Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00261846 · ADVERSE EVENTS

Adverse events

Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias · Source last updated 2017-07-27

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 (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
Other-event reporting threshold
5%

An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

81 / 195194 / 195Not reported / Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

34 / 8989 / 89Not reported / Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.

1 / 55 / 5Not reported / Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.

15 / 3838 / 38Not reported / Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.

19 / 5050 / 50Not reported / Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.

5 / 2626 / 26Not reported / Not reported
AP-CML Total (Part 2)

All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.

43 / 7979 / 79Not reported / Not reported
BP-CML Total (Part 2)

All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.

37 / 6462 / 64Not reported / Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL

17 / 2423 / 24Not reported / Not reported

Group identifiers: EG000: Bosutinib 500 mg, CP2L-CML IM-R (Part 2) · EG001: Bosutinib 500 mg, CP2L-CML IM-I (Part 2) · EG002: Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) · EG003: Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) · EG004: Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) · EG005: Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) · EG006: AP-CML Total (Part 2) · EG007: BP-CML Total (Part 2) · EG008: Bosutinib 500 mg, Ph+ ALL (Part 2)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      24
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      24
    term
    Leukocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Granulocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Leukopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Pancytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Splenomegaly
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Atrial fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Acute myocardial infarction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Cardiac failure

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      18
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      35
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      24
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      33
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      24
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      12
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      16
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      24
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      24
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      24
    term
    Leukocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      166
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      22
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      67
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      41
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      15
      num At Risk
      24
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      36
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      30
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      12
      num At Risk
      24
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      35
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      26
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      11
      num At Risk
      24
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      19
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      11
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      24
    term
    Abdominal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Abdominal pain upper
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      14
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      24
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Dyspepsia
Complete source fields
description
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
event Groups
  1. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    EG000
    other Num Affected
    194
    other Num At Risk
    195
    serious Num Affected
    81
    serious Num At Risk
    195
    title
    Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
  2. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    EG001
    other Num Affected
    89
    other Num At Risk
    89
    serious Num Affected
    34
    serious Num At Risk
    89
    title
    Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
  3. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
  4. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
    id
    EG003
    other Num Affected
    38
    other Num At Risk
    38
    serious Num Affected
    15
    serious Num At Risk
    38
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
  5. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
    id
    EG004
    other Num Affected
    50
    other Num At Risk
    50
    serious Num Affected
    19
    serious Num At Risk
    50
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
  6. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
    id
    EG005
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    5
    serious Num At Risk
    26
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
  7. description
    All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
    id
    EG006
    other Num Affected
    79
    other Num At Risk
    79
    serious Num Affected
    43
    serious Num At Risk
    79
    title
    AP-CML Total (Part 2)
  8. description
    All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
    id
    EG007
    other Num Affected
    62
    other Num At Risk
    64
    serious Num Affected
    37
    serious Num At Risk
    64
    title
    BP-CML Total (Part 2)
  9. description
    Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
    id
    EG008
    other Num Affected
    23
    other Num At Risk
    24
    serious Num Affected
    17
    serious Num At Risk
    24
    title
    Bosutinib 500 mg, Ph+ ALL (Part 2)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      18
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      35
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      24
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      33
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      24
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      12
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      16
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      24
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      24
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      24
    term
    Leukocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      166
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      22
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      67
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      41
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      15
      num At Risk
      24
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      36
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      30
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      12
      num At Risk
      24
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      35
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      26
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      11
      num At Risk
      24
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      19
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      11
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      24
    term
    Abdominal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Abdominal pain upper
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      14
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      24
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Dyspepsia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      24
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      24
    term
    Leukocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Granulocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Leukopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      24
    term
    Pancytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Splenomegaly
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Atrial fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Acute myocardial infarction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      195
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      50
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      79
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      24
    term
    Cardiac failure
time Frame
Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice