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NCT00061945 · ADVERSE EVENTS

Adverse events

Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia · Source last updated 2022-05-03

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I - Alemtuzumab and Combination Chemotherapy

See detailed description or participant flow.

60 / 11999 / 119Not reported / Not reported
Phase II - Alemtuzumab and Combination Chemotherapy

See detailed description or participant flow.

98 / 181152 / 181Not reported / Not reported

Group identifiers: EG000: Phase I - Alemtuzumab and Combination Chemotherapy · EG001: Phase II - Alemtuzumab and Combination Chemotherapy

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 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      119
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      181
      num Events
      5
    term
    Disseminated intravascular coagulation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      119
      num Events
      35
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      181
      num Events
      52
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      119
      num Events
      86
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      181
      num Events
      146
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Lymphatic disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      181
      num Events
      0
    term
    Arrhythmia supraventricular
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      181
      num Events
      0
    term
    Asystole
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      119
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      181
      num Events
      6
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Atrial tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      181
      num Events
      2
    term
    Cardiac disorder
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      181
      num Events
      4
    term
    Cardiac pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Cardiac valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Cardiopulmonary 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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      119
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      181
      num Events
      0
    term
    Bone marrow hypocellular
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      119
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      181
      num Events
      11
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      119
      num Events
      74
    2. group Id
      EG001
      num Affected
      93
      num At Risk
      181
      num Events
      141
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      119
      num Events
      352
    2. group Id
      EG001
      num Affected
      150
      num At Risk
      181
      num Events
      650
    term
    Hemoglobin decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      119
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Lymphatic disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Spleen disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      119
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      181
      num Events
      9
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Atrial tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      181
      num Events
      4
    term
    Cardiac disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      119
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      181
      num Events
      6
    term
    Cardiac pain
Complete source fields
event Groups
  1. description
    See detailed description or participant flow.
    id
    EG000
    other Num Affected
    99
    other Num At Risk
    119
    serious Num Affected
    60
    serious Num At Risk
    119
    title
    Phase I - Alemtuzumab and Combination Chemotherapy
  2. description
    See detailed description or participant flow.
    id
    EG001
    other Num Affected
    152
    other Num At Risk
    181
    serious Num Affected
    98
    serious Num At Risk
    181
    title
    Phase II - Alemtuzumab and Combination Chemotherapy
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      119
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      181
      num Events
      0
    term
    Bone marrow hypocellular
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      119
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      181
      num Events
      11
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      119
      num Events
      74
    2. group Id
      EG001
      num Affected
      93
      num At Risk
      181
      num Events
      141
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      119
      num Events
      352
    2. group Id
      EG001
      num Affected
      150
      num At Risk
      181
      num Events
      650
    term
    Hemoglobin decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      119
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Lymphatic disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Spleen disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      119
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      181
      num Events
      9
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Atrial tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      181
      num Events
      4
    term
    Cardiac disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      119
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      181
      num Events
      6
    term
    Cardiac pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      119
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      181
      num Events
      5
    term
    Disseminated intravascular coagulation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      119
      num Events
      35
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      181
      num Events
      52
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      119
      num Events
      86
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      181
      num Events
      146
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Lymphatic disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      181
      num Events
      0
    term
    Arrhythmia supraventricular
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      181
      num Events
      0
    term
    Asystole
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      119
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      181
      num Events
      6
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Atrial tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      181
      num Events
      2
    term
    Cardiac disorder
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      119
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      181
      num Events
      4
    term
    Cardiac pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Cardiac valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      119
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      181
      num Events
      1
    term
    Cardiopulmonary arrest

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