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NCT01696084 · ADVERSE EVENTS

Adverse events

Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia · Source last updated 2020-08-10

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
Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Other-event reporting threshold
5%

Safety Population: All randomized participants who received at least one dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (CPX-351)

Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.

90 / 153152 / 1531 / 153
Arm B (7+3)

Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.

65 / 151151 / 1510 / 151

Group identifiers: EG000: Arm A (CPX-351) · EG001: Arm B (7+3)

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
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      151
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      151
    term
    Atrial Fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      151
    term
    Cardiac Failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      151
    term
    Left Ventricular Dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
    term
    Myocardial Infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Cardiac Arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Cardiac Failure Congestive

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
    stats
    1. group Id
      EG000
      num Affected
      104
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      151
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      151
    term
    Atrial Fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      151
    term
    Conjunctival Haemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      151
    term
    Vision Blurred
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      103
      num At Risk
      151
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      151
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      151
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      151
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      151
    term
    Abdominal Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      151
    term
    Abdominal Distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      151
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      151
    term
    Stomatitis
Complete source fields
description
Safety Population: All randomized participants who received at least one dose of study treatment.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    153
    description
    Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
    id
    EG000
    other Num Affected
    152
    other Num At Risk
    153
    serious Num Affected
    90
    serious Num At Risk
    153
    title
    Arm A (CPX-351)
  2. deaths Num Affected
    0
    deaths Num At Risk
    151
    description
    Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
    id
    EG001
    other Num Affected
    151
    other Num At Risk
    151
    serious Num Affected
    65
    serious Num At Risk
    151
    title
    Arm B (7+3)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      104
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      151
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      151
    term
    Atrial Fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      151
    term
    Conjunctival Haemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      151
    term
    Vision Blurred
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      103
      num At Risk
      151
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      151
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      151
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      151
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      151
    term
    Abdominal Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      151
    term
    Abdominal Distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      151
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      151
    term
    Stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      151
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      151
    term
    Atrial Fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      151
    term
    Cardiac Failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      151
    term
    Left Ventricular Dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      151
    term
    Myocardial Infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Cardiac Arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      151
    term
    Cardiac Failure Congestive
time Frame
Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.

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