NCT01602224 · ADVERSE EVENTS

Adverse events

A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM) · Source last updated 2019-10-08

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%

All randomized participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
100 mg Tabalumab+Dexamethasone+Bortezomib Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.	33 / 73	71 / 73	Not reported / Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.	35 / 74	70 / 74	Not reported / Not reported
Placebo Comparator: Placebo + Dexamethasone + Bortezomib Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.	26 / 72	69 / 72	Not reported / Not reported

Group identifiers: EG000: 100 mg Tabalumab+Dexamethasone+Bortezomib · EG001: 300 mg Tabalumab+Dexamethasone+Bortezomib · EG002: Placebo Comparator: Placebo + Dexamethasone + Bortezomib

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 17.0
stats
group Id
EG000
num Affected
2
num At Risk
73
num Events
3
group Id
EG001
num Affected
2
num At Risk
74
num Events
2
group Id
EG002
num Affected
2
num At Risk
72
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
73
num Events
3
group Id
EG001
num Affected
0
num At Risk
74
num Events
0
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
0
num At Risk
74
num Events
0
group Id
EG002
num Affected
1
num At Risk
72
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
73
num Events
3
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
1
num At Risk
72
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
2
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
6
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
2
group Id
EG001
num Affected
1
num At Risk
74
num Events
2
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
2
group Id
EG001
num Affected
0
num At Risk
74
num Events
0
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Ventricular dysfunction

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 17.0
stats
group Id
EG000
num Affected
25
num At Risk
73
num Events
52
group Id
EG001
num Affected
13
num At Risk
74
num Events
25
group Id
EG002
num Affected
17
num At Risk
72
num Events
24
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
6
num At Risk
73
num Events
8
group Id
EG001
num Affected
4
num At Risk
74
num Events
11
group Id
EG002
num Affected
6
num At Risk
72
num Events
6
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
16
num At Risk
73
num Events
34
group Id
EG001
num Affected
8
num At Risk
74
num Events
26
group Id
EG002
num Affected
23
num At Risk
72
num Events
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
4
num At Risk
73
num Events
4
group Id
EG001
num Affected
2
num At Risk
74
num Events
2
group Id
EG002
num Affected
3
num At Risk
72
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
73
num Events
2
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
4
num At Risk
72
num Events
4
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
8
num At Risk
73
num Events
13
group Id
EG001
num Affected
5
num At Risk
74
num Events
5
group Id
EG002
num Affected
5
num At Risk
72
num Events
8
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
5
num At Risk
73
num Events
8
group Id
EG001
num Affected
6
num At Risk
74
num Events
6
group Id
EG002
num Affected
5
num At Risk
72
num Events
6
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
5
num At Risk
73
num Events
5
group Id
EG001
num Affected
4
num At Risk
74
num Events
4
group Id
EG002
num Affected
3
num At Risk
72
num Events
4
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
19
num At Risk
73
num Events
31
group Id
EG001
num Affected
26
num At Risk
74
num Events
32
group Id
EG002
num Affected
23
num At Risk
72
num Events
30
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
28
num At Risk
73
num Events
44
group Id
EG001
num Affected
27
num At Risk
74
num Events
40
group Id
EG002
num Affected
21
num At Risk
72
num Events
27
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
5
num At Risk
73
num Events
5
group Id
EG001
num Affected
7
num At Risk
74
num Events
9
group Id
EG002
num Affected
8
num At Risk
72
num Events
10
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
15
num At Risk
73
num Events
19
group Id
EG001
num Affected
11
num At Risk
74
num Events
12
group Id
EG002
num Affected
14
num At Risk
72
num Events
18
term
Nausea

Complete source fields

description

All randomized participants who received at least 1 dose of study drug.

event Groups

description
Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
id
EG000
other Num Affected
71
other Num At Risk
73
serious Num Affected
33
serious Num At Risk
73
title
100 mg Tabalumab+Dexamethasone+Bortezomib
description
Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
id
EG001
other Num Affected
70
other Num At Risk
74
serious Num Affected
35
serious Num At Risk
74
title
300 mg Tabalumab+Dexamethasone+Bortezomib
description
Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
id
EG002
other Num Affected
69
other Num At Risk
72
serious Num Affected
26
serious Num At Risk
72
title
Placebo Comparator: Placebo + Dexamethasone + Bortezomib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
25
num At Risk
73
num Events
52
group Id
EG001
num Affected
13
num At Risk
74
num Events
25
group Id
EG002
num Affected
17
num At Risk
72
num Events
24
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
6
num At Risk
73
num Events
8
group Id
EG001
num Affected
4
num At Risk
74
num Events
11
group Id
EG002
num Affected
6
num At Risk
72
num Events
6
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
16
num At Risk
73
num Events
34
group Id
EG001
num Affected
8
num At Risk
74
num Events
26
group Id
EG002
num Affected
23
num At Risk
72
num Events
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
4
num At Risk
73
num Events
4
group Id
EG001
num Affected
2
num At Risk
74
num Events
2
group Id
EG002
num Affected
3
num At Risk
72
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
73
num Events
2
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
4
num At Risk
72
num Events
4
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
8
num At Risk
73
num Events
13
group Id
EG001
num Affected
5
num At Risk
74
num Events
5
group Id
EG002
num Affected
5
num At Risk
72
num Events
8
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
5
num At Risk
73
num Events
8
group Id
EG001
num Affected
6
num At Risk
74
num Events
6
group Id
EG002
num Affected
5
num At Risk
72
num Events
6
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
5
num At Risk
73
num Events
5
group Id
EG001
num Affected
4
num At Risk
74
num Events
4
group Id
EG002
num Affected
3
num At Risk
72
num Events
4
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
19
num At Risk
73
num Events
31
group Id
EG001
num Affected
26
num At Risk
74
num Events
32
group Id
EG002
num Affected
23
num At Risk
72
num Events
30
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
28
num At Risk
73
num Events
44
group Id
EG001
num Affected
27
num At Risk
74
num Events
40
group Id
EG002
num Affected
21
num At Risk
72
num Events
27
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
5
num At Risk
73
num Events
5
group Id
EG001
num Affected
7
num At Risk
74
num Events
9
group Id
EG002
num Affected
8
num At Risk
72
num Events
10
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
15
num At Risk
73
num Events
19
group Id
EG001
num Affected
11
num At Risk
74
num Events
12
group Id
EG002
num Affected
14
num At Risk
72
num Events
18
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
73
num Events
3
group Id
EG001
num Affected
2
num At Risk
74
num Events
2
group Id
EG002
num Affected
2
num At Risk
72
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
73
num Events
3
group Id
EG001
num Affected
0
num At Risk
74
num Events
0
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
0
num At Risk
74
num Events
0
group Id
EG002
num Affected
1
num At Risk
72
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
73
num Events
3
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
1
num At Risk
72
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
2
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
1
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
74
num Events
6
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
2
group Id
EG001
num Affected
1
num At Risk
74
num Events
2
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
2
group Id
EG001
num Affected
0
num At Risk
74
num Events
0
group Id
EG002
num Affected
0
num At Risk
72
num Events
0
term
Ventricular dysfunction

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