NCT02336815 · ADVERSE EVENTS

Adverse events

Selinexor Treatment of Refractory Myeloma · Source last updated 2023-01-26

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: Baseline to 30 days after last dose of study treatment (maximum duration of 18 months)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1 Participants with quad-exposed, double-class-refractory (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, but not an anti-CD38 mab) and penta-exposed, triple-class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, two dosing schedules (1) Selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly on Days 1 and 3 for 3 weeks of each 4-week cycle (2) Selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly continuously in 4-week cycles; until disease progression, death, or unacceptable toxicity (maximum duration of approximately 13 months).	45 / 79	79 / 79	20 / 79
Part 2 Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, Selinexor 80 mg post oral (PO) plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).	78 / 123	123 / 123	28 / 123

Group identifiers: EG000: Part 1 · EG001: Part 2

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 (20.1)
stats
group Id
EG000
num Affected
5
num At Risk
79
num Events
5
group Id
EG001
num Affected
3
num At Risk
123
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
79
num Events
2
group Id
EG001
num Affected
4
num At Risk
123
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
3
num At Risk
79
num Events
3
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
79
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
79
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
79
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
79
num Events
2
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
79
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
79
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
79
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
3
num At Risk
79
num Events
3
group Id
EG001
num Affected
2
num At Risk
123
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
79
num Events
2
group Id
EG001
num Affected
2
num At Risk
123
num Events
2
term
Diarrhoea

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 (20.1)
stats
group Id
EG000
num Affected
58
num At Risk
79
num Events
58
group Id
EG001
num Affected
91
num At Risk
123
num Events
91
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
37
num At Risk
79
num Events
37
group Id
EG001
num Affected
80
num At Risk
123
num Events
80
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
23
num At Risk
79
num Events
23
group Id
EG001
num Affected
49
num At Risk
123
num Events
49
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
20
num At Risk
79
num Events
20
group Id
EG001
num Affected
41
num At Risk
123
num Events
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
11
num At Risk
79
num Events
11
group Id
EG001
num Affected
20
num At Risk
123
num Events
20
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
9
num At Risk
79
num Events
9
group Id
EG001
num Affected
4
num At Risk
123
num Events
4
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
10
num At Risk
79
num Events
10
group Id
EG001
num Affected
13
num At Risk
123
num Events
13
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
60
num At Risk
79
num Events
60
group Id
EG001
num Affected
88
num At Risk
123
num Events
88
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
35
num At Risk
79
num Events
35
group Id
EG001
num Affected
57
num At Risk
123
num Events
57
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
37
num At Risk
79
num Events
37
group Id
EG001
num Affected
47
num At Risk
123
num Events
47
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
21
num At Risk
79
num Events
21
group Id
EG001
num Affected
27
num At Risk
123
num Events
27
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
7
num At Risk
79
num Events
7
group Id
EG001
num Affected
12
num At Risk
123
num Events
12
term
Abdominal pain

Complete source fields

event Groups

deaths Num Affected
20
deaths Num At Risk
79
description
Participants with quad-exposed, double-class-refractory (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, but not an anti-CD38 mab) and penta-exposed, triple-class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, two dosing schedules (1) Selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly on Days 1 and 3 for 3 weeks of each 4-week cycle (2) Selinexor 80 mg plus low-dose dexamethasone 20 mg (Sd) twice-weekly continuously in 4-week cycles; until disease progression, death, or unacceptable toxicity (maximum duration of approximately 13 months).
id
EG000
other Num Affected
79
other Num At Risk
79
serious Num Affected
45
serious Num At Risk
79
title
Part 1
deaths Num Affected
28
deaths Num At Risk
123
description
Participants who previously had received more than 3 anti-MM regimens and had penta-exposed, triple class-refractory MM (i.e. previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab, and refractory to prior treatment with glucocorticoids, an IMiD, a PI, and the anti-CD38 mAb daratumumab) received, Selinexor 80 mg post oral (PO) plus low-dose dexamethasone 20 mg Sd twice-weekly on Days 1 and 3 until disease progression, death, or unacceptable toxicity (maximum duration of approximately 17 months).
id
EG001
other Num Affected
123
other Num At Risk
123
serious Num Affected
78
serious Num At Risk
123
title
Part 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
58
num At Risk
79
num Events
58
group Id
EG001
num Affected
91
num At Risk
123
num Events
91
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
37
num At Risk
79
num Events
37
group Id
EG001
num Affected
80
num At Risk
123
num Events
80
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
23
num At Risk
79
num Events
23
group Id
EG001
num Affected
49
num At Risk
123
num Events
49
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
20
num At Risk
79
num Events
20
group Id
EG001
num Affected
41
num At Risk
123
num Events
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
11
num At Risk
79
num Events
11
group Id
EG001
num Affected
20
num At Risk
123
num Events
20
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
9
num At Risk
79
num Events
9
group Id
EG001
num Affected
4
num At Risk
123
num Events
4
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
10
num At Risk
79
num Events
10
group Id
EG001
num Affected
13
num At Risk
123
num Events
13
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
60
num At Risk
79
num Events
60
group Id
EG001
num Affected
88
num At Risk
123
num Events
88
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
35
num At Risk
79
num Events
35
group Id
EG001
num Affected
57
num At Risk
123
num Events
57
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
37
num At Risk
79
num Events
37
group Id
EG001
num Affected
47
num At Risk
123
num Events
47
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
21
num At Risk
79
num Events
21
group Id
EG001
num Affected
27
num At Risk
123
num Events
27
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
7
num At Risk
79
num Events
7
group Id
EG001
num Affected
12
num At Risk
123
num Events
12
term
Abdominal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
5
num At Risk
79
num Events
5
group Id
EG001
num Affected
3
num At Risk
123
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
79
num Events
2
group Id
EG001
num Affected
4
num At Risk
123
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
3
num At Risk
79
num Events
3
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
79
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
79
num Events
1
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
79
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
79
num Events
2
group Id
EG001
num Affected
0
num At Risk
123
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
79
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
79
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
79
num Events
0
group Id
EG001
num Affected
1
num At Risk
123
num Events
1
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
3
num At Risk
79
num Events
3
group Id
EG001
num Affected
2
num At Risk
123
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
79
num Events
2
group Id
EG001
num Affected
2
num At Risk
123
num Events
2
term
Diarrhoea

time Frame

Baseline to 30 days after last dose of study treatment (maximum duration of 18 months)

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