NCT00079001 · ADVERSE EVENTS

Adverse events

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases · Source last updated 2020-05-12

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: 0%

All patients that reported adverse events were used to summarize the adverse events, data is available on 618 participants. Participants that were not assessed for adverse events were not included in the adverse event table.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Zoledronic Acid + Androgen Deprivation Therapy 4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).	60 / 310	269 / 310	Not reported / Not reported
Placebo + Androgen Deprivation Therapy Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.	61 / 308	266 / 308	Not reported / Not reported

Group identifiers: EG000: Zoledronic Acid + Androgen Deprivation Therapy · EG001: Placebo + Androgen Deprivation Therapy

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 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
310
num Events
9
group Id
EG001
num Affected
6
num At Risk
308
num Events
6
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
3
num At Risk
308
num Events
3
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
2
num At Risk
308
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
310
num Events
3
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
2
num At Risk
308
num Events
5
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
5
num At Risk
310
num Events
5
group Id
EG001
num Affected
2
num At Risk
308
num Events
2
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Sick sinus syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Sinus tachycardia

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 6
stats
group Id
EG000
num Affected
8
num At Risk
310
num Events
14
group Id
EG001
num Affected
6
num At Risk
308
num Events
6
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
310
num Events
2
group Id
EG001
num Affected
2
num At Risk
308
num Events
2
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Cardiac valve disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Cardiopulmonary arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
2
num At Risk
308
num Events
2
term
Palpitations

Complete source fields

description

event Groups

description
4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
id
EG000
other Num Affected
269
other Num At Risk
310
serious Num Affected
60
serious Num At Risk
310
title
Zoledronic Acid + Androgen Deprivation Therapy
description
Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
id
EG001
other Num Affected
266
other Num At Risk
308
serious Num Affected
61
serious Num At Risk
308
title
Placebo + Androgen Deprivation Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
8
num At Risk
310
num Events
14
group Id
EG001
num Affected
6
num At Risk
308
num Events
6
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
310
num Events
2
group Id
EG001
num Affected
2
num At Risk
308
num Events
2
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Cardiac valve disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Cardiopulmonary arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
2
num At Risk
308
num Events
2
term
Palpitations

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
310
num Events
9
group Id
EG001
num Affected
6
num At Risk
308
num Events
6
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
3
num At Risk
308
num Events
3
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
2
num At Risk
308
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
310
num Events
3
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
310
num Events
1
group Id
EG001
num Affected
0
num At Risk
308
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
2
num At Risk
308
num Events
5
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
5
num At Risk
310
num Events
5
group Id
EG001
num Affected
2
num At Risk
308
num Events
2
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Sick sinus syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
310
num Events
0
group Id
EG001
num Affected
1
num At Risk
308
num Events
1
term
Sinus tachycardia

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