NCT04752163 · ADVERSE EVENTS

Adverse events

DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia · Source last updated 2025-05-23

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 the date of failure or death from any cause, approximately 3 years 7 months.
Other-event reporting threshold: 5%

Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I (DS-1594b) Cohort 1 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	4 / 4	4 / 4	2 / 4
Phase I (DS-1594b) Cohort 2 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	4 / 4	4 / 4	3 / 4
Phase I (DS-1594b) Cohort 3 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	5 / 5	5 / 5	2 / 5
Phase I (DS-1594b) Cohort 4 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	3 / 3	3 / 3	0 / 3
Phase I (DS-1594b) Cohort 5 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	1 / 1	1 / 1	0 / 1
Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	0 / 0	0 / 0	0 / 0
Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	0 / 0	0 / 0	0 / 0
Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Phase I (DS-1594b) Cohort 1 · EG001: Phase I (DS-1594b) Cohort 2 · EG002: Phase I (DS-1594b) Cohort 3 · EG003: Phase I (DS-1594b) Cohort 4 · EG004: Phase I (DS-1594b) Cohort 5 · EG005: Phase 2 Cohort A and B (DS-1594b) · EG006: Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) · EG007: Phase 2 Cohort D (DS-1594b, Mini-HCVD)

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
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Bacteremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Cytomegalovirus infection reactivation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Enterocolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Eye disorders - Other, specify

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
5
num Events
3
group Id
EG003
num Affected
3
num At Risk
3
num Events
6
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
5
num Events
3
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
5
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Arthritis

Complete source fields

description

Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

event Groups

deaths Num Affected
2
deaths Num At Risk
4
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Phase I (DS-1594b) Cohort 1
deaths Num Affected
3
deaths Num At Risk
4
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Phase I (DS-1594b) Cohort 2
deaths Num Affected
2
deaths Num At Risk
5
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO
id
EG002
other Num Affected
5
other Num At Risk
5
serious Num Affected
5
serious Num At Risk
5
title
Phase I (DS-1594b) Cohort 3
deaths Num Affected
0
deaths Num At Risk
3
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Phase I (DS-1594b) Cohort 4
deaths Num Affected
0
deaths Num At Risk
1
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO
id
EG004
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Phase I (DS-1594b) Cohort 5
deaths Num Affected
0
deaths Num At Risk
0
description
Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO
id
EG005
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Phase 2 Cohort A and B (DS-1594b)
deaths Num Affected
0
deaths Num At Risk
0
description
Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO
id
EG006
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)
deaths Num Affected
0
deaths Num At Risk
0
description
Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
id
EG007
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Phase 2 Cohort D (DS-1594b, Mini-HCVD)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
5
num Events
3
group Id
EG003
num Affected
3
num At Risk
3
num Events
6
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
5
num Events
3
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
5
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Arthritis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Bacteremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
1
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Cytomegalovirus infection reactivation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
5
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Enterocolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
1
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
group Id
EG007
num Affected
0
num At Risk
0
num Events
0
term
Eye disorders - Other, specify

time Frame

Up to the date of failure or death from any cause, approximately 3 years 7 months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice