NCT00104104 · ADVERSE EVENTS

Adverse events

A Multiple Myeloma Trial in Patients With Bone Metastases · Source last updated 2011-06-29

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: Not reported
Other-event reporting threshold: 5%

Because of GCP violations at Site 74, post-baseline data from that site are excluded from analyses, leaving 85 patients in the 15-minute infusion group and 84 patients in the 30-minute infusion group.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
15 - Minute Infusion Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.	30 / 85	74 / 85	Not reported / Not reported
30 - Minute Infusion Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.	35 / 84	76 / 84	Not reported / Not reported

Group identifiers: EG000: 15 - Minute Infusion · EG001: 30 - Minute Infusion

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 10.X
stats
group Id
EG000
num Affected
5
num At Risk
85
group Id
EG001
num Affected
2
num At Risk
84
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
4
num At Risk
84
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
0
num At Risk
84
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
0
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
0
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
0
num At Risk
85
group Id
EG001
num Affected
3
num At Risk
84
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
0
num At Risk
84
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
3
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
0
num At Risk
84
term
Atrioventricular block first degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
0
num At Risk
84
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
0
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Cardiac failure

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 10.X
stats
group Id
EG000
num Affected
16
num At Risk
85
group Id
EG001
num Affected
26
num At Risk
84
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
6
num At Risk
85
group Id
EG001
num Affected
12
num At Risk
84
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
4
num At Risk
85
group Id
EG001
num Affected
11
num At Risk
84
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
6
num At Risk
85
group Id
EG001
num Affected
5
num At Risk
84
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
20
num At Risk
85
group Id
EG001
num Affected
21
num At Risk
84
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
11
num At Risk
85
group Id
EG001
num Affected
19
num At Risk
84
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
5
num At Risk
85
group Id
EG001
num Affected
5
num At Risk
84
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
16
num At Risk
85
group Id
EG001
num Affected
25
num At Risk
84
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
8
num At Risk
85
group Id
EG001
num Affected
12
num At Risk
84
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
5
num At Risk
85
group Id
EG001
num Affected
10
num At Risk
84
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
6
num At Risk
85
group Id
EG001
num Affected
7
num At Risk
84
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
30
num At Risk
85
group Id
EG001
num Affected
41
num At Risk
84
term
Fatigue

Complete source fields

description

event Groups

description
Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
id
EG000
other Num Affected
74
other Num At Risk
85
serious Num Affected
30
serious Num At Risk
85
title
15 - Minute Infusion
description
Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
id
EG001
other Num Affected
76
other Num At Risk
84
serious Num Affected
35
serious Num At Risk
84
title
30 - Minute Infusion

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
16
num At Risk
85
group Id
EG001
num Affected
26
num At Risk
84
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
6
num At Risk
85
group Id
EG001
num Affected
12
num At Risk
84
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
4
num At Risk
85
group Id
EG001
num Affected
11
num At Risk
84
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
6
num At Risk
85
group Id
EG001
num Affected
5
num At Risk
84
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
20
num At Risk
85
group Id
EG001
num Affected
21
num At Risk
84
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
11
num At Risk
85
group Id
EG001
num Affected
19
num At Risk
84
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
5
num At Risk
85
group Id
EG001
num Affected
5
num At Risk
84
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
16
num At Risk
85
group Id
EG001
num Affected
25
num At Risk
84
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
8
num At Risk
85
group Id
EG001
num Affected
12
num At Risk
84
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
5
num At Risk
85
group Id
EG001
num Affected
10
num At Risk
84
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
6
num At Risk
85
group Id
EG001
num Affected
7
num At Risk
84
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
30
num At Risk
85
group Id
EG001
num Affected
41
num At Risk
84
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
5
num At Risk
85
group Id
EG001
num Affected
2
num At Risk
84
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
4
num At Risk
84
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
0
num At Risk
84
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
0
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
0
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
0
num At Risk
85
group Id
EG001
num Affected
3
num At Risk
84
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
0
num At Risk
84
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
3
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
0
num At Risk
84
term
Atrioventricular block first degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
0
num At Risk
84
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
1
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.X
stats
group Id
EG000
num Affected
0
num At Risk
85
group Id
EG001
num Affected
1
num At Risk
84
term
Cardiac failure

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