Trial Outcomes & Findings for Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy (NCT NCT00065442)
NCT ID: NCT00065442
Last Updated: 2010-09-06
Results Overview
Time from randomization until death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
512 participants
Primary outcome timeframe
Event-driven timeframe. Final analysis at 331 events.
Results posted on
2010-09-06
Participant Flow
Participants were randomized between August 2003 and November 2007 across 75 clinical trial sites.
Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
Participant milestones
| Measure |
APC-Placebo
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
|
Sipuleucel-T
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
341
|
|
Overall Study
COMPLETED
|
46
|
121
|
|
Overall Study
NOT COMPLETED
|
125
|
220
|
Reasons for withdrawal
| Measure |
APC-Placebo
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
|
Sipuleucel-T
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Death
|
121
|
210
|
|
Overall Study
Withdrawal by Subject
|
3
|
9
|
Baseline Characteristics
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Baseline characteristics by cohort
| Measure |
APC-Placebo
n=171 Participants
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
|
Sipuleucel-T
n=341 Participants
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
|
Total
n=512 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70.1 years
STANDARD_DEVIATION 9.0 • n=39 Participants
|
71.1 years
STANDARD_DEVIATION 8.9 • n=41 Participants
|
70.8 years
STANDARD_DEVIATION 8.9 • n=35 Participants
|
|
Age, Customized
|
70 years
n=39 Participants
|
72 years
n=41 Participants
|
71 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=39 Participants
|
341 Participants
n=41 Participants
|
512 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Event-driven timeframe. Final analysis at 331 events.Time from randomization until death due to any cause.
Outcome measures
| Measure |
APC-Placebo
n=171 Participants
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
|
Sipuleucel-T
n=341 Participants
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
|
|---|---|---|
|
Overall Survival
|
21.7 Months
Interval 17.7 to 23.8
|
25.8 Months
Interval 22.8 to 27.7
|
SECONDARY outcome
Timeframe: Analysis conducted at the time of overall survival analysisMeasured by imaging studies; confirmed by independent imaging review
Outcome measures
| Measure |
APC-Placebo
n=171 Participants
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
|
Sipuleucel-T
n=341 Participants
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
|
|---|---|---|
|
Time to Objective Disease Progression
|
14.4 Weeks
Interval 11.7 to 15.0
|
14.6 Weeks
Interval 11.7 to 15.6
|
Adverse Events
APC-Placebo
Serious events: 40 serious events
Other events: 162 other events
Deaths: 0 deaths
Sipuleucel-T
Serious events: 82 serious events
Other events: 334 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
APC-Placebo
n=168 participants at risk
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
|
Sipuleucel-T
n=338 participants at risk
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Angina pectoris
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Angina unstable
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.89%
3/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Cardiac tamponade
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Eye disorders
Diplopia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.89%
3/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
RECTAL OBSTRUCTION
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Asthenia
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Chest discomfort
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Chills
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Gait disturbance
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Infusion related reaction
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Pyrexia
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
1.8%
6/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Catheter bacteraemia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Cellulitis
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Sepsis
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Urinary tract infection
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Urinary tract infection Pseudomonal
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Urosepsis
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Device occlusion
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Investigations
Brain scan abnormal
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Investigations
Weight decreased
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.89%
3/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
2.4%
4/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
1.2%
4/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Brain mass
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.8%
3/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
1.8%
6/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Spinal cord compression
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
1.2%
4/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Syncope
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Bladder obstruction
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Haematuria
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Obstructive uropathy
|
1.2%
2/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Renal failure
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Renal failure acute
|
2.4%
4/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.59%
2/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
1.2%
4/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Reexpansion pulmonary oedema
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
3/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
3/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Haemorrhage
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Hypotension
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Pallor
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.30%
1/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Catheter related infection
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
0.00%
0/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
Other adverse events
| Measure |
APC-Placebo
n=168 participants at risk
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
|
Sipuleucel-T
n=338 participants at risk
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
21/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
14.8%
50/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
24/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
13.3%
45/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.1%
17/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
10.7%
36/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Nausea
|
20.8%
35/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
28.1%
95/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
20/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
17.8%
60/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Asthenia
|
7.7%
13/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
10.9%
37/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Chills
|
12.5%
21/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
54.1%
183/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Fatigue
|
38.1%
64/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
39.1%
132/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Influenza like illness
|
3.6%
6/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
9.8%
33/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Oedema peripheral
|
9.5%
16/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
9.5%
32/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Pain
|
7.1%
12/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
13.0%
44/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
General disorders
Pyrexia
|
13.7%
23/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
29.3%
99/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
9/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
4.4%
15/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
12/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
6.5%
22/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Citrate toxicity
|
20.2%
34/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
20.1%
68/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.4%
9/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
2.7%
9/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Investigations
Weight decreased
|
10.7%
18/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
5.9%
20/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.1%
27/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
7.1%
24/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
11/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
6.2%
21/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.8%
40/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
20.7%
70/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
36.3%
61/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
34.3%
116/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.7%
18/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
9.5%
32/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.0%
10/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
2.7%
9/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscles spasms
|
5.4%
9/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
7.1%
24/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.3%
19/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
9.8%
33/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.9%
20/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
13.0%
44/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
8/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
9.8%
33/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
7/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
5.9%
20/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.9%
25/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
14.5%
49/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Dizziness
|
9.5%
16/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
14.5%
49/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Headache
|
4.8%
8/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
16.0%
54/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Hypoaesthesia
|
3.0%
5/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
5.3%
18/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Paraesthesia
|
15.5%
26/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
13.3%
45/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Nervous system disorders
Paraesthesia oral
|
12.5%
21/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
12.1%
41/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Psychiatric disorders
Anxiety
|
8.3%
14/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
3.8%
13/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Psychiatric disorders
Depression
|
6.5%
11/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
2.4%
8/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Psychiatric disorders
Insomnia
|
7.1%
12/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
7.1%
24/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Haematuria
|
5.4%
9/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
9.2%
31/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Renal and urinary disorders
Hydronephrosis
|
7.1%
12/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
3.8%
13/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
8/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
8.3%
28/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.60%
1/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
5.3%
18/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
9/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
4.7%
16/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Hypertension
|
3.0%
5/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
7.4%
25/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
|
Vascular disorders
Hypotension
|
5.4%
9/168 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
5.3%
18/338 • From randomization until time of overall survival analysis.
Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A provision provides for sponsor review up to 45 days with the right to request modification based on disclosure of confidential information; extendable by 60 days to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER