NCT00417079 · ADVERSE EVENTS

Adverse events

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer · Source last updated 2011-03-10

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: Adverse events are collected from the time to the first patient signed an informed consent form until 30 days after the administration of the last cycle of the study treatment to the last patient (i.e. 104 weeks).
Other-event reporting threshold: 5%

The safety analyses are performed on the safety population which includes all randomized patients who received at least part of one dose of the study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Mitoxantrone + Prednisone mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily	77 / 371	323 / 371	Not reported / Not reported
Cabazitaxel + Prednisone cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily	145 / 371	350 / 371	Not reported / Not reported

Group identifiers: EG000: Mitoxantrone + Prednisone · EG001: Cabazitaxel + Prednisone

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
4
num At Risk
371
group Id
EG001
num Affected
25
num At Risk
371
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
371
group Id
EG001
num Affected
18
num At Risk
371
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
3
num At Risk
371
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
371
group Id
EG001
num Affected
0
num At Risk
371
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
1
num At Risk
371
term
Ventricular fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
371
group Id
EG001
num Affected
0
num At Risk
371
term
Cardiotoxicity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
371
group Id
EG001
num Affected
0
num At Risk
371
term
Myocardial infarction

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
38
num At Risk
371
group Id
EG001
num Affected
66
num At Risk
371
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
18
num At Risk
371
group Id
EG001
num Affected
38
num At Risk
371
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
39
num At Risk
371
group Id
EG001
num Affected
170
num At Risk
371
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
84
num At Risk
371
group Id
EG001
num Affected
127
num At Risk
371
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
36
num At Risk
371
group Id
EG001
num Affected
80
num At Risk
371
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
56
num At Risk
371
group Id
EG001
num Affected
73
num At Risk
371
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
13
num At Risk
371
group Id
EG001
num Affected
38
num At Risk
371
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
6
num At Risk
371
group Id
EG001
num Affected
25
num At Risk
371
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
5
num At Risk
371
group Id
EG001
num Affected
20
num At Risk
371
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
102
num At Risk
371
group Id
EG001
num Affected
136
num At Risk
371
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
46
num At Risk
371
group Id
EG001
num Affected
76
num At Risk
371
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
22
num At Risk
371
group Id
EG001
num Affected
40
num At Risk
371
term
Pyrexia

Complete source fields

description

The safety analyses are performed on the safety population which includes all randomized patients who received at least part of one dose of the study drug.

event Groups

description
mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
id
EG000
other Num Affected
323
other Num At Risk
371
serious Num Affected
77
serious Num At Risk
371
title
Mitoxantrone + Prednisone
description
cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
id
EG001
other Num Affected
350
other Num At Risk
371
serious Num Affected
145
serious Num At Risk
371
title
Cabazitaxel + Prednisone

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
38
num At Risk
371
group Id
EG001
num Affected
66
num At Risk
371
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
18
num At Risk
371
group Id
EG001
num Affected
38
num At Risk
371
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
39
num At Risk
371
group Id
EG001
num Affected
170
num At Risk
371
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
84
num At Risk
371
group Id
EG001
num Affected
127
num At Risk
371
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
36
num At Risk
371
group Id
EG001
num Affected
80
num At Risk
371
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
56
num At Risk
371
group Id
EG001
num Affected
73
num At Risk
371
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
13
num At Risk
371
group Id
EG001
num Affected
38
num At Risk
371
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
6
num At Risk
371
group Id
EG001
num Affected
25
num At Risk
371
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
5
num At Risk
371
group Id
EG001
num Affected
20
num At Risk
371
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
102
num At Risk
371
group Id
EG001
num Affected
136
num At Risk
371
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
46
num At Risk
371
group Id
EG001
num Affected
76
num At Risk
371
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
22
num At Risk
371
group Id
EG001
num Affected
40
num At Risk
371
term
Pyrexia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
4
num At Risk
371
group Id
EG001
num Affected
25
num At Risk
371
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
371
group Id
EG001
num Affected
18
num At Risk
371
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
3
num At Risk
371
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
371
group Id
EG001
num Affected
0
num At Risk
371
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
2
num At Risk
371
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
371
group Id
EG001
num Affected
1
num At Risk
371
term
Ventricular fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
371
group Id
EG001
num Affected
0
num At Risk
371
term
Cardiotoxicity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
371
group Id
EG001
num Affected
0
num At Risk
371
term
Myocardial infarction

time Frame

Adverse events are collected from the time to the first patient signed an informed consent form until 30 days after the administration of the last cycle of the study treatment to the last patient (i.e. 104 weeks).

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