Trial Outcomes & Findings for Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer (NCT NCT03686683)

Last Updated: 2024-10-08

Results Overview

Percentage of participants without histological reclassification (Gleason group upgrade) within 36 months of randomization as determined by Blinded Independent Central Review (BICR) o Upgrade is defined as participants at randomization with either International Society of Urological Pathology (ISUP) Grade Group 1 (Gleason 3+3) upgraded to Grade Group 2 (Gleason 3+4) or higher or participants at randomization with Grade Group 2 upgraded to Grade Group 3 (Gleason 4+3) or higher.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

532 participants

Primary outcome timeframe

Once all participants have completed at least 3 years following randomization

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group: Sipuleucel-T Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).	Control Arm: Active Surveillance Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.
Overall Study STARTED	356	176
Overall Study COMPLETED	262	118
Overall Study NOT COMPLETED	94	58

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group: Sipuleucel-T Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).	Control Arm: Active Surveillance Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.
Overall Study Withdrawal by Subject	52	32
Overall Study Lost to Follow-up	23	19
Overall Study Adverse Event	1	0
Overall Study Death	10	5
Overall Study Progressive Disease	1	1
Overall Study Noncompliance	1	0
Overall Study Physician Decision	1	1
Overall Study Screen fail post-randomization	1	0
Overall Study Protocol Violation	3	0
Overall Study No data available	1	0

Baseline Characteristics

3 participants did not report a baseline value for Height

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group: Sipuleucel-T n=356 Participants Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).	Control Arm: Active Surveillance n=176 Participants Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.	Total n=532 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=356 Participants	0 Participants n=176 Participants	0 Participants n=532 Participants
Age, Categorical Between 18 and 65 years	183 Participants n=356 Participants	92 Participants n=176 Participants	275 Participants n=532 Participants
Age, Categorical >=65 years	173 Participants n=356 Participants	84 Participants n=176 Participants	257 Participants n=532 Participants
Age, Continuous	64.1 years STANDARD_DEVIATION 7.27 • n=356 Participants	63.9 years STANDARD_DEVIATION 7.72 • n=176 Participants	64.0 years STANDARD_DEVIATION 7.41 • n=532 Participants
Sex: Female, Male Female	0 Participants n=356 Participants	0 Participants n=176 Participants	0 Participants n=532 Participants
Sex: Female, Male Male	356 Participants n=356 Participants	176 Participants n=176 Participants	532 Participants n=532 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=356 Participants	0 Participants n=176 Participants	4 Participants n=532 Participants
Race (NIH/OMB) Asian	3 Participants n=356 Participants	0 Participants n=176 Participants	3 Participants n=532 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=356 Participants	0 Participants n=176 Participants	0 Participants n=532 Participants
Race (NIH/OMB) Black or African American	38 Participants n=356 Participants	21 Participants n=176 Participants	59 Participants n=532 Participants
Race (NIH/OMB) White	309 Participants n=356 Participants	152 Participants n=176 Participants	461 Participants n=532 Participants
Race (NIH/OMB) More than one race	NA Participants n=356 Participants	NA Participants n=176 Participants	NA Participants n=532 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=356 Participants	3 Participants n=176 Participants	5 Participants n=532 Participants
Height	177.4 centimeters STANDARD_DEVIATION 6.7 • n=353 Participants • 3 participants did not report a baseline value for Height	178.1 centimeters STANDARD_DEVIATION 7.7 • n=176 Participants • 3 participants did not report a baseline value for Height	177.6 centimeters STANDARD_DEVIATION 7.1 • n=529 Participants • 3 participants did not report a baseline value for Height
Weight	91.6 kilograms STANDARD_DEVIATION 16.7 • n=353 Participants • 3 participants did not report a baseline value for Weight	91.7 kilograms STANDARD_DEVIATION 20.0 • n=176 Participants • 3 participants did not report a baseline value for Weight	91.7 kilograms STANDARD_DEVIATION 17.9 • n=529 Participants • 3 participants did not report a baseline value for Weight
Body Mass Index	29.1 kg/m^2 STANDARD_DEVIATION 5.0 • n=353 Participants • 3 participants did not report a baseline value for Weight in order to calculate the BMI	28.8 kg/m^2 STANDARD_DEVIATION 5.4 • n=176 Participants • 3 participants did not report a baseline value for Weight in order to calculate the BMI	29.0 kg/m^2 STANDARD_DEVIATION 5.1 • n=529 Participants • 3 participants did not report a baseline value for Weight in order to calculate the BMI

PRIMARY outcome

Timeframe: Once all participants have completed at least 3 years following randomization

Outcome measures

Outcome measures
Measure	Treatment Group: Sipuleucel-T n=356 Participants Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).	Control Arm: Active Surveillance n=176 Participants Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.
Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade).	108 Participants	48 Participants

Adverse Events

Treatment Group: Sipuleucel-T

Serious events: 74 serious events

Other events: 321 other events

Deaths: 10 deaths

Control Arm: Active Surveillance

Serious events: 22 serious events

Other events: 133 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Clinical Operations

Dendreon Corporation

Phone: 206-455-2476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the Study may be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Treatment Group: Sipuleucel-T n=345 participants at risk Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).	Control Arm: Active Surveillance n=176 participants at risk Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.
Renal and urinary disorders Haematuria	1.2% 4/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 4/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Coronary artery disease	0.87% 3/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Atrial fibrillation	0.87% 3/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Cardiac failure congestive	0.58% 2/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Angina pectoris	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Sepsis	0.87% 3/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Cellulitis	0.87% 3/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Peritonsillar abscess	0.58% 2/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.58% 2/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.58% 2/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Nervous system disorders Syncope	0.00% 0/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Vascular disorders Aortic dissection	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Vascular disorders Deep vein thrombosis	0.58% 2/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.58% 2/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.58% 2/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Gastrointestinal disorders Rectal haemorrhage	0.58% 2/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.87% 3/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Musculoskeletal and connective tissue disorders Flank pain	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Renal and urinary disorders Acute kidney injury	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Hepatobiliary disorders Cholelithiasis	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Acute myocardial infarction	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Angina unstable	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Arteriosclerosis coronary artery	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Cardiac arrest	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Cardiac tamponade	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Coronary artery stenosis	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Coronary ostial stenosis	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Pericarditis	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Sinus node dysfunction	0.00% 0/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Cardiac disorders Tachycardia	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Pneumonia	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations COVID-19	0.00% 0/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Cat scratch disease	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Diverticulitis	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Endocarditis	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Escherichia bacteraemia	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Influenza	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Klebsiella bacteraemia	0.00% 0/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Osteomyelitis	0.29% 1/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.

Other adverse events
Measure	Treatment Group: Sipuleucel-T n=345 participants at risk Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).	Control Arm: Active Surveillance n=176 participants at risk Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.
General disorders Chills	20.3% 70/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	1.1% 2/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
General disorders Fatigue	17.7% 61/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	3.4% 6/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Reproductive system and breast disorders Erectile dysfunction	11.3% 39/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	10.8% 19/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Nervous system disorders Headache	11.0% 38/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	1.7% 3/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Nervous system disorders Paraesthesia	11.0% 38/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
General disorders Pyrexia	11.0% 38/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.57% 1/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Musculoskeletal and connective tissue disorders Arthralgia	9.9% 34/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	4.5% 8/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Gastrointestinal disorders Nausea	8.7% 30/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	2.3% 4/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations COVID-19	8.4% 29/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	5.1% 9/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
General disorders Influenza like illness	7.2% 25/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	1.1% 2/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Renal and urinary disorders Haematuria	6.4% 22/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	5.7% 10/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Nervous system disorders Paraesthesia oral	6.1% 21/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Gastrointestinal disorders Diarrhoea	5.8% 20/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	4.0% 7/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Nervous system disorders Dizziness	5.8% 20/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	3.4% 6/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Vascular disorders Hypertension	5.8% 20/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	5.1% 9/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Renal and urinary disorders Nocturia	5.8% 20/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	6.8% 12/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
General disorders Pain	5.8% 20/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	0.00% 0/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Renal and urinary disorders Pollakiuria	5.8% 20/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	5.1% 9/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Gastrointestinal disorders Rectal examination abnormal	5.8% 20/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	3.4% 6/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Nasopharyngitis	5.2% 18/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	1.1% 2/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Infections and infestations Urinary tract infection	3.8% 13/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	5.7% 10/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.
Reproductive system and breast disorders Prostatitis	1.7% 6/345 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.	5.1% 9/176 • 4 years, 5 months All participants who received at least 1 infusion of sipuleucel-T (N=345) or after randomization in the control arm (N=176) were followed for safety. Total no. affected (74 in sipuleucel-T arm and 22 in Control arm) = the number of participants who experienced at least one serious adverse event (SAE). Participants may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Participants with \<1 occurrence of the same event are counted only once.