NCT01308567 · ADVERSE EVENTS

Adverse events

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer · Source last updated 2019-06-05

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: All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 83 months) regardless of seriousness or relationship to investigational product.
Other-event reporting threshold: 5%

Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population, which was randomized participants who received study drug and analyzed according to the treatment actually received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Docetaxel 75 mg/m^2 Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	126 / 387	353 / 387	Not reported / Not reported
Cabazitaxel 20 mg/m^2 Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	127 / 369	323 / 369	Not reported / Not reported
Cabazitaxel 25 mg/m^2 Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.	188 / 391	354 / 391	Not reported / Not reported

Group identifiers: EG000: Docetaxel 75 mg/m^2 · EG001: Cabazitaxel 20 mg/m^2 · EG002: Cabazitaxel 25 mg/m^2

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
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Abscess intestinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Abscess jaw
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Abscess oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
1
num At Risk
391
term
Anal abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Appendicitis perforated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Cholecystitis infective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
2
num At Risk
391
term
Clostridium difficile colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Clostridium difficile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
1
num At Risk
391
term
Cystitis

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
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
25
num At Risk
387
group Id
EG001
num Affected
19
num At Risk
369
group Id
EG002
num Affected
15
num At Risk
391
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
7
num At Risk
387
group Id
EG001
num Affected
35
num At Risk
369
group Id
EG002
num Affected
33
num At Risk
391
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
8
num At Risk
387
group Id
EG001
num Affected
11
num At Risk
369
group Id
EG002
num Affected
25
num At Risk
391
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
66
num At Risk
387
group Id
EG001
num Affected
50
num At Risk
369
group Id
EG002
num Affected
74
num At Risk
391
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
28
num At Risk
387
group Id
EG001
num Affected
24
num At Risk
369
group Id
EG002
num Affected
20
num At Risk
391
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
25
num At Risk
387
group Id
EG001
num Affected
27
num At Risk
369
group Id
EG002
num Affected
34
num At Risk
391
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
70
num At Risk
387
group Id
EG001
num Affected
41
num At Risk
369
group Id
EG002
num Affected
59
num At Risk
391
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
31
num At Risk
387
group Id
EG001
num Affected
21
num At Risk
369
group Id
EG002
num Affected
27
num At Risk
391
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
24
num At Risk
387
group Id
EG001
num Affected
25
num At Risk
369
group Id
EG002
num Affected
14
num At Risk
391
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
97
num At Risk
387
group Id
EG001
num Affected
43
num At Risk
369
group Id
EG002
num Affected
48
num At Risk
391
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
37
num At Risk
387
group Id
EG001
num Affected
8
num At Risk
369
group Id
EG002
num Affected
3
num At Risk
391
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
16
num At Risk
387
group Id
EG001
num Affected
20
num At Risk
369
group Id
EG002
num Affected
12
num At Risk
391
term
Hypertension

Complete source fields

description

event Groups

description
Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
EG000
other Num Affected
353
other Num At Risk
387
serious Num Affected
126
serious Num At Risk
387
title
Docetaxel 75 mg/m^2
description
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
EG001
other Num Affected
323
other Num At Risk
369
serious Num Affected
127
serious Num At Risk
369
title
Cabazitaxel 20 mg/m^2
description
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
EG002
other Num Affected
354
other Num At Risk
391
serious Num Affected
188
serious Num At Risk
391
title
Cabazitaxel 25 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
25
num At Risk
387
group Id
EG001
num Affected
19
num At Risk
369
group Id
EG002
num Affected
15
num At Risk
391
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
7
num At Risk
387
group Id
EG001
num Affected
35
num At Risk
369
group Id
EG002
num Affected
33
num At Risk
391
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
8
num At Risk
387
group Id
EG001
num Affected
11
num At Risk
369
group Id
EG002
num Affected
25
num At Risk
391
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
66
num At Risk
387
group Id
EG001
num Affected
50
num At Risk
369
group Id
EG002
num Affected
74
num At Risk
391
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
28
num At Risk
387
group Id
EG001
num Affected
24
num At Risk
369
group Id
EG002
num Affected
20
num At Risk
391
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
25
num At Risk
387
group Id
EG001
num Affected
27
num At Risk
369
group Id
EG002
num Affected
34
num At Risk
391
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
70
num At Risk
387
group Id
EG001
num Affected
41
num At Risk
369
group Id
EG002
num Affected
59
num At Risk
391
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
31
num At Risk
387
group Id
EG001
num Affected
21
num At Risk
369
group Id
EG002
num Affected
27
num At Risk
391
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
24
num At Risk
387
group Id
EG001
num Affected
25
num At Risk
369
group Id
EG002
num Affected
14
num At Risk
391
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
97
num At Risk
387
group Id
EG001
num Affected
43
num At Risk
369
group Id
EG002
num Affected
48
num At Risk
391
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
37
num At Risk
387
group Id
EG001
num Affected
8
num At Risk
369
group Id
EG002
num Affected
3
num At Risk
391
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
16
num At Risk
387
group Id
EG001
num Affected
20
num At Risk
369
group Id
EG002
num Affected
12
num At Risk
391
term
Hypertension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Abscess intestinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Abscess jaw
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Abscess oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
1
num At Risk
391
term
Anal abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Appendicitis perforated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
1
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Cholecystitis infective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
2
num At Risk
391
term
Clostridium difficile colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
1
num At Risk
369
group Id
EG002
num Affected
0
num At Risk
391
term
Clostridium difficile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDra 21.0
stats
group Id
EG000
num Affected
0
num At Risk
387
group Id
EG001
num Affected
0
num At Risk
369
group Id
EG002
num Affected
1
num At Risk
391
term
Cystitis

time Frame

All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 83 months) regardless of seriousness or relationship to investigational product.

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Preserved source evidence · Not medical advice