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NCT02013167 · ADVERSE EVENTS

Adverse events

Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) · Source last updated 2024-03-05

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
From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.
Other-event reporting threshold
5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Standard of Care Chemotherapy

Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive SOC therapy for an additional 12 months.

49 / 109105 / 109Not reported / Not reported
Blinatumomab

Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.

165 / 267250 / 267Not reported / Not reported

Group identifiers: EG000: Standard of Care Chemotherapy · EG001: Blinatumomab

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
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      267
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      267
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      267
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      267
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      267
    term
    Histiocytosis haematophagic
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      267
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      267
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      267
    term
    Lymphadenopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      267
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      267
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      267
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      267
    term
    Acute myocardial infarction

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
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      267
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      267
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      267
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      267
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      267
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      267
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      267
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      267
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      267
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      267
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      267
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      267
    term
    Nausea
Complete source fields
description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
event Groups
  1. description
    Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive SOC therapy for an additional 12 months.
    id
    EG000
    other Num Affected
    105
    other Num At Risk
    109
    serious Num Affected
    49
    serious Num At Risk
    109
    title
    Standard of Care Chemotherapy
  2. description
    Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.
    id
    EG001
    other Num Affected
    250
    other Num At Risk
    267
    serious Num Affected
    165
    serious Num At Risk
    267
    title
    Blinatumomab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      267
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      267
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      267
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      267
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      267
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      267
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      267
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      267
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      267
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      267
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      267
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      267
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      267
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      267
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      267
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      267
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      267
    term
    Histiocytosis haematophagic
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      267
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      267
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      267
    term
    Lymphadenopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      267
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      267
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      267
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      109
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      267
    term
    Acute myocardial infarction
time Frame
From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.

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