Trial Outcomes & Findings for PROvenge Treatment and Early Cancer Treatment (NCT NCT00779402)

Last Updated: 2018-01-29

Results Overview

Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

176 participants

Primary outcome timeframe

Every 3 months post-infusion

Results posted on

2018-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Sipuleucel-T Provenge Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF	Control Control Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen
Treatment Phase 1 STARTED	117	59
Treatment Phase 1 Received ≥1 Leukapherisis (Safety Set)	116	59
Treatment Phase 1 Received ≥1 Study Product (Exposure Set)	113	59
Treatment Phase 1 Received Booster Infusion	50	30
Treatment Phase 1 COMPLETED	84	44
Treatment Phase 1 NOT COMPLETED	33	15
Surveillance Phase STARTED	84	44
Surveillance Phase COMPLETED	41	13
Surveillance Phase NOT COMPLETED	43	31
Long-term Follow-up STARTED	41	13
Long-term Follow-up COMPLETED	20	7
Long-term Follow-up NOT COMPLETED	21	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Sipuleucel-T Provenge Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF	Control Control Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen
Treatment Phase 1 Disease Progression	1	0
Treatment Phase 1 Adverse Event	2	0
Treatment Phase 1 Protocol Violation	1	0
Treatment Phase 1 Patient Refused to Continue	17	2
Treatment Phase 1 Lost to Follow-up	0	1
Treatment Phase 1 Death	0	1
Treatment Phase 1 Intercurrent Illness	1	1
Treatment Phase 1 Withdrawal by Subject	1	0
Treatment Phase 1 Other	4	2
Treatment Phase 1 Closure of Study	3	2
Treatment Phase 1 Completed Protocol Visits	3	6
Surveillance Phase Protocol Violation	0	1
Surveillance Phase Patient refused to continue	22	14
Surveillance Phase Lost to Follow-up	2	1
Surveillance Phase Death	0	1
Surveillance Phase Intercurrent Illness	2	0
Surveillance Phase Other	5	5
Surveillance Phase Withdrawal by Subject	4	1
Surveillance Phase Closure of study	5	6
Surveillance Phase Completed Protocol Visits	3	2
Long-term Follow-up Patient refused to continue	2	0
Long-term Follow-up Other	5	0
Long-term Follow-up Closure of Study	8	4
Long-term Follow-up Completed Protocol Visits	6	2

Baseline Characteristics

PROvenge Treatment and Early Cancer Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sipuleucel-T n=117 Participants Provenge Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF	Control n=59 Participants Control Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen	Total n=176 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 7.40 • n=5 Participants	65.2 years STANDARD_DEVIATION 6.75 • n=7 Participants	64.7 years STANDARD_DEVIATION 7.18 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	59 Participants n=7 Participants	176 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	107 Participants n=5 Participants	55 Participants n=7 Participants	162 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	117 Participants n=5 Participants	59 Participants n=7 Participants	176 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0=Fully Active; No restrictions.	109 Participants n=5 Participants	57 Participants n=7 Participants	166 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1= Restricted Strenuous Activity	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG Missing	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Weight	90.45 Kg STANDARD_DEVIATION 15.52 • n=5 Participants	89.70 Kg STANDARD_DEVIATION 13.85 • n=7 Participants	90.21 Kg STANDARD_DEVIATION 14.95 • n=5 Participants
Gleason Score Gleason Score ≤ 6	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Gleason Score Gleason Score =7	69 Participants n=5 Participants	34 Participants n=7 Participants	103 Participants n=5 Participants
Gleason Score Gleason Score ≥ 8	28 Participants n=5 Participants	12 Participants n=7 Participants	40 Participants n=5 Participants
Time from diagnosis to randomization	5.84 years STANDARD_DEVIATION 2.76 • n=5 Participants	6.34 years STANDARD_DEVIATION 2.76 • n=7 Participants	6.01 years STANDARD_DEVIATION 2.76 • n=5 Participants

PRIMARY outcome

Timeframe: Every 3 months post-infusion

Population: Number of subjects that met biochemical failure criteria.

Outcome measures

Outcome measures
Measure	Sipuleucel-T n=85 Participants Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Control n=45 Participants Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions.
Time to Biochemical Failure Cumulative Incidence Percentile 25th Cumulative Incidence Percentile	7.6 Months Interval 6.2 to 9.2	6.8 Months Interval 6.1 to 9.5
Time to Biochemical Failure Cumulative Incidence Percentile 50th Cumulative Incidence Percentile	14.9 Months Interval 9.8 to 16.1	12.4 Months Interval 9.1 to 18.0
Time to Biochemical Failure Cumulative Incidence Percentile 75th Cumulative Incidence Percentile	22.9 Months Interval 18.3 to 28.8	24.6 Months Interval 17.9 to 54.0

PRIMARY outcome

Timeframe: Every 3 months post-infusion

time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.

Outcome measures

Outcome measures
Measure	Sipuleucel-T n=117 Participants Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Control n=59 Participants Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions.
Number of Subjects That Met Biochemical Failure Status	85 Participants	45 Participants

Adverse Events

Sipuleucel-T

Serious events: 31 serious events

Other events: 114 other events

Deaths: 20 deaths

Control

Serious events: 19 serious events

Other events: 57 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Shabnam Vaziri

Dendreon

Phone: 206-455-2323

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Serious adverse events
Measure	Sipuleucel-T n=116 participants at risk Provenge Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF	Control n=59 participants at risk Control Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Blood and lymphatic system disorders EOSINOPHILIA	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders ACUTE CORONARY SYNDROME	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders ANGINA PECTORIS	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders ATRIAL FIBRILLATION	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders CARDIAC FAILURE CHRONIC	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders CORONARY ARTERY DISEASE	1.7% 2/116 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders MYOCARDIAL INFARCTION	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Cardiac disorders SINUS TACHYCARDIA	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Gastrointestinal disorders COLITIS ULCERATIVE	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
General disorders INFUSION RELATED REACTION	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations ARTHRITIS BACTERIAL	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations LUNG ABSCESS	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations PNEUMONIA	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations PSEUDOMONAL SEPSIS	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	1.7% 2/116 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Injury, poisoning and procedural complications SKIN LACERATION	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders BACK PAIN	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	1.7% 2/116 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	1.7% 2/116 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANAPLASTIC THYROID CANCER	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC MYELOMONOCYTIC LEUKAEMIA	1.7% 2/116 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO SPINE	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC NEOPLASM	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	0.00% 0/59 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA OF THE SKIN	0.00% 0/116 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).

Other adverse events
Measure	Sipuleucel-T n=116 participants at risk Provenge Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF	Control n=59 participants at risk Control Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen
Blood and lymphatic system disorders ANAEMIA	4.3% 5/116 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	8.5% 5/59 • Number of events 6 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Blood and lymphatic system disorders LYMPHADENOPATHY	2.6% 3/116 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 7 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Gastrointestinal disorders DIARRHOEA	12.1% 14/116 • Number of events 19 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	22.0% 13/59 • Number of events 15 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Gastrointestinal disorders CONSTIPATION	13.8% 16/116 • Number of events 18 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	8.5% 5/59 • Number of events 6 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Gastrointestinal disorders NAUSEA	12.9% 15/116 • Number of events 17 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	8.5% 5/59 • Number of events 6 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	6.9% 8/116 • Number of events 9 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	13.6% 8/59 • Number of events 10 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Gastrointestinal disorders ABDOMINAL PAIN	6.0% 7/116 • Number of events 7 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
General disorders FATIGUE	55.2% 64/116 • Number of events 99 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	39.0% 23/59 • Number of events 36 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
General disorders CHILLS	44.0% 51/116 • Number of events 114 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	11.9% 7/59 • Number of events 8 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
General disorders PYREXIA	37.9% 44/116 • Number of events 69 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	3.4% 2/59 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
General disorders INFLUENZA LIKE ILLNESS	13.8% 16/116 • Number of events 23 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 4 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
General disorders PAIN	12.9% 15/116 • Number of events 19 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	1.7% 1/59 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
General disorders ASTHENIA	10.3% 12/116 • Number of events 14 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 7 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
General disorders OEDEMA PERIPHERAL	6.0% 7/116 • Number of events 8 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	11.9% 7/59 • Number of events 11 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	15.5% 18/116 • Number of events 25 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	11.9% 7/59 • Number of events 11 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations NASOPHARYNGITIS	11.2% 13/116 • Number of events 15 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	11.9% 7/59 • Number of events 10 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations URINARY TRACT INFECTION	7.8% 9/116 • Number of events 15 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations SINUSITIS	3.4% 4/116 • Number of events 7 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	6.8% 4/59 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations BRONCHITIS	3.4% 4/116 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Infections and infestations HERPES ZOSTER	1.7% 2/116 • Number of events 2 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Injury, poisoning and procedural complications CONTUSION	5.2% 6/116 • Number of events 7 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	11.9% 7/59 • Number of events 10 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Injury, poisoning and procedural complications CITRATE TOXICITY	6.9% 8/116 • Number of events 8 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 6 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Investigations WEIGHT DECREASED	4.3% 5/116 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Investigations ALANINE AMINOTRANSFERASE INCREASED	2.6% 3/116 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	6.8% 4/59 • Number of events 4 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	4.3% 5/116 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	8.5% 5/59 • Number of events 6 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders BACK PAIN	25.0% 29/116 • Number of events 30 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	13.6% 8/59 • Number of events 9 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders ARTHRALGIA	30.2% 35/116 • Number of events 52 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	15.3% 9/59 • Number of events 9 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders MYALGIA	22.4% 26/116 • Number of events 36 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	8.5% 5/59 • Number of events 8 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	7.8% 9/116 • Number of events 9 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	20.3% 12/59 • Number of events 19 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	12.9% 15/116 • Number of events 18 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	8.5% 5/59 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders NECK PAIN	6.9% 8/116 • Number of events 9 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	8.5% 5/59 • Number of events 6 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	6.9% 8/116 • Number of events 8 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	6.8% 4/59 • Number of events 4 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	8.6% 10/116 • Number of events 11 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	8.6% 10/116 • Number of events 10 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	13.6% 8/59 • Number of events 8 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	4.3% 5/116 • Number of events 5 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	6.8% 4/59 • Number of events 6 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders TENDONITIS	2.6% 3/116 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.86% 1/116 • Number of events 1 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 3 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	5.2% 6/116 • Number of events 9 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	5.1% 3/59 • Number of events 4 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Nervous system disorders PARAESTHESIA ORAL	22.4% 26/116 • Number of events 51 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	32.2% 19/59 • Number of events 40 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Nervous system disorders HEADACHE	28.4% 33/116 • Number of events 46 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).	18.6% 11/59 • Number of events 17 • AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).