NCT02303821 · ADVERSE EVENTS

Adverse events

Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia · Source last updated 2025-06-04

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: Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks
Other-event reporting threshold: 5%

Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1b: Dose Escalation 1 (20 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	4 / 5	5 / 5	0 / 5
Phase 1b: Dose Escalation 1 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	4 / 6	6 / 6	2 / 6
Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	3 / 3	3 / 3	0 / 3
Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	6 / 7	7 / 7	0 / 7
Phase 1b: Dose Escalation 2 (20/45 mg/m^2 Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	4 / 4	4 / 4	0 / 4
Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	7 / 10	9 / 10	3 / 10
Phase 2: B-cell (20/56 mg/m^2) Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.	44 / 61	61 / 61	41 / 62
Phase 2: T-cell (20/56 mg/m^2) Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.	31 / 44	43 / 44	29 / 44

Group identifiers: EG000: Phase 1b: Dose Escalation 1 (20 mg/m^2) · EG001: Phase 1b: Dose Escalation 1 (20/27 mg/m^2) · EG002: Phase 1b: Dose Escalation 2 (20/27 mg/m^2) · EG003: Phase 1b: Dose Escalation 2 (20/36 mg/m^2) · EG004: Phase 1b: Dose Escalation 2 (20/45 mg/m^2 · EG005: Phase 1b: Dose Escalation 2 (20/56 mg/m^2) · EG006: Phase 2: B-cell (20/56 mg/m^2) · EG007: Phase 2: T-cell (20/56 mg/m^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 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
3
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
8
num At Risk
61
group Id
EG007
num Affected
3
num At Risk
44
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Hyperleukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
3
num At Risk
44
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
2
num At Risk
61
group Id
EG007
num Affected
4
num At Risk
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Cardiac dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Toxic cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
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 23.1/27.0
stats
group Id
EG000
num Affected
4
num At Risk
5
group Id
EG001
num Affected
5
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
4
num At Risk
7
group Id
EG004
num Affected
3
num At Risk
4
group Id
EG005
num Affected
3
num At Risk
10
group Id
EG006
num Affected
37
num At Risk
61
group Id
EG007
num Affected
23
num At Risk
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
3
num At Risk
10
group Id
EG006
num Affected
17
num At Risk
61
group Id
EG007
num Affected
11
num At Risk
44
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
12
num At Risk
61
group Id
EG007
num Affected
10
num At Risk
44
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
6
num At Risk
61
group Id
EG007
num Affected
4
num At Risk
44
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
2
num At Risk
5
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
24
num At Risk
61
group Id
EG007
num Affected
17
num At Risk
44
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
2
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
23
num At Risk
61
group Id
EG007
num Affected
20
num At Risk
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
3
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
4
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
9
num At Risk
61
group Id
EG007
num Affected
7
num At Risk
44
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
3
num At Risk
61
group Id
EG007
num Affected
4
num At Risk
44
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
2
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
7
num At Risk
61
group Id
EG007
num Affected
9
num At Risk
44
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
3
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
4
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
3
num At Risk
10
group Id
EG006
num Affected
13
num At Risk
61
group Id
EG007
num Affected
9
num At Risk
44
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
4
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
5
num At Risk
7
group Id
EG004
num Affected
2
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
8
num At Risk
61
group Id
EG007
num Affected
11
num At Risk
44
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
5
description
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
4
serious Num At Risk
5
title
Phase 1b: Dose Escalation 1 (20 mg/m^2)
deaths Num Affected
2
deaths Num At Risk
6
description
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
deaths Num Affected
0
deaths Num At Risk
7
description
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
id
EG003
other Num Affected
7
other Num At Risk
7
serious Num Affected
6
serious Num At Risk
7
title
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
deaths Num Affected
0
deaths Num At Risk
4
description
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
id
EG004
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Phase 1b: Dose Escalation 2 (20/45 mg/m^2
deaths Num Affected
3
deaths Num At Risk
10
description
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
id
EG005
other Num Affected
9
other Num At Risk
10
serious Num Affected
7
serious Num At Risk
10
title
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
deaths Num Affected
41
deaths Num At Risk
62
description
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
id
EG006
other Num Affected
61
other Num At Risk
61
serious Num Affected
44
serious Num At Risk
61
title
Phase 2: B-cell (20/56 mg/m^2)
deaths Num Affected
29
deaths Num At Risk
44
description
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
id
EG007
other Num Affected
43
other Num At Risk
44
serious Num Affected
31
serious Num At Risk
44
title
Phase 2: T-cell (20/56 mg/m^2)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
4
num At Risk
5
group Id
EG001
num Affected
5
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
4
num At Risk
7
group Id
EG004
num Affected
3
num At Risk
4
group Id
EG005
num Affected
3
num At Risk
10
group Id
EG006
num Affected
37
num At Risk
61
group Id
EG007
num Affected
23
num At Risk
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
3
num At Risk
10
group Id
EG006
num Affected
17
num At Risk
61
group Id
EG007
num Affected
11
num At Risk
44
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
12
num At Risk
61
group Id
EG007
num Affected
10
num At Risk
44
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
6
num At Risk
61
group Id
EG007
num Affected
4
num At Risk
44
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
2
num At Risk
5
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
24
num At Risk
61
group Id
EG007
num Affected
17
num At Risk
44
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
2
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
23
num At Risk
61
group Id
EG007
num Affected
20
num At Risk
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
3
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
4
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
9
num At Risk
61
group Id
EG007
num Affected
7
num At Risk
44
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
3
num At Risk
61
group Id
EG007
num Affected
4
num At Risk
44
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
2
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
7
num At Risk
61
group Id
EG007
num Affected
9
num At Risk
44
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
3
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
4
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
3
num At Risk
10
group Id
EG006
num Affected
13
num At Risk
61
group Id
EG007
num Affected
9
num At Risk
44
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
4
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
5
num At Risk
7
group Id
EG004
num Affected
2
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
8
num At Risk
61
group Id
EG007
num Affected
11
num At Risk
44
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
3
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
8
num At Risk
61
group Id
EG007
num Affected
3
num At Risk
44
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Hyperleukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
3
num At Risk
44
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
2
num At Risk
61
group Id
EG007
num Affected
4
num At Risk
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
61
group Id
EG007
num Affected
1
num At Risk
44
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Cardiac dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Toxic cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1/27.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
61
group Id
EG007
num Affected
0
num At Risk
44
term
Abdominal pain

time Frame

Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks

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Preserved source evidence · Not medical advice