NCT00065442 · ADVERSE EVENTS

Adverse events

Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy · Source last updated 2010-09-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From randomization until time of overall survival analysis.
Other-event reporting threshold: 5%

Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	40 / 168	162 / 168	Not reported / Not reported
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.	82 / 338	334 / 338	Not reported / Not reported

Group identifiers: EG000: APC-Placebo · EG001: Sipuleucel-T

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
2
num At Risk
338
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
0
num At Risk
338
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
0
num At Risk
338
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
3
num At Risk
338
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Bundle branch block left
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Cardiac arrest

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
21
num At Risk
168
group Id
EG001
num Affected
50
num At Risk
338
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
24
num At Risk
168
group Id
EG001
num Affected
45
num At Risk
338
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
17
num At Risk
168
group Id
EG001
num Affected
36
num At Risk
338
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
35
num At Risk
168
group Id
EG001
num Affected
95
num At Risk
338
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
20
num At Risk
168
group Id
EG001
num Affected
60
num At Risk
338
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
13
num At Risk
168
group Id
EG001
num Affected
37
num At Risk
338
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
21
num At Risk
168
group Id
EG001
num Affected
183
num At Risk
338
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
64
num At Risk
168
group Id
EG001
num Affected
132
num At Risk
338
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
6
num At Risk
168
group Id
EG001
num Affected
33
num At Risk
338
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
16
num At Risk
168
group Id
EG001
num Affected
32
num At Risk
338
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
12
num At Risk
168
group Id
EG001
num Affected
44
num At Risk
338
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
23
num At Risk
168
group Id
EG001
num Affected
99
num At Risk
338
term
Pyrexia

Complete source fields

description

Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.

event Groups

description
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.
id
EG000
other Num Affected
162
other Num At Risk
168
serious Num Affected
40
serious Num At Risk
168
title
APC-Placebo
description
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.
id
EG001
other Num Affected
334
other Num At Risk
338
serious Num Affected
82
serious Num At Risk
338
title
Sipuleucel-T

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
21
num At Risk
168
group Id
EG001
num Affected
50
num At Risk
338
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
24
num At Risk
168
group Id
EG001
num Affected
45
num At Risk
338
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
17
num At Risk
168
group Id
EG001
num Affected
36
num At Risk
338
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
35
num At Risk
168
group Id
EG001
num Affected
95
num At Risk
338
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
20
num At Risk
168
group Id
EG001
num Affected
60
num At Risk
338
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
13
num At Risk
168
group Id
EG001
num Affected
37
num At Risk
338
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
21
num At Risk
168
group Id
EG001
num Affected
183
num At Risk
338
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
64
num At Risk
168
group Id
EG001
num Affected
132
num At Risk
338
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
6
num At Risk
168
group Id
EG001
num Affected
33
num At Risk
338
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
16
num At Risk
168
group Id
EG001
num Affected
32
num At Risk
338
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
12
num At Risk
168
group Id
EG001
num Affected
44
num At Risk
338
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
23
num At Risk
168
group Id
EG001
num Affected
99
num At Risk
338
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
2
num At Risk
338
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
0
num At Risk
338
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
0
num At Risk
338
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
168
group Id
EG001
num Affected
3
num At Risk
338
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Bundle branch block left
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
168
group Id
EG001
num Affected
1
num At Risk
338
term
Cardiac arrest

time Frame

From randomization until time of overall survival analysis.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice