NCT00330759 · ADVERSE EVENTS

Adverse events

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma. · Source last updated 2022-11-07

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 9 months
Other-event reporting threshold: 5%

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Zoledronic Acid 4 mg Q4W Not reported	581 / 878	767 / 878	Not reported / Not reported
Denosumab 120 mg Q4W Not reported	552 / 878	751 / 878	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
0
num At Risk
878
group Id
EG001
num Affected
1
num At Risk
878
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
49
num At Risk
878
group Id
EG001
num Affected
25
num At Risk
878
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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Anaemia of chronic disease
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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Aplastic 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
878
group Id
EG001
num Affected
1
num At Risk
878
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
2
num At Risk
878
group Id
EG001
num Affected
2
num At Risk
878
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
878
group Id
EG001
num Affected
0
num At Risk
878
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
1
num At Risk
878
group Id
EG001
num Affected
0
num At Risk
878
term
Erythropenia
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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
31
num At Risk
878
group Id
EG001
num Affected
21
num At Risk
878
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
0
num At Risk
878
group Id
EG001
num Affected
1
num At Risk
878
term
Granulocytopenia
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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Hyperviscosity syndrome

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
264
num At Risk
878
group Id
EG001
num Affected
234
num At Risk
878
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
68
num At Risk
878
group Id
EG001
num Affected
50
num At Risk
878
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
100
num At Risk
878
group Id
EG001
num Affected
90
num At Risk
878
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
86
num At Risk
878
group Id
EG001
num Affected
90
num At Risk
878
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
86
num At Risk
878
group Id
EG001
num Affected
84
num At Risk
878
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
38
num At Risk
878
group Id
EG001
num Affected
47
num At Risk
878
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
209
num At Risk
878
group Id
EG001
num Affected
188
num At Risk
878
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
165
num At Risk
878
group Id
EG001
num Affected
163
num At Risk
878
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
260
num At Risk
878
group Id
EG001
num Affected
244
num At Risk
878
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
167
num At Risk
878
group Id
EG001
num Affected
174
num At Risk
878
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
171
num At Risk
878
group Id
EG001
num Affected
156
num At Risk
878
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
85
num At Risk
878
group Id
EG001
num Affected
92
num At Risk
878
term
Chest pain

Complete source fields

description

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

event Groups

id
EG000
other Num Affected
767
other Num At Risk
878
serious Num Affected
581
serious Num At Risk
878
title
Zoledronic Acid 4 mg Q4W
id
EG001
other Num Affected
751
other Num At Risk
878
serious Num Affected
552
serious Num At Risk
878
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
264
num At Risk
878
group Id
EG001
num Affected
234
num At Risk
878
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
68
num At Risk
878
group Id
EG001
num Affected
50
num At Risk
878
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
100
num At Risk
878
group Id
EG001
num Affected
90
num At Risk
878
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
86
num At Risk
878
group Id
EG001
num Affected
90
num At Risk
878
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
86
num At Risk
878
group Id
EG001
num Affected
84
num At Risk
878
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
38
num At Risk
878
group Id
EG001
num Affected
47
num At Risk
878
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
209
num At Risk
878
group Id
EG001
num Affected
188
num At Risk
878
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
165
num At Risk
878
group Id
EG001
num Affected
163
num At Risk
878
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
260
num At Risk
878
group Id
EG001
num Affected
244
num At Risk
878
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
167
num At Risk
878
group Id
EG001
num Affected
174
num At Risk
878
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
171
num At Risk
878
group Id
EG001
num Affected
156
num At Risk
878
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
85
num At Risk
878
group Id
EG001
num Affected
92
num At Risk
878
term
Chest pain

serious Events

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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
49
num At Risk
878
group Id
EG001
num Affected
25
num At Risk
878
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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Anaemia of chronic disease
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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Aplastic 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
878
group Id
EG001
num Affected
1
num At Risk
878
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
2
num At Risk
878
group Id
EG001
num Affected
2
num At Risk
878
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
878
group Id
EG001
num Affected
0
num At Risk
878
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
1
num At Risk
878
group Id
EG001
num Affected
0
num At Risk
878
term
Erythropenia
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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
31
num At Risk
878
group Id
EG001
num Affected
21
num At Risk
878
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
0
num At Risk
878
group Id
EG001
num Affected
1
num At Risk
878
term
Granulocytopenia
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
878
group Id
EG001
num Affected
1
num At Risk
878
term
Hyperviscosity syndrome

time Frame

up to 2 years 9 months

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Preserved source evidence · Not medical advice