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NCT01371981 · ADVERSE EVENTS

Adverse events

Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2026-06-02

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
While patients were on protocol therapy (including up to 4 courses, stem cell transplant course, and 3 courses of maintenance therapy)) or up to 7 years in follow-up.
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A

INDUCTION (IND) 1Pts receive intrathecal (IT) cytarabine on day 1 and ADE with IV cytarabine over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes days1, 3, 5; etoposide IV 1-2 hours days1-5. IND IILow risk (LR) pts receive cytarabine IT and ADE chemotherapy as in INDI. High risk (HR) cytarabine IT day 1, MA chemo comprising high-dose cytarabine IV over 1-3 hours days1-4, mitoxantrone IV over 15-30 minutes days 3-6. INTENSIFICATION (INT) I: cytarabine IT day 1, AE chemo with high-dose cytarabine IV over 1-3 hours, etoposide IV over 1-2 hours days 1-5. INT II: LR-cytarabine IT day 1; Induction II MA chemo. HR and no SCT donor - high-dose cytarabine IV over 3 hours days1, 2, 8, 9; asparaginase intramuscularly (IM) days2,9. SCT: : pts receive fludarabine phosphate IV over 30 minutes once daily days -5 to -2, busulfan IV over 2 hours 4 times daily days -5 to -2. Allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis.

82 / 559506 / 559198 / 559
Arm B

IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8. IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8. INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9. SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.

305 / 575529 / 575189 / 575
Arm C (Cohort 1)

IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36. INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28. INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2. Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year.

6 / 1212 / 127 / 12
Arm C (Cohort 2)

IND I: Pts receive cytarabine IT \& ADE as in Arm A, IND I \& sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I \& concurrently with chemo). IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36. INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28. INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2. Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year.

16 / 3332 / 3311 / 33
Arm C (Cohort 3)

IND I: Pts receive cytarabine IT \& ADE as in Arm A, IND I \& sorafenib tosylate PO days 11-28. IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36. INT I: Pts receive cytarabine IT \& AE cin Arm A, INT II, \& sorafenib tosylate PO daily days 6-28. INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), \& sorafenib tosylate PO days 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2. Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year.

30 / 4741 / 4716 / 47
Arm D

INDUCTION I: Patients with unknown FLT3/ITD status prior to study enrollment receive cytarabine IT and ADE chemotherapy as in Arm A, Induction I. If patients are determined to be HR FLT3/ITD+ no later than the end of Induction I they will be eligible to participate in Arm C.

2 / 3767 / 3762 / 376

Group identifiers: EG000: Arm A · EG001: Arm B · EG002: Arm C (Cohort 1) · EG003: Arm C (Cohort 2) · EG004: Arm C (Cohort 3) · EG005: Arm D

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Hemolysis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Hemolytic uremic syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Leukocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Asystole
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Atrial flutter
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Cardiac arrest

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      212
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      175
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      376
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Lymph node pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Thrombotic thrombocytopenic purpura
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Asystole
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Cardiac disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Chest pain - cardiac
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    198
    deaths Num At Risk
    559
    description
    INDUCTION (IND) 1Pts receive intrathecal (IT) cytarabine on day 1 and ADE with IV cytarabine over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes days1, 3, 5; etoposide IV 1-2 hours days1-5. IND IILow risk (LR) pts receive cytarabine IT and ADE chemotherapy as in INDI. High risk (HR) cytarabine IT day 1, MA chemo comprising high-dose cytarabine IV over 1-3 hours days1-4, mitoxantrone IV over 15-30 minutes days 3-6. INTENSIFICATION (INT) I: cytarabine IT day 1, AE chemo with high-dose cytarabine IV over 1-3 hours, etoposide IV over 1-2 hours days 1-5. INT II: LR-cytarabine IT day 1; Induction II MA chemo. HR and no SCT donor - high-dose cytarabine IV over 3 hours days1, 2, 8, 9; asparaginase intramuscularly (IM) days2,9. SCT: : pts receive fludarabine phosphate IV over 30 minutes once daily days -5 to -2, busulfan IV over 2 hours 4 times daily days -5 to -2. Allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis.
    id
    EG000
    other Num Affected
    506
    other Num At Risk
    559
    serious Num Affected
    82
    serious Num At Risk
    559
    title
    Arm A
  2. deaths Num Affected
    189
    deaths Num At Risk
    575
    description
    IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8. IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8. INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9. SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.
    id
    EG001
    other Num Affected
    529
    other Num At Risk
    575
    serious Num Affected
    305
    serious Num At Risk
    575
    title
    Arm B
  3. deaths Num Affected
    7
    deaths Num At Risk
    12
    description
    IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36. INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28. INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2. Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year.
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    6
    serious Num At Risk
    12
    title
    Arm C (Cohort 1)
  4. deaths Num Affected
    11
    deaths Num At Risk
    33
    description
    IND I: Pts receive cytarabine IT \& ADE as in Arm A, IND I \& sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I \& concurrently with chemo). IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36. INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28. INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2. Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year.
    id
    EG003
    other Num Affected
    32
    other Num At Risk
    33
    serious Num Affected
    16
    serious Num At Risk
    33
    title
    Arm C (Cohort 2)
  5. deaths Num Affected
    16
    deaths Num At Risk
    47
    description
    IND I: Pts receive cytarabine IT \& ADE as in Arm A, IND I \& sorafenib tosylate PO days 11-28. IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36. INT I: Pts receive cytarabine IT \& AE cin Arm A, INT II, \& sorafenib tosylate PO daily days 6-28. INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), \& sorafenib tosylate PO days 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2. Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year.
    id
    EG004
    other Num Affected
    41
    other Num At Risk
    47
    serious Num Affected
    30
    serious Num At Risk
    47
    title
    Arm C (Cohort 3)
  6. deaths Num Affected
    2
    deaths Num At Risk
    376
    description
    INDUCTION I: Patients with unknown FLT3/ITD status prior to study enrollment receive cytarabine IT and ADE chemotherapy as in Arm A, Induction I. If patients are determined to be HR FLT3/ITD+ no later than the end of Induction I they will be eligible to participate in Arm C.
    id
    EG005
    other Num Affected
    7
    other Num At Risk
    376
    serious Num Affected
    2
    serious Num At Risk
    376
    title
    Arm D
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      212
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      175
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      376
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Lymph node pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Thrombotic thrombocytopenic purpura
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Asystole
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Cardiac disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers not subm
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Chest pain - cardiac
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Hemolysis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Hemolytic uremic syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Leukocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Asystole
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Atrial flutter
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adeers submitted
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      559
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      575
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      376
    term
    Cardiac arrest
time Frame
While patients were on protocol therapy (including up to 4 courses, stem cell transplant course, and 3 courses of maintenance therapy)) or up to 7 years in follow-up.

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Preserved source evidence · Not medical advice