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NCT02101853 · ADVERSE EVENTS

Adverse events

Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia · Source last updated 2026-07-29

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 3 years from start of Block 1 to end of protocol therapy
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
Block 1 Induction Therapy

All relapsed B-ALL patients enrolled on AALL1331 for Block 1 induction therapy.

63 / 661456 / 66124 / 661
Arm A (HR and IR Control)

Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the Block 2.

26 / 10992 / 1099 / 109
Arm B (HR and IR Blinatumomab)

Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the first block of blinatumomab.

45 / 107103 / 1075 / 107
Arm C (LR Control)

Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance. CNS3 patients receive chemoradiation post-Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2.

16 / 129118 / 1293 / 129
Arm D (LR Blinatumomab)

Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance. CNS3 patients receive chemoradiation post Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2.

69 / 127123 / 1270 / 127
Blinatumomab Salvarage Therapy

Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the first block of blinatumomab.

16 / 2726 / 272 / 27

Group identifiers: EG000: Block 1 Induction Therapy · EG001: Arm A (HR and IR Control) · EG002: Arm B (HR and IR Blinatumomab) · EG003: Arm C (LR Control) · EG004: Arm D (LR Blinatumomab) · EG005: Blinatumomab Salvarage Therapy

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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      129
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      127
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      661
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      661
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      109
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
      num Events
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      129
      num Events
      6
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      127
      num Events
      27
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      27
      num Events
      6
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiac disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      661
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      127
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Left ventricular systolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      127
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Supraventricular tachycardia

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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      661
      num Events
      5
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      109
      num Events
      134
    3. group Id
      EG002
      num Affected
      82
      num At Risk
      107
      num Events
      124
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      129
      num Events
      207
    5. group Id
      EG004
      num Affected
      95
      num At Risk
      127
      num Events
      236
    6. group Id
      EG005
      num Affected
      20
      num At Risk
      27
      num Events
      33
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      129
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      127
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      4
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      661
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      191
      num At Risk
      661
      num Events
      204
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      109
      num Events
      71
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      107
      num Events
      2
    4. group Id
      EG003
      num Affected
      78
      num At Risk
      129
      num Events
      165
    5. group Id
      EG004
      num Affected
      63
      num At Risk
      127
      num Events
      126
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      27
      num Events
      7
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Lymph node pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Spleen disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Thrombotic thrombocytopenic purpura
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Aortic valve disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      661
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      129
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      127
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Cardiac disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Chest pain - cardiac
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      127
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Conduction disorder
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
    24
    deaths Num At Risk
    661
    description
    All relapsed B-ALL patients enrolled on AALL1331 for Block 1 induction therapy.
    id
    EG000
    other Num Affected
    456
    other Num At Risk
    661
    serious Num Affected
    63
    serious Num At Risk
    661
    title
    Block 1 Induction Therapy
  2. deaths Num Affected
    9
    deaths Num At Risk
    109
    description
    Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the Block 2.
    id
    EG001
    other Num Affected
    92
    other Num At Risk
    109
    serious Num Affected
    26
    serious Num At Risk
    109
    title
    Arm A (HR and IR Control)
  3. deaths Num Affected
    5
    deaths Num At Risk
    107
    description
    Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the first block of blinatumomab.
    id
    EG002
    other Num Affected
    103
    other Num At Risk
    107
    serious Num Affected
    45
    serious Num At Risk
    107
    title
    Arm B (HR and IR Blinatumomab)
  4. deaths Num Affected
    3
    deaths Num At Risk
    129
    description
    Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance. CNS3 patients receive chemoradiation post-Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2.
    id
    EG003
    other Num Affected
    118
    other Num At Risk
    129
    serious Num Affected
    16
    serious Num At Risk
    129
    title
    Arm C (LR Control)
  5. deaths Num Affected
    0
    deaths Num At Risk
    127
    description
    Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance. CNS3 patients receive chemoradiation post Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2.
    id
    EG004
    other Num Affected
    123
    other Num At Risk
    127
    serious Num Affected
    69
    serious Num At Risk
    127
    title
    Arm D (LR Blinatumomab)
  6. deaths Num Affected
    2
    deaths Num At Risk
    27
    description
    Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the first block of blinatumomab.
    id
    EG005
    other Num Affected
    26
    other Num At Risk
    27
    serious Num Affected
    16
    serious Num At Risk
    27
    title
    Blinatumomab Salvarage Therapy
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      661
      num Events
      5
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      109
      num Events
      134
    3. group Id
      EG002
      num Affected
      82
      num At Risk
      107
      num Events
      124
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      129
      num Events
      207
    5. group Id
      EG004
      num Affected
      95
      num At Risk
      127
      num Events
      236
    6. group Id
      EG005
      num Affected
      20
      num At Risk
      27
      num Events
      33
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      129
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      127
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      4
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      661
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      191
      num At Risk
      661
      num Events
      204
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      109
      num Events
      71
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      107
      num Events
      2
    4. group Id
      EG003
      num Affected
      78
      num At Risk
      129
      num Events
      165
    5. group Id
      EG004
      num Affected
      63
      num At Risk
      127
      num Events
      126
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      27
      num Events
      7
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Lymph node pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Spleen disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Thrombotic thrombocytopenic purpura
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Aortic valve disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      661
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      129
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      127
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Cardiac disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Chest pain - cardiac
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      127
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Conduction disorder
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      129
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      127
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      661
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      661
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      109
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      107
      num Events
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      129
      num Events
      6
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      127
      num Events
      27
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      27
      num Events
      6
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Cardiac disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      661
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      127
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Left ventricular systolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      127
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      661
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      107
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      661
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      107
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      129
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      127
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Supraventricular tachycardia
time Frame
Up to 3 years from start of Block 1 to end of protocol therapy

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice