Trial Outcomes & Findings for A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (NCT NCT01306890)

Last Updated: 2019-06-07

Results Overview

The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.

Recruitment status

COMPLETED

Target enrollment

1976 participants

Primary outcome timeframe

Every 3 months for a minimum of 3 years

Results posted on

2019-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Sipuleucel-T sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Overall Study STARTED	1976
Overall Study COMPLETED	457
Overall Study NOT COMPLETED	1519

Reasons for withdrawal

Reasons for withdrawal
Measure	Sipuleucel-T sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Overall Study Adverse Event	2
Overall Study Death	1223
Overall Study Lost to Follow-up	58
Overall Study Withdrawal by Subject	88
Overall Study Unspecified reasons	104
Overall Study Study Termination	3
Overall Study No discontinuation documentation	41

Baseline Characteristics

A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sipuleucel-T n=1902 Participants sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	441 Participants n=99 Participants
Age, Categorical >=65 years	1461 Participants n=99 Participants
Age, Continuous	71.9 Years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1902 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=99 Participants
Race (NIH/OMB) Asian	22 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=99 Participants
Race (NIH/OMB) Black or African American	221 Participants n=99 Participants
Race (NIH/OMB) White	1649 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	1902 Participants n=99 Participants
Weight	91.97 kilogram STANDARD_DEVIATION 17.67 • n=99 Participants
Height	176.59 Centimeters STANDARD_DEVIATION 7.29 • n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0=Fully Active; No restrictions	1265 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1= Restricted Strenuous Activity	571 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 2= Capable of selfcare	34 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 3= Capable of limited selfcare	8 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG Not Reported	24 Participants n=99 Participants
Primary Gleason Score Gleason Score ≤3	486 Participants n=99 Participants
Primary Gleason Score Gleason Score ≥4	1145 Participants n=99 Participants
Primary Gleason Score Primary Gleason Score Data Not Recorded	271 Participants n=99 Participants
Gleason Sum Reported Gleason Score ≤7	790 Participants n=99 Participants
Gleason Sum Reported Gleason Score ≥8	963 Participants n=99 Participants
Gleason Sum Reported Gleson Sum Data Not Recorded	149 Participants n=99 Participants
Comorbidity Score High	220 Participants n=99 Participants
Comorbidity Score Low	1682 Participants n=99 Participants
Alkaline phosphatase	117.8 U/L STANDARD_DEVIATION 163.2 • n=99 Participants
Hemoglobin	12.68 g/dL STANDARD_DEVIATION 1.48 • n=99 Participants
Lactate dehydrogenase	225.1 U/L STANDARD_DEVIATION 211.6 • n=99 Participants
Prostate-specific antigen (PSA)	71.93 ng/mL STANDARD_DEVIATION 287.89 • n=99 Participants

PRIMARY outcome

Timeframe: Every 3 months for a minimum of 3 years

Outcome measures

Outcome measures
Measure	Sipuleucel-T n=1902 Participants sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects	1.2 events per 100 patient years

SECONDARY outcome

Timeframe: Every 3 months for a minimum of 3 years

To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Sipuleucel-T n=1902 Participants sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Survival	30.7 months Interval 28.6 to 32.2

Adverse Events

Sipuleucel-T

Serious events: 260 serious events

Other events: 12 other events

Deaths: 1223 deaths

Serious adverse events

Serious adverse events
Measure	Sipuleucel-T n=1902 participants at risk sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Renal and urinary disorders Renal injury	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Ureteric obstruction	0.05% 1/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Urethral stenosis	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Urinary retention	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Prostatomegaly	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Blood and lymphatic system disorders Anaemia	0.37% 7/1902 • Number of events 14 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Blood and lymphatic system disorders Febrile neutropenia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Blood and lymphatic system disorders Leukocytosis	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Blood and lymphatic system disorders Microcytic anaemia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Blood and lymphatic system disorders Retroperitoneal lymphadenopathy	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Blood and lymphatic system disorders Thrombocytopenia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Acute myocardial infarction	0.11% 2/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Angina unstable	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Atrial fibrillation	0.16% 3/1902 • Number of events 8 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Cardiac failure congestive	0.21% 4/1902 • Number of events 7 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Cardio-respiratory arrest	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Myocardial infarction	0.32% 6/1902 • Number of events 7 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Sinus bradycardia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Supraventricular tachycardia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Tachycardia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Cardiac disorders Ventricular tachycardia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Eye disorders Papilloedema	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Colitis	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Abdominal pain	0.05% 1/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Colonic pseudo-obstruction	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Constipation	0.16% 3/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Diarrhoea	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Duodenal ulcer	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Gastric haemorrhage	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Hiatus hernia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Intestinal obstruction	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Intestinal perforation	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Intestinal ulcer	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Nausea	0.21% 4/1902 • Number of events 10 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Pancreatitis	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Gastrointestinal disorders Vomiting	0.21% 4/1902 • Number of events 8 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Asthenia	0.16% 3/1902 • Number of events 6 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Chest pain	0.32% 6/1902 • Number of events 8 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Chills	0.68% 13/1902 • Number of events 18 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Death	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Disease progression	1.5% 28/1902 • Number of events 37 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Gait disturbance	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Impaired healing	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Pain	0.05% 1/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
General disorders Pyrexia	0.32% 6/1902 • Number of events 10 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Hepatobiliary disorders Hepatic failure	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Hepatobiliary disorders Jaundice	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Bacteraemia	0.16% 3/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Bacterial infection	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Bronchitis	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Clostridium difficile colitis	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Device related infection	0.53% 10/1902 • Number of events 10 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Device related sepsis	0.21% 4/1902 • Number of events 4 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Endocarditis staphylococcal	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Infection	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Intervertebral discitis	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Ludwig angina	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Osteomyelitis	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Otitis media acute	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Pneumococcal bacteraemia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Pneumonia	0.26% 5/1902 • Number of events 7 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Salmonella sepsis	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Sepsis	0.11% 2/1902 • Number of events 5 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Septic shock	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Staphylococcal bacteraemia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Tooth abscess	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Upper respiratory tract infection	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Urinary tract infection	0.11% 2/1902 • Number of events 8 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Infections and infestations Urinary tract infection staphylococcal	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Cystitis radiation	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Fall	0.16% 3/1902 • Number of events 8 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Femur fracture	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Head injury	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Hip fracture	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Infusion related reaction	0.16% 3/1902 • Number of events 4 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Joint dislocation	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Laceration	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Ligament sprain	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Post concussion syndrome	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Skull fracture	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Spinal compression fracture	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Spinal fracture	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Subdural haematoma	0.32% 6/1902 • Number of events 13 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Investigations Blood potassium increased	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Investigations Blood pressure decreased	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Investigations Blood pressure increased	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Investigations Haemoglobin decreased	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Investigations Oxygen saturation decreased	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Investigations Troponin increased	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Investigations White blood cell count increased	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Dehydration	0.21% 4/1902 • Number of events 11 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Failure to thrive	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Hyperkalaemia	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Hypocalcaemia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Hypoglycaemia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Hypokalaemia	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Hyponatraemia	0.05% 1/1902 • Number of events 4 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Hypovolaemia	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Metabolism and nutrition disorders Malnutrition	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Musculoskeletal and connective tissue disorders Back pain	0.16% 3/1902 • Number of events 7 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Musculoskeletal and connective tissue disorders Flank pain	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Musculoskeletal and connective tissue disorders Neck pain	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage IV	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Cauda equina syndrome	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Central nervous system haemorrhage	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Cerebral haemorrhage	0.26% 5/1902 • Number of events 6 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Cerebral infarction	0.21% 4/1902 • Number of events 5 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Cerebrovascular accident	0.84% 16/1902 • Number of events 20 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Dizziness	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Dysarthria	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Embolic stroke	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Encephalopathy	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Haemorrhage intracranial	0.21% 4/1902 • Number of events 4 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Haemorrhagic stroke	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Headache	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Hemiparesis	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Hemiplegia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Hydrocephalus	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Hydromyelia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Intracranial mass	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Ischaemic stroke	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Lacunar infarction	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Lethargy	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Paralysis	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Partial seizures	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Peroneal nerve palsy	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Presyncope	0.16% 3/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Seizure	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Spinal cord compression	0.21% 4/1902 • Number of events 4 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Subarachnoid haemorrhage	0.05% 1/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Syncope	0.63% 12/1902 • Number of events 12 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Thalamic infarction	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Transient ischaemic attack	0.32% 6/1902 • Number of events 7 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Psychiatric disorders Acute psychosis	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Psychiatric disorders Anxiety	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Psychiatric disorders Confusional state	0.16% 3/1902 • Number of events 5 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Psychiatric disorders Depression	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Psychiatric disorders Mental status changes	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Acute kidney injury	0.42% 8/1902 • Number of events 13 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Bladder obstruction	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Haematuria	0.16% 3/1902 • Number of events 5 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Hydronephrosis	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Nephropathy	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Obstructive uropathy	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Renal and urinary disorders Renal failure	0.11% 2/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Reproductive system and breast disorders Cough	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.37% 7/1902 • Number of events 10 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.42% 8/1902 • Number of events 11 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Surgical and medical procedures Fracture reduction	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Surgical and medical procedures Hip arthroplasty	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Surgical and medical procedures Urethral stent insertion	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Aneurysm	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Blood pressure fluctuation	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Deep vein thrombosis	0.42% 8/1902 • Number of events 10 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Hot flush	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Hypotension	0.16% 3/1902 • Number of events 5 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Ischaemia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Jugular vein thrombosis	0.05% 1/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Orthostatic hypotension	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Vascular disorders Thrombosis	0.05% 1/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.

Other adverse events

Other adverse events
Measure	Sipuleucel-T n=1902 participants at risk sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Injury, poisoning and procedural complications Subdural haematoma	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Aphasia	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Cerebral haemorrhage	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Cerebral infarction	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Cerebrovascular accident	0.11% 2/1902 • Number of events 3 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Ischaemic stroke	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Seizure	0.05% 1/1902 • Number of events 1 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
Nervous system disorders Transient ischaemic attack	0.11% 2/1902 • Number of events 2 • All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.

Additional Information

Shabnam Vaziri

Dendreon

Phone: 206-455-2323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place