Trial Outcomes & Findings for Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (NCT NCT02111577)

NCT ID: NCT02111577

Last Updated: 2021-04-06

Results Overview

Overall survival is defined as the time from randomization until death due to any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1182 participants

Primary outcome timeframe

From randomization to death due to any cause, up to 58 months

Results posted on

2021-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	DCVAC/PCa With Standard of Care Chemotherapy Combination therapy with dendritic cell vaccine for prostate cancer (DCVAC/PCa) and standard of care chemotherapy (docetaxel and prednisone)	Placebo With Standard of Care Chemotherapy Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Study STARTED	787	395
Overall Study COMPLETED	188	106
Overall Study NOT COMPLETED	599	289

Reasons for withdrawal

Reasons for withdrawal
Measure	DCVAC/PCa With Standard of Care Chemotherapy Combination therapy with dendritic cell vaccine for prostate cancer (DCVAC/PCa) and standard of care chemotherapy (docetaxel and prednisone)	Placebo With Standard of Care Chemotherapy Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Study Protocol Violation	2	0
Overall Study Unable to tolerate leukapheresis	1	0
Overall Study Failure to produce study treatment	6	0
Overall Study Death	518	254
Overall Study Medical monitor's decision (active hepatitis B)	1	0
Overall Study Adverse Event	1	1
Overall Study Withdrawal by Subject	51	23
Overall Study Disease progression	0	1
Overall Study Lost to Follow-up	19	10

Baseline Characteristics

PSA available for 786 patients in the experimental arm (DCVAC/PCa) and 394 patients in the control arm (placebo)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=787 Participants Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Placebo With Standard of Care Chemotherapy n=395 Participants Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator	Total n=1182 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=787 Participants	0 Participants n=395 Participants	0 Participants n=1182 Participants
Age, Categorical Between 18 and 65 years	272 Participants n=787 Participants	107 Participants n=395 Participants	379 Participants n=1182 Participants
Age, Categorical >=65 years	515 Participants n=787 Participants	288 Participants n=395 Participants	803 Participants n=1182 Participants
Age, Continuous	68.0 years n=787 Participants	69.0 years n=395 Participants	68.0 years n=1182 Participants
Sex: Female, Male Female	0 Participants n=787 Participants	0 Participants n=395 Participants	0 Participants n=1182 Participants
Sex: Female, Male Male	787 Participants n=787 Participants	395 Participants n=395 Participants	1182 Participants n=1182 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=787 Participants	0 Participants n=395 Participants	0 Participants n=1182 Participants
Race (NIH/OMB) Asian	5 Participants n=787 Participants	4 Participants n=395 Participants	9 Participants n=1182 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=787 Participants	0 Participants n=395 Participants	1 Participants n=1182 Participants
Race (NIH/OMB) Black or African American	26 Participants n=787 Participants	19 Participants n=395 Participants	45 Participants n=1182 Participants
Race (NIH/OMB) White	733 Participants n=787 Participants	358 Participants n=395 Participants	1091 Participants n=1182 Participants
Race (NIH/OMB) More than one race	4 Participants n=787 Participants	3 Participants n=395 Participants	7 Participants n=1182 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=787 Participants	11 Participants n=395 Participants	29 Participants n=1182 Participants
Region of Enrollment Hungary	28 participants n=787 Participants	14 participants n=395 Participants	42 participants n=1182 Participants
Region of Enrollment United States	144 participants n=787 Participants	73 participants n=395 Participants	217 participants n=1182 Participants
Region of Enrollment Czechia	102 participants n=787 Participants	40 participants n=395 Participants	142 participants n=1182 Participants
Region of Enrollment United Kingdom	60 participants n=787 Participants	36 participants n=395 Participants	96 participants n=1182 Participants
Region of Enrollment Belarus	13 participants n=787 Participants	18 participants n=395 Participants	31 participants n=1182 Participants
Region of Enrollment Portugal	20 participants n=787 Participants	10 participants n=395 Participants	30 participants n=1182 Participants
Region of Enrollment Spain	18 participants n=787 Participants	14 participants n=395 Participants	32 participants n=1182 Participants
Region of Enrollment Austria	14 participants n=787 Participants	5 participants n=395 Participants	19 participants n=1182 Participants
Region of Enrollment Latvia	0 participants n=787 Participants	2 participants n=395 Participants	2 participants n=1182 Participants
Region of Enrollment Netherlands	29 participants n=787 Participants	19 participants n=395 Participants	48 participants n=1182 Participants
Region of Enrollment Sweden	4 participants n=787 Participants	1 participants n=395 Participants	5 participants n=1182 Participants
Region of Enrollment Belgium	20 participants n=787 Participants	11 participants n=395 Participants	31 participants n=1182 Participants
Region of Enrollment Denmark	2 participants n=787 Participants	0 participants n=395 Participants	2 participants n=1182 Participants
Region of Enrollment Poland	94 participants n=787 Participants	36 participants n=395 Participants	130 participants n=1182 Participants
Region of Enrollment Italy	19 participants n=787 Participants	3 participants n=395 Participants	22 participants n=1182 Participants
Region of Enrollment Slovakia	49 participants n=787 Participants	15 participants n=395 Participants	64 participants n=1182 Participants
Region of Enrollment Bulgaria	15 participants n=787 Participants	10 participants n=395 Participants	25 participants n=1182 Participants
Region of Enrollment France	18 participants n=787 Participants	12 participants n=395 Participants	30 participants n=1182 Participants
Region of Enrollment Lithuania	6 participants n=787 Participants	5 participants n=395 Participants	11 participants n=1182 Participants
Region of Enrollment Serbia	22 participants n=787 Participants	14 participants n=395 Participants	36 participants n=1182 Participants
Region of Enrollment Germany	92 participants n=787 Participants	51 participants n=395 Participants	143 participants n=1182 Participants
Region of Enrollment Croatia	18 participants n=787 Participants	6 participants n=395 Participants	24 participants n=1182 Participants
Prostate-specific antigen	46.35 ng/L n=786 Participants • PSA available for 786 patients in the experimental arm (DCVAC/PCa) and 394 patients in the control arm (placebo)	54.02 ng/L n=394 Participants • PSA available for 786 patients in the experimental arm (DCVAC/PCa) and 394 patients in the control arm (placebo)	47.87 ng/L n=1180 Participants • PSA available for 786 patients in the experimental arm (DCVAC/PCa) and 394 patients in the control arm (placebo)

PRIMARY outcome

Timeframe: From randomization to death due to any cause, up to 58 months

Population: Intention-to-treat population definition: All randomized patients

Overall survival is defined as the time from randomization until death due to any cause.

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=787 Participants 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.	Placebo With Standard of Care Chemotherapy n=395 Participants 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 Survival, Intention-to-treat Population	23.9 Months Interval 21.6 to 25.3	24.3 Months Interval 22.6 to 26.0

SECONDARY outcome

Timeframe: From randomization to death due to any cause, up to 58 months

Population: 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

Overall survival is defined as the time from randomization until death due to any cause.

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=438 Participants 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.	Placebo With Standard of Care Chemotherapy n=284 Participants 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 Survival, Per Protocol Population	29.7 Months Interval 26.9 to 32.3	26.7 Months Interval 24.7 to 28.8

SECONDARY outcome

Timeframe: From randomization to death due to any cause, up to 58 months

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

Overall survival is defined as the time from randomization until death due to any cause.

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=187 Participants 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.	Placebo With Standard of Care Chemotherapy n=103 Participants 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 Survival, Intention-to-treat Population, Abiraterone as Prior Therapy	16.6 Months Interval 14.9 to 19.7	21.0 Months Interval 16.6 to 24.1

SECONDARY outcome

Timeframe: From randomization to death due to any cause, up to 58 months

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

Overall survival is defined as the time from randomization until death due to any cause.

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=137 Participants 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.	Placebo With Standard of Care Chemotherapy n=60 Participants 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 Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy	15.2 Months Interval 13.3 to 18.3	21.4 Months Interval 15.1 to 26.5

SECONDARY outcome

Timeframe: From randomization to death due to any cause, up to 58 months

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

Overall survival is defined as the time from randomization until death due to any cause.

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=546 Participants 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.	Placebo With Standard of Care Chemotherapy n=271 Participants 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 Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide	26.7 Months Interval 25.2 to 28.8	25.7 Months Interval 23.8 to 28.3

SECONDARY outcome

Timeframe: 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

Population: Intention-to-treat population definition: All randomized patients

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.

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=787 Participants 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.	Placebo With Standard of Care Chemotherapy n=395 Participants 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.
Radiological Progression-free Survival, Intention-to-treat Population	11.1 Months Interval 11.0 to 11.4	11.1 Months Interval 10.8 to 11.4

SECONDARY outcome

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=438 Participants 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.	Placebo With Standard of Care Chemotherapy n=284 Participants 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.
Radiological Progression-free Survival, Per Protocol Population	11.2 Months Interval 11.1 to 11.7	11.2 Months Interval 11.0 to 11.8

SECONDARY outcome

Timeframe: 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

Population: Intention-to-treat population definition: All randomized patients

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.

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=787 Participants 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.	Placebo With Standard of Care Chemotherapy n=395 Participants 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.
Time to PSA Progression, Intention-to-treat Population	10.5 Months Interval 9.7 to 10.6	10.6 Months Interval 10.4 to 10.7

SECONDARY outcome

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=438 Participants 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.	Placebo With Standard of Care Chemotherapy n=284 Participants 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.
Time to PSA Progression, Per Protocol Population	10.5 Months Interval 10.4 to 10.7	10.6 Months Interval 10.4 to 10.7

SECONDARY outcome

Timeframe: Time from randomization to the date of the first skeletal-related event, up to 58 months

Population: Intention-to-treat population definition: All randomized patients

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

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=787 Participants 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.	Placebo With Standard of Care Chemotherapy n=395 Participants 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.
Time to First Skeletal-related Event, Intention-to-treat Population	NA Months Not reached; insufficient number of participants with events	NA Months Not reached; insufficient number of participants with events

SECONDARY outcome

Timeframe: Time from randomization to the date of the first skeletal-related event, up to 58 months

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

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=438 Participants 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.	Placebo With Standard of Care Chemotherapy n=284 Participants 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.
Time to First Skeletal-related Event, Per Protocol Population	NA Months Not reached; insufficient number of participants with events	NA Months Not reached; insufficient number of participants with events

SECONDARY outcome

Timeframe: Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months

Population: Intention-to-treat population definition: All randomized patients

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

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=787 Participants 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.	Placebo With Standard of Care Chemotherapy n=395 Participants 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.
Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population	11.1 Months Interval 10.9 to 11.3	10.9 Months Interval 10.5 to 11.2

SECONDARY outcome

Timeframe: Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months

Population: 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

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=438 Participants 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.	Placebo With Standard of Care Chemotherapy n=284 Participants 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.
Time to Radiological Progression or Skeletal-related Event, Per Protocol Population	11.1 Months Interval 11.0 to 11.5	11.1 Months Interval 10.8 to 11.3

SECONDARY outcome

Timeframe: From randomization to the end of the study, up to 57 months

Population: Intention-to-treat population definition: All randomized patients

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=787 Participants 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.	Placebo With Standard of Care Chemotherapy n=395 Participants 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.
Proportion of Patients With Skeletal-related Events, Intention-to-treat Population	43 Patients	26 Patients

SECONDARY outcome

Timeframe: From randomization to the end of the study, up to 57 months

Outcome measures

Outcome measures
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=438 Participants 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.	Placebo With Standard of Care Chemotherapy n=284 Participants 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.
Proportion of Patients With Skeletal-related Events, Per Protocol Population	28 Patients	20 Patients

Adverse Events

DCVAC/PCa With Standard of Care Chemotherapy

Serious events: 237 serious events

Other events: 670 other events

Deaths: 518 deaths

Placebo With Standard of Care Chemotherapy

Serious events: 150 serious events

Other events: 365 other events

Deaths: 254 deaths

Serious adverse events

Other adverse events

Additional Information

Prof. Radek Spisek, M.D., Ph.D.

SOTIO a.s.

Phone: +420 2241 75101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=749 participants at risk Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Placebo With Standard of Care Chemotherapy n=379 participants at risk Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Vascular disorders Aortic stenosis	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Vascular disorders Deep vein thrombosis	0.53% 4/749 • Number of events 5 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
Vascular disorders Hypertension	0.00% 0/749 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
Vascular disorders Hypotension	0.27% 2/749 • Number of events 2 • 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. 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.	0.00% 0/379 • 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. 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.
Vascular disorders Hypovolaemic shock	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Vascular disorders Shock	0.27% 2/749 • Number of events 2 • 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. 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.	0.00% 0/379 • 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. 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.
Vascular disorders Temporal arteritis	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Vascular disorders Thrombophlebitis	0.00% 0/749 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
Vascular disorders Venous thrombosis limb	0.00% 0/749 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal squamous cell carcinoma	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.27% 2/749 • Number of events 2 • 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. 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.	0.00% 0/379 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.13% 1/749 • Number of events 1 • 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. 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.	0.79% 3/379 • Number of events 3 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac myxoma	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.00% 0/749 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.13% 1/749 • Number of events 1 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Immune system disorders Allergy to arthropod sting	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Immune system disorders Anaphylactic reaction	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Immune system disorders Hypersensitivity	0.00% 0/749 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
General disorders Asthenia	0.40% 3/749 • Number of events 3 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
General disorders Catheter site inflammation	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
General disorders Complication associated with device	0.00% 0/749 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
General disorders Death	0.67% 5/749 • Number of events 5 • 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. 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.	1.3% 5/379 • Number of events 5 • 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. 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.
General disorders Fatigue	0.67% 5/749 • Number of events 5 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
General disorders General physical health deterioration	0.80% 6/749 • Number of events 6 • 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. 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.	0.00% 0/379 • 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. 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.
General disorders Chest pain	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
General disorders Non-cardiac chest pain	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
General disorders Oedema peripheral	0.13% 1/749 • Number of events 1 • 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. 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.	0.26% 1/379 • Number of events 1 • 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. 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.
General disorders Pyrexia	1.2% 9/749 • Number of events 13 • 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. 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.	1.6% 6/379 • Number of events 9 • 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. 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.
General disorders Sudden death	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
General disorders Systemic inflammatory response syndrome	0.00% 0/749 • 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. 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.	0.79% 3/379 • Number of events 4 • 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. 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.
Psychiatric disorders Mental status changes	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Psychiatric disorders Nightmare	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Reproductive system and breast disorders Pelvic pain	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Reproductive system and breast disorders Scrotal oedema	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/749 • 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. 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.	0.53% 2/379 • Number of events 2 • 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. 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.
Injury, poisoning and procedural complications Cystitis radiation	0.13% 1/749 • Number of events 1 • 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. 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.	0.00% 0/379 • 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. 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.

Other adverse events
Measure	DCVAC/PCa With Standard of Care Chemotherapy n=749 participants at risk Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	Placebo With Standard of Care Chemotherapy n=379 participants at risk Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Vascular disorders Hypertension	5.7% 43/749 • Number of events 56 • 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. 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.	9.0% 34/379 • Number of events 44 • 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. 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.
Vascular disorders Hypotension	5.3% 40/749 • Number of events 48 • 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. 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.	7.4% 28/379 • Number of events 39 • 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. 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.
General disorders Asthenia	14.2% 106/749 • Number of events 156 • 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. 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.	18.2% 69/379 • Number of events 107 • 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. 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.
General disorders Fatigue	35.8% 268/749 • Number of events 374 • 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. 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.	40.1% 152/379 • Number of events 219 • 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. 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.
General disorders Mucosal inflammation	3.7% 28/749 • Number of events 33 • 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. 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.	5.8% 22/379 • Number of events 37 • 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. 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.
General disorders Oedema peripheral	16.2% 121/749 • Number of events 146 • 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. 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.	23.0% 87/379 • Number of events 107 • 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. 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.
General disorders Pyrexia	10.1% 76/749 • Number of events 104 • 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. 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.	11.1% 42/379 • Number of events 64 • 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. 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.
Psychiatric disorders Insomnia	4.3% 32/749 • Number of events 33 • 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. 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.	6.3% 24/379 • Number of events 25 • 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. 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.
Investigations Weight decreased	6.1% 46/749 • Number of events 48 • 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. 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.	6.3% 24/379 • Number of events 25 • 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. 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.
Blood and lymphatic system disorders Anaemia	16.4% 123/749 • Number of events 159 • 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. 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.	20.1% 76/379 • Number of events 96 • 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. 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.
Blood and lymphatic system disorders Leukopenia	8.4% 63/749 • Number of events 103 • 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. 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.	8.7% 33/379 • Number of events 74 • 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. 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.
Blood and lymphatic system disorders Neutropenia	13.8% 103/749 • Number of events 177 • 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. 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.	14.2% 54/379 • Number of events 92 • 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. 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.
Respiratory, thoracic and mediastinal disorders Cough	10.9% 82/749 • Number of events 95 • 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. 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.	12.4% 47/379 • Number of events 54 • 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. 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.9% 82/749 • Number of events 103 • 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. 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.	14.5% 55/379 • Number of events 65 • 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. 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.
Nervous system disorders Dizziness	5.5% 41/749 • Number of events 47 • 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. 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.	8.7% 33/379 • Number of events 40 • 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. 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.
Nervous system disorders Dysgeusia	10.7% 80/749 • Number of events 105 • 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. 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.	15.6% 59/379 • Number of events 91 • 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. 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.
Nervous system disorders Headache	4.7% 35/749 • Number of events 38 • 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. 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.	7.1% 27/379 • Number of events 33 • 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. 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.
Nervous system disorders Hypoaesthesia	4.3% 32/749 • Number of events 41 • 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. 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.	5.3% 20/379 • Number of events 25 • 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. 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.
Nervous system disorders Neuropathy peripheral	11.1% 83/749 • Number of events 110 • 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. 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.	14.2% 54/379 • Number of events 59 • 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. 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.
Nervous system disorders Paraesthesia	10.1% 76/749 • Number of events 95 • 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. 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.	8.7% 33/379 • Number of events 42 • 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. 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.
Nervous system disorders Peripheral sensory neuropathy	4.8% 36/749 • Number of events 39 • 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. 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.	7.4% 28/379 • Number of events 31 • 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. 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.
Nervous system disorders Polyneuropathy	5.9% 44/749 • Number of events 47 • 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. 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.	6.3% 24/379 • Number of events 28 • 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. 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.
Nervous system disorders Taste disorder	4.9% 37/749 • Number of events 39 • 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. 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.	5.5% 21/379 • Number of events 23 • 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. 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.
Eye disorders Lacrimation increased	3.9% 29/749 • Number of events 29 • 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. 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.	7.9% 30/379 • Number of events 32 • 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. 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.
Gastrointestinal disorders Abdominal pain	3.7% 28/749 • Number of events 31 • 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. 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.	6.1% 23/379 • Number of events 26 • 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. 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.
Gastrointestinal disorders Constipation	14.8% 111/749 • Number of events 133 • 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. 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.	18.7% 71/379 • Number of events 94 • 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. 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.
Gastrointestinal disorders Diarrhoea	27.2% 204/749 • Number of events 338 • 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. 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.	30.3% 115/379 • Number of events 183 • 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. 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.
Gastrointestinal disorders Dyspepsia	5.9% 44/749 • Number of events 47 • 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. 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.	5.8% 22/379 • Number of events 26 • 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. 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.
Gastrointestinal disorders Nausea	20.0% 150/749 • Number of events 196 • 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. 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.	25.3% 96/379 • Number of events 142 • 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. 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.
Gastrointestinal disorders Stomatitis	5.2% 39/749 • Number of events 54 • 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. 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.	6.3% 24/379 • Number of events 35 • 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. 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.
Gastrointestinal disorders Vomiting	10.4% 78/749 • Number of events 97 • 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. 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.	11.3% 43/379 • Number of events 53 • 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. 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.
Skin and subcutaneous tissue disorders Alopecia	29.6% 222/749 • Number of events 224 • 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. 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.	34.3% 130/379 • Number of events 131 • 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. 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.
Skin and subcutaneous tissue disorders Nail disorder	5.1% 38/749 • Number of events 41 • 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. 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.	7.4% 28/379 • Number of events 28 • 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. 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.
Skin and subcutaneous tissue disorders Rash	4.8% 36/749 • Number of events 40 • 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. 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.	5.8% 22/379 • Number of events 25 • 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. 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.
Musculoskeletal and connective tissue disorders Arthralgia	15.2% 114/749 • Number of events 153 • 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. 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.	19.5% 74/379 • Number of events 110 • 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. 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.
Musculoskeletal and connective tissue disorders Back pain	15.1% 113/749 • Number of events 135 • 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. 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.	17.7% 67/379 • Number of events 79 • 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. 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.
Musculoskeletal and connective tissue disorders Bone pain	10.4% 78/749 • Number of events 91 • 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. 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.	6.9% 26/379 • Number of events 29 • 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. 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.
Musculoskeletal and connective tissue disorders Muscular weakness	4.3% 32/749 • Number of events 36 • 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. 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.	6.1% 23/379 • Number of events 26 • 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. 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.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.1% 46/749 • Number of events 51 • 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. 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.	6.3% 24/379 • Number of events 28 • 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. 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.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 53/749 • Number of events 74 • 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. 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.	8.4% 32/379 • Number of events 47 • 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. 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.