

First Posted : April 11, 2014

Results First Posted : April 6, 2021

Last Update Posted : April 6, 2021

Sponsor:

Information provided by (Responsible Party):

Sotio a.s.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition	Metastatic Castration-resistant Prostate Cancer
Interventions	Biological: DCVAC/PCa Biological: Placebo
Enrollment	1182

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description	Combination therapy with dendritic ...	Combination therapy with placebo an...
Arm/Group Description	Combination therapy with dendritic cell vaccine for prostate cancer (DCVAC/PCa) and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Period Title: Overall Study
Started	787	395
Completed	188	106
Not Completed	599	289
Reason Not Completed
Protocol Violation	2	0
Unable to tolerate leukapheresis	1	0
Failure to produce study treatment	6	0
Death	518	254
Medical monitor's decision (active hepatitis B)	1	0
Adverse Event	1	1
Withdrawal by Subject	51	23
Disease progression	0	1
Lost to Follow-up	19	10

Baseline Characteristics

Arm/Group Title		DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy	Total
Arm/Group Description		Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...	Total of all reporting groups
Arm/Group Description		Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator	Total of all reporting groups
Overall Number of Baseline Participants		787	395	1182
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	787 participants	395 participants	1182 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	272 34.6%	107 27.1%	379 32.1%
	>=65 years	515 65.4%	288 72.9%	803 67.9%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	787 participants	395 participants	1182 participants
		68.0 (46 to 89)	69.0 (46 to 89)	68.0 (46 to 89)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	787 participants	395 participants	1182 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	787 100.0%	395 100.0%	1182 100.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	787 participants	395 participants	1182 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	5 0.6%	4 1.0%	9 0.8%
	Native Hawaiian or Other Pacific Islander	1 0.1%	0 0.0%	1 0.1%
	Black or African American	26 3.3%	19 4.8%	45 3.8%
	White	733 93.1%	358 90.6%	1091 92.3%
	More than one race	4 0.5%	3 0.8%	7 0.6%
	Unknown or Not Reported	18 2.3%	11 2.8%	29 2.5%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Hungary	Number Analyzed	787 participants	395 participants	1182 participants
Hungary		28	14	42
United States	Number Analyzed	787 participants	395 participants	1182 participants
United States		144	73	217
Czechia	Number Analyzed	787 participants	395 participants	1182 participants
Czechia		102	40	142
United Kingdom	Number Analyzed	787 participants	395 participants	1182 participants
United Kingdom		60	36	96
Belarus	Number Analyzed	787 participants	395 participants	1182 participants
Belarus		13	18	31
Portugal	Number Analyzed	787 participants	395 participants	1182 participants
Portugal		20	10	30
Spain	Number Analyzed	787 participants	395 participants	1182 participants
Spain		18	14	32
Austria	Number Analyzed	787 participants	395 participants	1182 participants
Austria		14	5	19
Latvia	Number Analyzed	787 participants	395 participants	1182 participants
Latvia		0	2	2
Netherlands	Number Analyzed	787 participants	395 participants	1182 participants
Netherlands		29	19	48
Sweden	Number Analyzed	787 participants	395 participants	1182 participants
Sweden		4	1	5
Belgium	Number Analyzed	787 participants	395 participants	1182 participants
Belgium		20	11	31
Denmark	Number Analyzed	787 participants	395 participants	1182 participants
Denmark		2	0	2
Poland	Number Analyzed	787 participants	395 participants	1182 participants
Poland		94	36	130
Italy	Number Analyzed	787 participants	395 participants	1182 participants
Italy		19	3	22
Slovakia	Number Analyzed	787 participants	395 participants	1182 participants
Slovakia		49	15	64
Bulgaria	Number Analyzed	787 participants	395 participants	1182 participants
Bulgaria		15	10	25
France	Number Analyzed	787 participants	395 participants	1182 participants
France		18	12	30
Lithuania	Number Analyzed	787 participants	395 participants	1182 participants
Lithuania		6	5	11
Serbia	Number Analyzed	787 participants	395 participants	1182 participants
Serbia		22	14	36
Germany	Number Analyzed	787 participants	395 participants	1182 participants
Germany		92	51	143
Croatia	Number Analyzed	787 participants	395 participants	1182 participants
Croatia		18	6	24
Prostate-specific antigen ^[1] Median (Full Range) Unit of measure: ng/L
	Number Analyzed	786 participants	394 participants	1180 participants
		46.35 (0.0 to 7500.0)	54.02 (0.1 to 5000.0)	47.87 (0.0 to 7500.0)
		[1] Measure Analysis Population Description: PSA available for 786 patients in the experimental arm (DCVAC/PCa) and 394 patients in the control arm (placebo)

Outcome Measures

1.Primary Outcome


Title	Overall Survival, Intention-to-treat Population
Description	Overall survival is defined as the time from randomization until death...
Description	Overall survival is defined as the time from randomization until death due to any cause.
Time Frame	From randomization to death due to any cause, up to 58 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone) DCVAC/PCa: DCVAC/PCa concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). DCVAC/PCa was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of DCVAC/PCa was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator Placebo: Placebo concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). Placebo was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of placebo was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.
Overall Number of Participants Analyzed	787	395
Median (95% Confidence Interval) Unit of Measure: Months
	23.9 (21.6 to 25.3)	24.3 (22.6 to 26.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and Eastern Cooperative Oncology Group (ECOG) score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.596
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.042
	Confidence Interval	(2-Sided) 95% 0.895 to 1.213
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.648
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.036
	Confidence Interval	(2-Sided) 95% 0.891 to 1.204
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival, Per Protocol Population
Description	Overall survival is defined as the time from randomization until death...
Description	Overall survival is defined as the time from randomization until death due to any cause.
Time Frame	From randomization to death due to any cause, up to 58 months

Outcome Measure Data

Analysis Population Description

Per protocol population definition:

A subset of all randomized patients characterized by the following criteria:

had at least 1 post-baseline efficacy assessment
did not have any major protocol violation that would affect the endpoints being assessed
received at least 8 doses of DCVAC/PCa or placebo


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	438	284
Median (95% Confidence Interval) Unit of Measure: Months
	29.7 (26.9 to 32.3)	26.7 (24.7 to 28.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.335
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.908
	Confidence Interval	(2-Sided) 95% 0.746 to 1.105
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.192
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.879
	Confidence Interval	(2-Sided) 95% 0.725 to 1.067
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy
Description	Overall survival is defined as the time from randomization until death...
Description	Overall survival is defined as the time from randomization until death due to any cause.
Time Frame	From randomization to death due to any cause, up to 58 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients with abiraterone as prior therapy


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	187	103
Median (95% Confidence Interval) Unit of Measure: Months
	16.6 (14.9 to 19.7)	21.0 (16.6 to 24.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.071
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.312
	Confidence Interval	(2-Sided) 95% 0.976 to 1.762
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.09
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.283
	Confidence Interval	(2-Sided) 95% 0.961 to 1.712
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy
Description	Overall survival is defined as the time from randomization until death...
Description	Overall survival is defined as the time from randomization until death due to any cause.
Time Frame	From randomization to death due to any cause, up to 58 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients with enzalutamide as prior therapy


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	137	60
Median (95% Confidence Interval) Unit of Measure: Months
	15.2 (13.3 to 18.3)	21.4 (15.1 to 26.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.049
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.461
	Confidence Interval	(2-Sided) 95% 1 to 2.134
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.053
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.436
	Confidence Interval	(2-Sided) 95% 0.993 to 2.077
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide
Description	Overall survival is defined as the time from randomization until death...
Description	Overall survival is defined as the time from randomization until death due to any cause.
Time Frame	From randomization to death due to any cause, up to 58 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients with neither abiraterone nor enzalutamide as prior therapy


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	546	271
Median (95% Confidence Interval) Unit of Measure: Months
	26.7 (25.2 to 28.8)	25.7 (23.8 to 28.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.501
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.938
	Confidence Interval	(2-Sided) 95% 0.779 to 1.13
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.512
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95% 0.781 to 1.131
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Radiological Progression-free Survival, Intention-to-treat Population
Description	Progressive disease on bone scans was defined as a minimum of two new ...
Description	Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Time Frame	Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	787	395
Median (95% Confidence Interval) Unit of Measure: Months
	11.1 (11.0 to 11.4)	11.1 (10.8 to 11.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.886
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95% 0.863 to 1.136
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.992
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.001
	Confidence Interval	(2-Sided) 95% 0.875 to 1.145
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Radiological Progression-free Survival, Per Protocol Population
Description	Progressive disease on bone scans was defined as a minimum of two new ...
Description	Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Time Frame	Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months

Outcome Measure Data

Analysis Population Description

Per protocol population definition:

A subset of all randomized patients characterized by the following criteria:

had at least 1 post-baseline efficacy assessment
did not have any major protocol violation that would affect the endpoints being assessed
received at least 8 doses of DCVAC/PCa or placebo


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	438	284
Median (95% Confidence Interval) Unit of Measure: Months
	11.2 (11.1 to 11.7)	11.2 (11.0 to 11.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.994
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.001
	Confidence Interval	(2-Sided) 95% 0.847 to 1.184
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.982
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.002
	Confidence Interval	(2-Sided) 95% 0.851 to 1.18
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Time to PSA Progression, Intention-to-treat Population
Description	The evidence of PSA progression is defined as: time from randomization...
Description	The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.
Time Frame	Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	787	395
Median (95% Confidence Interval) Unit of Measure: Months
	10.5 (9.7 to 10.6)	10.6 (10.4 to 10.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.392
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.077
	Confidence Interval	(2-Sided) 95% 0.909 to 1.277
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.439
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.068
	Confidence Interval	(2-Sided) 95% 0.905 to 1.262
	Estimation Comments	[Not Specified]

9.Secondary Outcome


Title	Time to PSA Progression, Per Protocol Population
Description	The evidence of PSA progression is defined as: time from randomization...
Description	The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.
Time Frame	Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months

Outcome Measure Data

Analysis Population Description

Per protocol population definition:

A subset of all randomized patients characterized by the following criteria:

had at least 1 post-baseline efficacy assessment
did not have any major protocol violation that would affect the endpoints being assessed
received at least 8 doses of DCVAC/PCa or placebo


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	438	284
Median (95% Confidence Interval) Unit of Measure: Months
	10.5 (10.4 to 10.7)	10.6 (10.4 to 10.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.754
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95% 0.857 to 1.238
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.924
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.009
	Confidence Interval	(2-Sided) 95% 0.844 to 1.207
	Estimation Comments	[Not Specified]

10.Secondary Outcome


Title	Time to First Skeletal-related Event, Intention-to-treat Population
Description	Skeletal-related events included: ...
Description	Skeletal-related events included: Radiation therapy to bone Pathologic bone fracture Spinal cord compression Surgery to bone Change in antineoplastic therapy to treat bone pain
Time Frame	Time from randomization to the date of the first skeletal-related event, up to 58 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	787	395
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Not reached; insufficient number of participants with events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.732
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.918
	Confidence Interval	(2-Sided) 95% 0.563 to 1.497
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.713
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.913
	Confidence Interval	(2-Sided) 95% 0.561 to 1.485
	Estimation Comments	[Not Specified]

11.Secondary Outcome


Title	Time to First Skeletal-related Event, Per Protocol Population
Description	Skeletal-related events included: ...
Description	Skeletal-related events included: Radiation therapy to bone Pathologic bone fracture Spinal cord compression Surgery to bone Change in antineoplastic therapy to treat bone pain
Time Frame	Time from randomization to the date of the first skeletal-related event, up to 58 months

Outcome Measure Data

Analysis Population Description

Per protocol population definition:

A subset of all randomized patients characterized by the following criteria:

had at least 1 post-baseline efficacy assessment
did not have any major protocol violation that would affect the endpoints being assessed
received at least 8 doses of DCVAC/PCa or placebo


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	438	284
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Not reached; insufficient number of participants with events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.694
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.891
	Confidence Interval	(2-Sided) 95% 0.5 to 1.587
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.661
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95% 0.496 to 1.562
	Estimation Comments	[Not Specified]

12.Secondary Outcome


Title	Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population
Description	Progressive disease on bone scans defined as a minimum of two new lesi...
Description	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. Skeletal-related events included: Radiation therapy to bone Pathologic bone fracture Spinal cord compression Surgery to bone Change in antineoplastic therapy to treat bone pain
Time Frame	Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	787	395
Median (95% Confidence Interval) Unit of Measure: Months
	11.1 (10.9 to 11.3)	10.9 (10.5 to 11.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.111
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.895
	Confidence Interval	(2-Sided) 95% 0.781 to 1.027
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.184
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.913
	Confidence Interval	(2-Sided) 95% 0.798 to 1.044
	Estimation Comments	[Not Specified]

13.Secondary Outcome


Title	Time to Radiological Progression or Skeletal-related Event, Per Protocol Population
Description	Progressive disease on bone scans defined as a minimum of two new lesi...
Description	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. Skeletal-related events included: Radiation therapy to bone Pathologic bone fracture Spinal cord compression Surgery to bone Change in antineoplastic therapy to treat bone pain
Time Frame	Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months

Outcome Measure Data

Analysis Population Description

A subset of all randomized patients characterized by the following criteria:

had at least 1 post-baseline efficacy assessment
did not have any major protocol violation that would affect the endpoints being assessed
received at least 8 doses of DCVAC/PCa or placebo


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	438	284
Median (95% Confidence Interval) Unit of Measure: Months
	11.1 (11.0 to 11.5)	11.1 (10.8 to 11.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.46
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.939
	Confidence Interval	(2-Sided) 95% 0.795 to 1.11
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Unstratified
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.534
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95% 0.807 to 1.118
	Estimation Comments	[Not Specified]

14.Secondary Outcome


Title	Proportion of Patients With Skeletal-related Events, Intention-to-treat Population
Description	Progressive disease on bone scans defined as a minimum of two new lesi...
Description	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. Skeletal-related events included: Radiation therapy to bone Pathologic bone fracture Spinal cord compression Surgery to bone Change in antineoplastic therapy to treat bone pain
Time Frame	From randomization to the end of the study, up to 57 months

Outcome Measure Data

Analysis Population Description

Intention-to-treat population definition: All randomized patients


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	787	395
Measure Type: Number Unit of Measure: Patients
	43	26

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.485
	Comments	[Not Specified]
	Method	Log binomial model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.845
	Confidence Interval	(2-Sided) 95% 0.528 to 1.355
	Estimation Comments	[Not Specified]

15.Secondary Outcome


Title	Proportion of Patients With Skeletal-related Events, Per Protocol Population
Description	Progressive disease on bone scans defined as a minimum of two new lesi...
Description	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. Skeletal-related events included: Radiation therapy to bone Pathologic bone fracture Spinal cord compression Surgery to bone Change in antineoplastic therapy to treat bone pain
Time Frame	From randomization to the end of the study, up to 57 months

Outcome Measure Data

Analysis Population Description

A subset of all randomized patients characterized by the following criteria:

had at least 1 post-baseline efficacy assessment
did not have any major protocol violation that would affect the endpoints being assessed
received at least 8 doses of DCVAC/PCa or placebo


Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy	Placebo With Standard of Care Chemotherapy
Arm/Group Description:	Combination therapy with DCVAC/PCa ...	Combination therapy with placebo an...
Arm/Group Description:	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed	438	284
Measure Type: Number Unit of Measure: Patients
	28	20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
	Comments	Stratified
	Type of Statistical Test	Superiority
	Comments	Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)

Statistical Test of Hypothesis	P-Value	0.768
	Comments	[Not Specified]
	Method	Log binomial model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95% 0.529 to 1.601
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Up to 68 months. Adverse events (AEs) occurring after signing the informed consent until 30 days after the last dose of DCVAC/PCa or placebo were collected. Treatment-emergent AEs: Start date on or after the earliest start of chemotherapy or study treatment or adverse event worsened (increased in severity) on or after the earliest start of chemotherapy or study treatment. Deaths: From consent signature to study end.
Adverse Event Reporting Description	Mortality: in all randomized patients. AEs: in the safety population (received chemotherapy and/or at least 1 dose of DCVAC/PCa or placebo). At each contact, open-ended and non-leading verbal questioning of the patient by the investigator was used to inquire about AEs. Causal relationship of the AE to DCVAC/PCa or placebo was assessed by investigators. Disease progression-related events (as evaluated by investigators) were excluded from serious AE reporting but were captured as non-serious AEs.

Arm/Group Title	DCVAC/PCa With Standard of Care Chemotherapy		Placebo With Standard of Care Chemotherapy
Arm/Group Description	Combination therapy with DCVAC/PCa ...		Combination therapy with placebo an...
Arm/Group Description	Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)		Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
All-Cause Mortality
	DCVAC/PCa With Standard of Care Chemotherapy		Placebo With Standard of Care Chemotherapy
	Affected / at Risk (%)		Affected / at Risk (%)
Total	518/787 (65.82%)		254/395 (64.30%)
Serious Adverse Events Serious Adverse Events
	DCVAC/PCa With Standard of Care Chemotherapy		Placebo With Standard of Care Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	237/749 (31.64%)		150/379 (39.58%)
Blood and lymphatic system disorders
Agranulocytosis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Anaemia ^† 1	9/749 (1.20%)	14	3/379 (0.79%)	3
Bicytopenia ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Febrile neutropenia ^† 1	25/749 (3.34%)	27	29/379 (7.65%)	34
Leukopenia ^† 1	2/749 (0.27%)	3	2/379 (0.53%)	2
Neutropenia ^† 1	12/749 (1.60%)	12	5/379 (1.32%)	7
Pancytopenia ^† 1	4/749 (0.53%)	4	0/379 (0.00%)	0
Cardiac disorders
Acute myocardial infarction ^† 1	0/749 (0.00%)	0	2/379 (0.53%)	2
Angina pectoris ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Aortic valve stenosis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Atrial fibrillation ^† 1	7/749 (0.93%)	8	2/379 (0.53%)	2
Atrial flutter ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Atrial tachycardia ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Atrioventricular block ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Cardiac arrest ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Cardiac failure ^† 1	2/749 (0.27%)	2	2/379 (0.53%)	2
Cardiac failure acute ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Cardiac failure congestive ^† 1	1/749 (0.13%)	1	2/379 (0.53%)	2
Cardiac failure chronic ^† 1	0/749 (0.00%)	0	2/379 (0.53%)	2
Cardiogenic shock ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Cardiomyopathy ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Coronary artery disease ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Myocardial infarction ^† 1	3/749 (0.40%)	3	1/379 (0.26%)	1
Myocarditis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Tachycardia ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Ventricular extrasystoles ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Ear and labyrinth disorders
Vertigo ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Eye disorders
Diplopia ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Retinal detachment ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Uveitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Abdominal pain upper ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Colitis ischaemic ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Constipation ^† 1	2/749 (0.27%)	2	1/379 (0.26%)	1
Diarrhoea ^† 1	5/749 (0.67%)	5	5/379 (1.32%)	6
Dysphagia ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Enterocolitis haemorrhagic ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Gastric antral vascular ectasia ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Gastric haemorrhage ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Gastric ulcer ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Gastric ulcer haemorrhage ^† 1	0/749 (0.00%)	0	2/379 (0.53%)	2
Gastric ulcer perforation ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Gastritis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Gastrointestinal haemorrhage ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Gastrointestinal inflammation ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Haematochezia ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Haemorrhoidal haemorrhage ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Ileus ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Intestinal obstruction ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Large intestine perforation ^† 1	0/749 (0.00%)	0	2/379 (0.53%)	2
Nausea ^† 1	1/749 (0.13%)	1	3/379 (0.79%)	4
Obstructive pancreatitis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Oesophagitis ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Pancreatitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Pancreatitis acute ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Peptic ulcer ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Rectal haemorrhage ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Rectal perforation ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Small intestinal haemorrhage ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Small intestinal obstruction ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Small intestinal stenosis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Stomatitis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Vomiting ^† 1	2/749 (0.27%)	2	4/379 (1.06%)	6
General disorders
Asthenia ^† 1	3/749 (0.40%)	3	1/379 (0.26%)	1
Catheter site inflammation ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Complication associated with device ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Death ^† 1	5/749 (0.67%)	5	5/379 (1.32%)	5
Fatigue ^† 1	5/749 (0.67%)	5	1/379 (0.26%)	1
General physical health deterioration ^† 1	6/749 (0.80%)	6	0/379 (0.00%)	0
Chest pain ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Non-cardiac chest pain ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Oedema peripheral ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Pyrexia ^† 1	9/749 (1.20%)	13	6/379 (1.58%)	9
Sudden death ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Systemic inflammatory response syndrome ^† 1	0/749 (0.00%)	0	3/379 (0.79%)	4
Hepatobiliary disorders
Hepatic cyst ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Hepatic failure ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Immune system disorders
Allergy to arthropod sting ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Anaphylactic reaction ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Hypersensitivity ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Infections and infestations
Abdominal infection ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Abscess limb ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Abscess oral ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Abscess soft tissue ^† 1	1/749 (0.13%)	2	0/379 (0.00%)	0
Anal abscess ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Appendicitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Biliary tract infection ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Bronchitis ^† 1	2/749 (0.27%)	2	2/379 (0.53%)	2
Catheter site cellulitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Cellulitis ^† 1	3/749 (0.40%)	3	0/379 (0.00%)	0
Cellulitis orbital ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Clostridium difficile colitis ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Clostridium difficile infection ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Complicated appendicitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Cytomegalovirus infection ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Cytomegalovirus oesophagitis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Dermo-hypodermitis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Device related infection ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Device related sepsis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Diverticulitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Enterococcal bacteraemia ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Enterocolitis infectious ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Erysipelas ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Escherichia sepsis ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Gastroenteritis ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Gastroenteritis norovirus ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Gastroenteritis viral ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Herpes zoster ^† 1	0/749 (0.00%)	0	2/379 (0.53%)	2
Cholangitis infective ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Infection ^† 1	3/749 (0.40%)	3	1/379 (0.26%)	1
Influenza ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Lower respiratory tract infection ^† 1	0/749 (0.00%)	0	2/379 (0.53%)	2
Neutropenic sepsis ^† 1	7/749 (0.93%)	7	5/379 (1.32%)	7
Osteomyelitis ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Paraspinal abscess ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Perirectal abscess ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Peritonitis ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Pneumonia ^† 1	18/749 (2.40%)	18	11/379 (2.90%)	13
Pneumonia mycoplasmal ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Pneumonia viral ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Pyelonephritis ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Rectal abscess ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Respiratory tract infection ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Sepsis ^† 1	8/749 (1.07%)	8	5/379 (1.32%)	5
Septic shock ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Staphylococcal abscess ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Staphylococcal bacteraemia ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Staphylococcal sepsis ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Streptococcal sepsis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Tracheobronchitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Urinary tract infection ^† 1	10/749 (1.34%)	13	8/379 (2.11%)	9
Urinary tract infection staphylococcal ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Urosepsis ^† 1	3/749 (0.40%)	3	0/379 (0.00%)	0
Viral sepsis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Injury, poisoning and procedural complications
Ankle fracture ^† 1	0/749 (0.00%)	0	2/379 (0.53%)	2
Cystitis radiation ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Femoral neck fracture ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Fibula fracture ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Gastrointestinal stoma complication ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Hip fracture ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Jaw fracture ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Lower limb fracture ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Lumbar vertebral fracture ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Postoperative wound complication ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Radiation proctitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Skull fracture ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Spinal compression fracture ^† 1	0/749 (0.00%)	0	2/379 (0.53%)	2
Subdural haematoma ^† 1	2/749 (0.27%)	2	1/379 (0.26%)	1
Subdural haemorrhage ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Investigations
Blood creatinine increased ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Computerised tomogram abnormal ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Neutrophil count decreased ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Dehydration ^† 1	6/749 (0.80%)	6	4/379 (1.06%)	4
Diabetes mellitus ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Diabetic metabolic decompensation ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Failure to thrive ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Hyperglycaemia ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Hypoglycaemia ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Hyponatraemia ^† 1	4/749 (0.53%)	4	0/379 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Arthritis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Back pain ^† 1	7/749 (0.93%)	7	1/379 (0.26%)	1
Bone pain ^† 1	1/749 (0.13%)	1	2/379 (0.53%)	2
Bursitis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Musculoskeletal pain ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Neck pain ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Osteitis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Osteoarthritis ^† 1	1/749 (0.13%)	1	2/379 (0.53%)	2
Osteonecrosis of jaw ^† 1	5/749 (0.67%)	5	1/379 (0.26%)	1
Pain in extremity ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Pathological fracture ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Periarthritis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Spinal pain ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Anal squamous cell carcinoma ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Basal cell carcinoma ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Cancer pain ^† 1	1/749 (0.13%)	1	3/379 (0.79%)	3
Carcinoid tumour ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Cardiac myxoma ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Chondrosarcoma ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Chronic lymphocytic leukaemia ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Malignant melanoma ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Malignant pleural effusion ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Nervous system disorders
Amnesia ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Brain injury ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Cauda equina syndrome ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Cerebral haemorrhage ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Cerebral infarction ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Cerebral venous thrombosis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Cerebrovascular accident ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Diabetic coma ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Ischaemic cerebral infarction ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Ischaemic stroke ^† 1	3/749 (0.40%)	3	2/379 (0.53%)	3
Loss of consciousness ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Monoparesis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Neuropathy peripheral ^† 1	1/749 (0.13%)	1	2/379 (0.53%)	2
Paraparesis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Paraplegia ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Peripheral motor neuropathy ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Peripheral sensory neuropathy ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Polyneuropathy ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Sciatica ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Seizure ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Spinal cord compression ^† 1	2/749 (0.27%)	2	1/379 (0.26%)	1
Superior sagittal sinus thrombosis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Syncope ^† 1	7/749 (0.93%)	8	3/379 (0.79%)	3
Transient ischaemic attack ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Vertigo CNS origin ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Product Issues
Device occlusion ^† 1	1/749 (0.13%)	2	0/379 (0.00%)	0
Psychiatric disorders
Mental status changes ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Nightmare ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	5/749 (0.67%)	5	4/379 (1.06%)	4
Calculus bladder ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Haematuria ^† 1	6/749 (0.80%)	8	0/379 (0.00%)	0
Hydronephrosis ^† 1	6/749 (0.80%)	6	2/379 (0.53%)	2
Chronic kidney disease ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Renal atrophy ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Renal failure ^† 1	3/749 (0.40%)	3	1/379 (0.26%)	1
Renal impairment ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Ureterolithiasis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Urinary retention ^† 1	7/749 (0.93%)	8	4/379 (1.06%)	5
Urinary tract obstruction ^† 1	1/749 (0.13%)	1	1/379 (0.26%)	1
Reproductive system and breast disorders
Pelvic pain ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Scrotal oedema ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Acute respiratory failure ^† 1	4/749 (0.53%)	4	2/379 (0.53%)	2
Dyspnoea ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Dyspnoea exertional ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Hydrothorax ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Hypoxia ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Interstitial lung disease ^† 1	2/749 (0.27%)	3	3/379 (0.79%)	3
Pleural effusion ^† 1	3/749 (0.40%)	3	0/379 (0.00%)	0
Pneumonia aspiration ^† 1	2/749 (0.27%)	2	2/379 (0.53%)	2
Pneumonitis ^† 1	3/749 (0.40%)	3	1/379 (0.26%)	1
Pulmonary embolism ^† 1	18/749 (2.40%)	18	15/379 (3.96%)	15
Pulmonary fibrosis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Pulmonary oedema ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Respiratory failure ^† 1	4/749 (0.53%)	4	0/379 (0.00%)	0
Skin and subcutaneous tissue disorders
Rash erythematous ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Vascular disorders
Aortic stenosis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Deep vein thrombosis ^† 1	4/749 (0.53%)	5	1/379 (0.26%)	1
Hypertension ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Hypotension ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Hypovolaemic shock ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Shock ^† 1	2/749 (0.27%)	2	0/379 (0.00%)	0
Temporal arteritis ^† 1	1/749 (0.13%)	1	0/379 (0.00%)	0
Thrombophlebitis ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
Venous thrombosis limb ^† 1	0/749 (0.00%)	0	1/379 (0.26%)	1
1 Term from vocabulary, MedDRA 22.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	DCVAC/PCa With Standard of Care Chemotherapy		Placebo With Standard of Care Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	670/749 (89.45%)		365/379 (96.31%)
Blood and lymphatic system disorders
Anaemia ^† 1	123/749 (16.42%)	159	76/379 (20.05%)	96
Leukopenia ^† 1	63/749 (8.41%)	103	33/379 (8.71%)	74
Neutropenia ^† 1	103/749 (13.75%)	177	54/379 (14.25%)	92
Eye disorders
Lacrimation increased ^† 1	29/749 (3.87%)	29	30/379 (7.92%)	32
Gastrointestinal disorders
Abdominal pain ^† 1	28/749 (3.74%)	31	23/379 (6.07%)	26
Constipation ^† 1	111/749 (14.82%)	133	71/379 (18.73%)	94
Diarrhoea ^† 1	204/749 (27.24%)	338	115/379 (30.34%)	183
Dyspepsia ^† 1	44/749 (5.87%)	47	22/379 (5.80%)	26
Nausea ^† 1	150/749 (20.03%)	196	96/379 (25.33%)	142
Stomatitis ^† 1	39/749 (5.21%)	54	24/379 (6.33%)	35
Vomiting ^† 1	78/749 (10.41%)	97	43/379 (11.35%)	53
General disorders
Asthenia ^† 1	106/749 (14.15%)	156	69/379 (18.21%)	107
Fatigue ^† 1	268/749 (35.78%)	374	152/379 (40.11%)	219
Mucosal inflammation ^† 1	28/749 (3.74%)	33	22/379 (5.80%)	37
Oedema peripheral ^† 1	121/749 (16.15%)	146	87/379 (22.96%)	107
Pyrexia ^† 1	76/749 (10.15%)	104	42/379 (11.08%)	64
Infections and infestations
Nasopharyngitis ^† 1	33/749 (4.41%)	39	22/379 (5.80%)	26
Upper respiratory tract infection ^† 1	34/749 (4.54%)	41	20/379 (5.28%)	23
Urinary tract infection ^† 1	53/749 (7.08%)	76	39/379 (10.29%)	66
Investigations
Weight decreased ^† 1	46/749 (6.14%)	48	24/379 (6.33%)	25
Metabolism and nutrition disorders
Decreased appetite ^† 1	110/749 (14.69%)	137	79/379 (20.84%)	102
Hyperglycaemia ^† 1	56/749 (7.48%)	81	27/379 (7.12%)	41
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	114/749 (15.22%)	153	74/379 (19.53%)	110
Back pain ^† 1	113/749 (15.09%)	135	67/379 (17.68%)	79
Bone pain ^† 1	78/749 (10.41%)	91	26/379 (6.86%)	29
Muscular weakness ^† 1	32/749 (4.27%)	36	23/379 (6.07%)	26
Musculoskeletal pain ^† 1	46/749 (6.14%)	51	24/379 (6.33%)	28
Myalgia ^† 1	53/749 (7.08%)	74	32/379 (8.44%)	47
Pain in extremity ^† 1	87/749 (11.62%)	104	55/379 (14.51%)	74
Nervous system disorders
Dizziness ^† 1	41/749 (5.47%)	47	33/379 (8.71%)	40
Dysgeusia ^† 1	80/749 (10.68%)	105	59/379 (15.57%)	91
Headache ^† 1	35/749 (4.67%)	38	27/379 (7.12%)	33
Hypoaesthesia ^† 1	32/749 (4.27%)	41	20/379 (5.28%)	25
Neuropathy peripheral ^† 1	83/749 (11.08%)	110	54/379 (14.25%)	59
Paraesthesia ^† 1	76/749 (10.15%)	95	33/379 (8.71%)	42
Peripheral sensory neuropathy ^† 1	36/749 (4.81%)	39	28/379 (7.39%)	31
Polyneuropathy ^† 1	44/749 (5.87%)	47	24/379 (6.33%)	28
Taste disorder ^† 1	37/749 (4.94%)	39	21/379 (5.54%)	23
Psychiatric disorders
Insomnia ^† 1	32/749 (4.27%)	33	24/379 (6.33%)	25
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	82/749 (10.95%)	95	47/379 (12.40%)	54
Dyspnoea ^† 1	82/749 (10.95%)	103	55/379 (14.51%)	65
Skin and subcutaneous tissue disorders
Alopecia ^† 1	222/749 (29.64%)	224	130/379 (34.30%)	131
Nail disorder ^† 1	38/749 (5.07%)	41	28/379 (7.39%)	28
Rash ^† 1	36/749 (4.81%)	40	22/379 (5.80%)	25
Vascular disorders
Hypertension ^† 1	43/749 (5.74%)	56	34/379 (8.97%)	44
Hypotension ^† 1	40/749 (5.34%)	48	28/379 (7.39%)	39
1 Term from vocabulary, MedDRA 22.1 † Indicates events were collected by 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.

Any formal publication of clinical trial results will be a collaborative effort between the sponsor and the investigator(s). All manuscripts or abstracts will be reviewed and approved in written by the sponsor before submission. The sponsor may request a delay in publication if there are important intellectual property concerns but does not have the right to suppress the publication of the clinical trial results indefinitely.

Results Point of Contact

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Name/Title:	Prof. Radek Spisek, M.D., Ph.D.
Organization:	SOTIO a.s.
Phone:	+420 2241 75101
EMail:	spisek@sotio.com

Layout table for additonal information

Responsible Party:	Sotio a.s.
ClinicalTrials.gov Identifier:	NCT02111577
Other Study ID Numbers:	SP005 2012-002814-38 ( EudraCT Number )
First Submitted:	April 9, 2014
First Posted:	April 11, 2014
Results First Submitted:	January 22, 2021
Results First Posted:	April 6, 2021
Last Update Posted:	April 6, 2021

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