NCT02757326 · ADVERSE EVENTS

Adverse events

ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma · Source last updated 2021-06-18

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: Up to 20.5 weeks
Other-event reporting threshold: 0%

Treatment emergent adverse events (TEAE) were any event not present before exposure to study medication or any event already present that worsens in either intensity or frequency following exposure to study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
250 mg Phase 1b For Phase 1b, ABC294640 was dosed at 250 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.	1 / 3	3 / 3	0 / 3
500 mg Phase 1b For Phase 1b, ABC294640 was dosed at 500 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.	3 / 4	4 / 4	0 / 4
750 mg Phase 1b For Phase 1b, ABC294640 was dosed at 750 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.	1 / 6	6 / 6	0 / 6

Group identifiers: EG000: 250 mg Phase 1b · EG001: 500 mg Phase 1b · EG002: 750 mg Phase 1b

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
notes
250 mg cohort, Grade 3, NOT RELATED
organ System
Psychiatric disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
ALTERED MENTAL STATUS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 3, Not related, Drug interrupted
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 2, not related, dose not changed
organ System
Nervous system disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Depressed level of consciousness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Colitis- not related to therapy
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Worsening constipation not related to therapy
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Hip fracture not related to therapy - Grade 3
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hip fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cardiac arrest not related to therapy - Grade 4
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Impending pathological fracture, right femur, not therapy related - Grade 2
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Pathological fracture

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 (10.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
28
group Id
EG001
num Affected
4
num At Risk
4
num Events
34
group Id
EG002
num Affected
6
num At Risk
6
num Events
41
term
Summary of Adverse events occurring in >10% of patients by System Organ Class and Preferred Term
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
3
num At Risk
6
num Events
3
term
Hypokalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
term
Hyponatraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
term
Hypophosphataemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Hypercalcaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
4
num Events
3
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hypoalbuminaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hypomagnesaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hyperglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hyperphosphataemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hyperuricaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Hypocalcaemia

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
For Phase 1b, ABC294640 was dosed at 250 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
250 mg Phase 1b
deaths Num Affected
0
deaths Num At Risk
4
description
For Phase 1b, ABC294640 was dosed at 500 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
500 mg Phase 1b
deaths Num Affected
0
deaths Num At Risk
6
description
For Phase 1b, ABC294640 was dosed at 750 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
750 mg Phase 1b

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
28
group Id
EG001
num Affected
4
num At Risk
4
num Events
34
group Id
EG002
num Affected
6
num At Risk
6
num Events
41
term
Summary of Adverse events occurring in >10% of patients by System Organ Class and Preferred Term
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
3
num At Risk
6
num Events
3
term
Hypokalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
term
Hyponatraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
term
Hypophosphataemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Hypercalcaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
4
num Events
3
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hypoalbuminaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hypomagnesaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hyperglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hyperphosphataemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hyperuricaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Hypocalcaemia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
250 mg cohort, Grade 3, NOT RELATED
organ System
Psychiatric disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
ALTERED MENTAL STATUS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 3, Not related, Drug interrupted
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 2, not related, dose not changed
organ System
Nervous system disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Depressed level of consciousness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Colitis- not related to therapy
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Worsening constipation not related to therapy
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Hip fracture not related to therapy - Grade 3
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Hip fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cardiac arrest not related to therapy - Grade 4
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Impending pathological fracture, right femur, not therapy related - Grade 2
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Pathological fracture

time Frame

Up to 20.5 weeks

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Preserved source evidence · Not medical advice