NCT02739594 · ADVERSE EVENTS

Adverse events

Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma · Source last updated 2016-07-22

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: From Baseline to end of study (up to Week 96)
Other-event reporting threshold: 5%

Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ibandronate Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.	27 / 46	43 / 46	Not reported / Not reported
Zoledronate Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.	18 / 43	34 / 43	Not reported / Not reported

Group identifiers: EG000: Ibandronate · EG001: Zoledronate

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Normochromic normocytic anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
2
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Diverticulum
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Enteritis

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
11
num At Risk
46
group Id
EG001
num Affected
11
num At Risk
43
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
10
num At Risk
46
group Id
EG001
num Affected
7
num At Risk
43
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
6
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
43
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
43
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
10
num At Risk
46
group Id
EG001
num Affected
8
num At Risk
43
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
6
num At Risk
46
group Id
EG001
num Affected
9
num At Risk
43
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
4
num At Risk
46
group Id
EG001
num Affected
4
num At Risk
43
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
4
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
43
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
7
num At Risk
46
group Id
EG001
num Affected
10
num At Risk
43
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
7
num At Risk
46
group Id
EG001
num Affected
7
num At Risk
43
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
6
num At Risk
46
group Id
EG001
num Affected
7
num At Risk
43
term
Pyrexia

Complete source fields

description

Safety Population: All participants who received at least one dose of study medication and completed at least one follow-up assessment visit.

event Groups

description
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
id
EG000
other Num Affected
43
other Num At Risk
46
serious Num Affected
27
serious Num At Risk
46
title
Ibandronate
description
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
id
EG001
other Num Affected
34
other Num At Risk
43
serious Num Affected
18
serious Num At Risk
43
title
Zoledronate

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
11
num At Risk
46
group Id
EG001
num Affected
11
num At Risk
43
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
10
num At Risk
46
group Id
EG001
num Affected
7
num At Risk
43
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
6
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
43
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
43
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
10
num At Risk
46
group Id
EG001
num Affected
8
num At Risk
43
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
6
num At Risk
46
group Id
EG001
num Affected
9
num At Risk
43
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
4
num At Risk
46
group Id
EG001
num Affected
4
num At Risk
43
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
4
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
43
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
7
num At Risk
46
group Id
EG001
num Affected
10
num At Risk
43
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
7
num At Risk
46
group Id
EG001
num Affected
7
num At Risk
43
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
6
num At Risk
46
group Id
EG001
num Affected
7
num At Risk
43
term
Pyrexia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Normochromic normocytic anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
2
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
43
term
Diverticulum
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
43
term
Enteritis

time Frame

From Baseline to end of study (up to Week 96)

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Preserved source evidence · Not medical advice