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NCT00109707 · ADVERSE EVENTS

Adverse events

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies · Source last updated 2021-06-29

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
From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)
Other-event reporting threshold
5%

Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CML-CP With Prior Imatinib Only

Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

146 / 321319 / 32113 / 321
CML-AP With Prior Imatinib Only

Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

55 / 137136 / 13714 / 137
CML-CP

Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

21 / 4948 / 490 / 49

Group identifiers: EG000: CML-CP With Prior Imatinib Only · EG001: CML-AP With Prior Imatinib Only · EG002: CML-CP

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
      11
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Coronary artery disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    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
      107
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      49
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      49
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      49
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Thrombocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Conjunctivitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      49
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      49
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      49
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      49
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      49
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      49
    term
    Abdominal pain upper
Complete source fields
description
Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.
event Groups
  1. deaths Num Affected
    13
    deaths Num At Risk
    321
    description
    Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    EG000
    other Num Affected
    319
    other Num At Risk
    321
    serious Num Affected
    146
    serious Num At Risk
    321
    title
    CML-CP With Prior Imatinib Only
  2. deaths Num Affected
    14
    deaths Num At Risk
    137
    description
    Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    EG001
    other Num Affected
    136
    other Num At Risk
    137
    serious Num Affected
    55
    serious Num At Risk
    137
    title
    CML-AP With Prior Imatinib Only
  3. deaths Num Affected
    0
    deaths Num At Risk
    49
    description
    Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    EG002
    other Num Affected
    48
    other Num At Risk
    49
    serious Num Affected
    21
    serious Num At Risk
    49
    title
    CML-CP
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      49
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      49
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      49
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Thrombocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Conjunctivitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      49
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      49
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      49
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      49
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      49
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      49
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Coronary artery disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
    term
    Cardiac failure congestive
time Frame
From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)

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