NCT00321464 · ADVERSE EVENTS

Adverse events

A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects. · Source last updated 2022-11-08

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 2 years 10 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	471 / 1013	941 / 1013	Not reported / Not reported
Denosumab 120 mg Q4W Not reported	453 / 1020	924 / 1020	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 12.0
stats
group Id
EG000
num Affected
32
num At Risk
1013
group Id
EG001
num Affected
27
num At Risk
1020
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
1013
group Id
EG001
num Affected
1
num At Risk
1020
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
1013
group Id
EG001
num Affected
4
num At Risk
1020
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
1013
group Id
EG001
num Affected
0
num At Risk
1020
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
22
num At Risk
1013
group Id
EG001
num Affected
17
num At Risk
1020
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
1013
group Id
EG001
num Affected
0
num At Risk
1020
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
1013
group Id
EG001
num Affected
0
num At Risk
1020
term
Heparin-induced thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
6
num At Risk
1013
group Id
EG001
num Affected
6
num At Risk
1020
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
1013
group Id
EG001
num Affected
1
num At Risk
1020
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
1013
group Id
EG001
num Affected
0
num At Risk
1020
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
14
num At Risk
1013
group Id
EG001
num Affected
16
num At Risk
1020
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
1013
group Id
EG001
num Affected
5
num At Risk
1020
term
Pancytopenia

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 12.0
stats
group Id
EG000
num Affected
217
num At Risk
1013
group Id
EG001
num Affected
183
num At Risk
1020
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
72
num At Risk
1013
group Id
EG001
num Affected
78
num At Risk
1020
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
118
num At Risk
1013
group Id
EG001
num Affected
114
num At Risk
1020
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
53
num At Risk
1013
group Id
EG001
num Affected
62
num At Risk
1020
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
113
num At Risk
1013
group Id
EG001
num Affected
114
num At Risk
1020
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
80
num At Risk
1013
group Id
EG001
num Affected
68
num At Risk
1020
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
203
num At Risk
1013
group Id
EG001
num Affected
175
num At Risk
1020
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
198
num At Risk
1013
group Id
EG001
num Affected
223
num At Risk
1020
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
73
num At Risk
1013
group Id
EG001
num Affected
52
num At Risk
1020
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
377
num At Risk
1013
group Id
EG001
num Affected
350
num At Risk
1020
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
70
num At Risk
1013
group Id
EG001
num Affected
90
num At Risk
1020
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
37
num At Risk
1013
group Id
EG001
num Affected
57
num At Risk
1020
term
Toothache

Complete source fields

description

event Groups

id
EG000
other Num Affected
941
other Num At Risk
1013
serious Num Affected
471
serious Num At Risk
1013
title
Zoledronic Acid 4 mg Q4W
id
EG001
other Num Affected
924
other Num At Risk
1020
serious Num Affected
453
serious Num At Risk
1020
title
Denosumab 120 mg Q4W

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
217
num At Risk
1013
group Id
EG001
num Affected
183
num At Risk
1020
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
72
num At Risk
1013
group Id
EG001
num Affected
78
num At Risk
1020
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
118
num At Risk
1013
group Id
EG001
num Affected
114
num At Risk
1020
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
53
num At Risk
1013
group Id
EG001
num Affected
62
num At Risk
1020
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
113
num At Risk
1013
group Id
EG001
num Affected
114
num At Risk
1020
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
80
num At Risk
1013
group Id
EG001
num Affected
68
num At Risk
1020
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
203
num At Risk
1013
group Id
EG001
num Affected
175
num At Risk
1020
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
198
num At Risk
1013
group Id
EG001
num Affected
223
num At Risk
1020
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
73
num At Risk
1013
group Id
EG001
num Affected
52
num At Risk
1020
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
377
num At Risk
1013
group Id
EG001
num Affected
350
num At Risk
1020
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
70
num At Risk
1013
group Id
EG001
num Affected
90
num At Risk
1020
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
37
num At Risk
1013
group Id
EG001
num Affected
57
num At Risk
1020
term
Toothache

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
32
num At Risk
1013
group Id
EG001
num Affected
27
num At Risk
1020
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
1013
group Id
EG001
num Affected
1
num At Risk
1020
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
1013
group Id
EG001
num Affected
4
num At Risk
1020
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
1013
group Id
EG001
num Affected
0
num At Risk
1020
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
22
num At Risk
1013
group Id
EG001
num Affected
17
num At Risk
1020
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
1013
group Id
EG001
num Affected
0
num At Risk
1020
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
1013
group Id
EG001
num Affected
0
num At Risk
1020
term
Heparin-induced thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
6
num At Risk
1013
group Id
EG001
num Affected
6
num At Risk
1020
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
1013
group Id
EG001
num Affected
1
num At Risk
1020
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
1013
group Id
EG001
num Affected
0
num At Risk
1020
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
14
num At Risk
1013
group Id
EG001
num Affected
16
num At Risk
1020
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
1013
group Id
EG001
num Affected
5
num At Risk
1020
term
Pancytopenia

time Frame

up to 2 years 10 months

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Preserved source evidence · Not medical advice