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NCT00777036 · ADVERSE EVENTS

Adverse events

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib · Source last updated 2025-08-29

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
Participants were assessed for All-Cause Mortality, Serious adverse events (SAEs) and Other adverse events (AEs) in all treated participants (up to approximately 14 years 6 months). The participants who crossed over from Cohort 3 to PK Sub-study are accounted for in both arms. PK Sub-study only for the duration of the PK Sub-study.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1

Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.

16 / 2927 / 291 / 29
Cohort 2: BP-CML Only

Children and adolescents with BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.

7 / 87 / 84 / 8
Cohort 2: Ph + ALL Only

Children and adolescents with Ph+ ALL who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.

6 / 99 / 97 / 9
Cohort 3a

Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.

21 / 5150 / 510 / 51
Cohort 3b

Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.

12 / 3333 / 330 / 33
PK Sub-Study

Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.

0 / 70 / 70 / 7

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2: BP-CML Only · EG002: Cohort 2: Ph + ALL Only · EG003: Cohort 3a · EG004: Cohort 3b · EG005: PK Sub-Study

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Lymphadenopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Left ventricular dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Anal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Colitis

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Haemoglobinaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Lymphadenopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Sinus bradycardia
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    29
    description
    Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    id
    EG000
    other Num Affected
    27
    other Num At Risk
    29
    serious Num Affected
    16
    serious Num At Risk
    29
    title
    Cohort 1
  2. deaths Num Affected
    4
    deaths Num At Risk
    8
    description
    Children and adolescents with BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    7
    serious Num At Risk
    8
    title
    Cohort 2: BP-CML Only
  3. deaths Num Affected
    7
    deaths Num At Risk
    9
    description
    Children and adolescents with Ph+ ALL who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    id
    EG002
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    6
    serious Num At Risk
    9
    title
    Cohort 2: Ph + ALL Only
  4. deaths Num Affected
    0
    deaths Num At Risk
    51
    description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    id
    EG003
    other Num Affected
    50
    other Num At Risk
    51
    serious Num Affected
    21
    serious Num At Risk
    51
    title
    Cohort 3a
  5. deaths Num Affected
    0
    deaths Num At Risk
    33
    description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    id
    EG004
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    12
    serious Num At Risk
    33
    title
    Cohort 3b
  6. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    7
    serious Num Affected
    0
    serious Num At Risk
    7
    title
    PK Sub-Study
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Haemoglobinaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Lymphadenopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Sinus bradycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Lymphadenopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Left ventricular dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Anal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      51
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    term
    Colitis
time Frame
Participants were assessed for All-Cause Mortality, Serious adverse events (SAEs) and Other adverse events (AEs) in all treated participants (up to approximately 14 years 6 months). The participants who crossed over from Cohort 3 to PK Sub-study are accounted for in both arms. PK Sub-study only for the duration of the PK Sub-study.

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