NCT01478048 · ADVERSE EVENTS

Adverse events

Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma · Source last updated 2018-05-21

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 first dose to last dose plus 60 days (assessed up to April 2017, approximately 63 months)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Elotuzumab + Bortezomib + Dexamethasone Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation	39 / 75	72 / 75	37 / 75
Bortezomib + Dexamethasone Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug	31 / 75	71 / 75	39 / 75

Group identifiers: EG000: Elotuzumab + Bortezomib + Dexamethasone · EG001: Bortezomib + Dexamethasone

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 20.0
stats
group Id
EG000
num Affected
1
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
2
num At Risk
75
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Abdominal pain

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 20.0
stats
group Id
EG000
num Affected
25
num At Risk
75
group Id
EG001
num Affected
20
num At Risk
75
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
5
num At Risk
75
group Id
EG001
num Affected
3
num At Risk
75
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
4
num At Risk
75
group Id
EG001
num Affected
7
num At Risk
75
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
13
num At Risk
75
group Id
EG001
num Affected
22
num At Risk
75
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
75
group Id
EG001
num Affected
4
num At Risk
75
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
75
group Id
EG001
num Affected
4
num At Risk
75
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
4
num At Risk
75
group Id
EG001
num Affected
5
num At Risk
75
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
9
num At Risk
75
group Id
EG001
num Affected
2
num At Risk
75
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
8
num At Risk
75
group Id
EG001
num Affected
8
num At Risk
75
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
75
group Id
EG001
num Affected
6
num At Risk
75
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
28
num At Risk
75
group Id
EG001
num Affected
21
num At Risk
75
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
31
num At Risk
75
group Id
EG001
num Affected
24
num At Risk
75
term
Diarrhoea

Complete source fields

event Groups

deaths Num Affected
37
deaths Num At Risk
75
description
Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation
id
EG000
other Num Affected
72
other Num At Risk
75
serious Num Affected
39
serious Num At Risk
75
title
Elotuzumab + Bortezomib + Dexamethasone
deaths Num Affected
39
deaths Num At Risk
75
description
Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
id
EG001
other Num Affected
71
other Num At Risk
75
serious Num Affected
31
serious Num At Risk
75
title
Bortezomib + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
25
num At Risk
75
group Id
EG001
num Affected
20
num At Risk
75
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
5
num At Risk
75
group Id
EG001
num Affected
3
num At Risk
75
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
4
num At Risk
75
group Id
EG001
num Affected
7
num At Risk
75
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
13
num At Risk
75
group Id
EG001
num Affected
22
num At Risk
75
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
75
group Id
EG001
num Affected
4
num At Risk
75
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
75
group Id
EG001
num Affected
4
num At Risk
75
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
4
num At Risk
75
group Id
EG001
num Affected
5
num At Risk
75
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
9
num At Risk
75
group Id
EG001
num Affected
2
num At Risk
75
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
8
num At Risk
75
group Id
EG001
num Affected
8
num At Risk
75
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
75
group Id
EG001
num Affected
6
num At Risk
75
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
28
num At Risk
75
group Id
EG001
num Affected
21
num At Risk
75
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
31
num At Risk
75
group Id
EG001
num Affected
24
num At Risk
75
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
2
num At Risk
75
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
75
group Id
EG001
num Affected
0
num At Risk
75
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
75
group Id
EG001
num Affected
1
num At Risk
75
term
Abdominal pain

time Frame

From first dose to last dose plus 60 days (assessed up to April 2017, approximately 63 months)

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Preserved source evidence · Not medical advice