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NCT01564784 · ADVERSE EVENTS

Adverse events

A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia · Source last updated 2019-01-09

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
SAEs and non-serious AEs are summarized from Cycle 1 Day 1 up to 42 days after last dose, or any time after Cycle 1 Day1 (treatment-related).
Other-event reporting threshold
5%

An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another participant, or 1 participant may have experienced both a serious \& non-serious event. Events were reported up to at least 28 days after last dose.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Inotuzumab Ozogamicin

Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).

85 / 164159 / 164Not reported / Not reported
Defined Investigator's Choice of Chemotherapy

Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.

72 / 143143 / 143Not reported / Not reported

Group identifiers: EG000: Inotuzumab Ozogamicin · EG001: Defined Investigator's Choice of 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 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    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
      19
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      143
    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
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Leukopenia
  4. 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
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    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
      164
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
    term
    Pancytopenia
  6. 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
      164
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Cardiac failure congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Left ventricular dysfunction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    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
      54
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      143
    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
      27
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      143
    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
      47
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      143
    term
    Leukopenia
  4. 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
      164
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      143
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      143
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      143
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      143
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      143
    term
    Dry eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      143
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      143
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      143
    term
    Constipation
Complete source fields
description
An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another participant, or 1 participant may have experienced both a serious \& non-serious event. Events were reported up to at least 28 days after last dose.
event Groups
  1. description
    Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
    id
    EG000
    other Num Affected
    159
    other Num At Risk
    164
    serious Num Affected
    85
    serious Num At Risk
    164
    title
    Inotuzumab Ozogamicin
  2. description
    Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
    id
    EG001
    other Num Affected
    143
    other Num At Risk
    143
    serious Num Affected
    72
    serious Num At Risk
    143
    title
    Defined Investigator's Choice of Chemotherapy
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
      54
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      143
    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
      27
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      143
    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
      47
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      143
    term
    Leukopenia
  4. 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
      164
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      143
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      143
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      143
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      143
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      143
    term
    Dry eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      143
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      143
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      143
    term
    Constipation
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
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    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
      19
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      143
    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
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Leukopenia
  4. 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
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    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
      164
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
    term
    Pancytopenia
  6. 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
      164
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Cardiac failure congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Left ventricular dysfunction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      164
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
    term
    Myocardial infarction
time Frame
SAEs and non-serious AEs are summarized from Cycle 1 Day 1 up to 42 days after last dose, or any time after Cycle 1 Day1 (treatment-related).

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