NCT00321620 · ADVERSE EVENTS

Adverse events

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer · Source last updated 2018-08-29

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: up to 3 years 5 months
Other-event reporting threshold: 5%

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to zoledronic acid and received denosumab as the 1st investigational product was analyzed on the denosumab arm for safety analyses.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Zoledronic Acid 4 mg Q4W Not reported	568 / 945	853 / 945	Not reported / Not reported
Denosumab 120 mg Q4W Not reported	594 / 943	844 / 943	Not reported / Not reported

Group identifiers: EG000: Zoledronic Acid 4 mg Q4W · EG001: Denosumab 120 mg Q4W

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 12.1
stats
group Id
EG000
num Affected
82
num At Risk
945
group Id
EG001
num Affected
108
num At Risk
943
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
945
group Id
EG001
num Affected
0
num At Risk
943
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
945
group Id
EG001
num Affected
0
num At Risk
943
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
945
group Id
EG001
num Affected
3
num At Risk
943
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
945
group Id
EG001
num Affected
0
num At Risk
943
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
8
num At Risk
945
group Id
EG001
num Affected
8
num At Risk
943
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
945
group Id
EG001
num Affected
1
num At Risk
943
term
Haemorrhagic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
945
group Id
EG001
num Affected
1
num At Risk
943
term
Heparin-induced thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
945
group Id
EG001
num Affected
1
num At Risk
943
term
Hypercoagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
945
group Id
EG001
num Affected
3
num At Risk
943
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
945
group Id
EG001
num Affected
3
num At Risk
943
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
945
group Id
EG001
num Affected
10
num At Risk
943
term
Neutropenia

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 12.1
stats
group Id
EG000
num Affected
313
num At Risk
945
group Id
EG001
num Affected
300
num At Risk
943
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
57
num At Risk
945
group Id
EG001
num Affected
67
num At Risk
943
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
247
num At Risk
945
group Id
EG001
num Affected
233
num At Risk
943
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
143
num At Risk
945
group Id
EG001
num Affected
174
num At Risk
943
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
242
num At Risk
945
group Id
EG001
num Affected
271
num At Risk
943
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
138
num At Risk
945
group Id
EG001
num Affected
155
num At Risk
943
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
226
num At Risk
945
group Id
EG001
num Affected
219
num At Risk
943
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
62
num At Risk
945
group Id
EG001
num Affected
67
num At Risk
943
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
217
num At Risk
945
group Id
EG001
num Affected
247
num At Risk
943
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
171
num At Risk
945
group Id
EG001
num Affected
187
num At Risk
943
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
85
num At Risk
945
group Id
EG001
num Affected
78
num At Risk
943
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
121
num At Risk
945
group Id
EG001
num Affected
87
num At Risk
943
term
Pyrexia

Complete source fields

description

event Groups

id
EG000
other Num Affected
853
other Num At Risk
945
serious Num Affected
568
serious Num At Risk
945
title
Zoledronic Acid 4 mg Q4W
id
EG001
other Num Affected
844
other Num At Risk
943
serious Num Affected
594
serious Num At Risk
943
title
Denosumab 120 mg Q4W

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
313
num At Risk
945
group Id
EG001
num Affected
300
num At Risk
943
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
57
num At Risk
945
group Id
EG001
num Affected
67
num At Risk
943
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
247
num At Risk
945
group Id
EG001
num Affected
233
num At Risk
943
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
143
num At Risk
945
group Id
EG001
num Affected
174
num At Risk
943
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
242
num At Risk
945
group Id
EG001
num Affected
271
num At Risk
943
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
138
num At Risk
945
group Id
EG001
num Affected
155
num At Risk
943
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
226
num At Risk
945
group Id
EG001
num Affected
219
num At Risk
943
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
62
num At Risk
945
group Id
EG001
num Affected
67
num At Risk
943
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
217
num At Risk
945
group Id
EG001
num Affected
247
num At Risk
943
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
171
num At Risk
945
group Id
EG001
num Affected
187
num At Risk
943
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
85
num At Risk
945
group Id
EG001
num Affected
78
num At Risk
943
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
121
num At Risk
945
group Id
EG001
num Affected
87
num At Risk
943
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
82
num At Risk
945
group Id
EG001
num Affected
108
num At Risk
943
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
945
group Id
EG001
num Affected
0
num At Risk
943
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
945
group Id
EG001
num Affected
0
num At Risk
943
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
945
group Id
EG001
num Affected
3
num At Risk
943
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
945
group Id
EG001
num Affected
0
num At Risk
943
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
8
num At Risk
945
group Id
EG001
num Affected
8
num At Risk
943
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
945
group Id
EG001
num Affected
1
num At Risk
943
term
Haemorrhagic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
945
group Id
EG001
num Affected
1
num At Risk
943
term
Heparin-induced thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
945
group Id
EG001
num Affected
1
num At Risk
943
term
Hypercoagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
945
group Id
EG001
num Affected
3
num At Risk
943
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
945
group Id
EG001
num Affected
3
num At Risk
943
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
945
group Id
EG001
num Affected
10
num At Risk
943
term
Neutropenia

time Frame

up to 3 years 5 months

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

Preserved source evidence · Not medical advice