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NCT01742286 · ADVERSE EVENTS

Adverse events

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) · Source last updated 2020-06-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
Other-event reporting threshold
5%

AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Fasted Ceritinib 300mg/m2

Participants in the fasted group who took 300 mg of ceritinib

1 / 55 / 51 / 5
Fasted Ceritinib 450mg/m2

Participants in the fasted group who took 450 mg of ceritinib

4 / 1212 / 121 / 12
Fasted Ceritinib 510mg/m2

Participants in the fasted group who took 510 mg of ceritinib

8 / 1313 / 132 / 13
Fasted Ceritinib 560mg/m2

Participants in the fasted group who took 560 mg of ceritinib

2 / 22 / 20 / 2
Fed Ceritinib 320mg/m2

Participants in the fed group who took 320 mg of ceritinib

3 / 44 / 42 / 4
Fed Ceritinib 400mg/m2

Participants in the fed group who took 400 mg of ceritinib

1 / 55 / 51 / 5
Fed Ceritinib 500mg/m2

Participants in the fed group who took 500 mg of ceritinib

21 / 4242 / 425 / 42
Fasted+Fed All Patients

All participants in the Fasted and Fed groups

40 / 8383 / 8312 / 83

Group identifiers: EG000: Fasted Ceritinib 300mg/m2 · EG001: Fasted Ceritinib 450mg/m2 · EG002: Fasted Ceritinib 510mg/m2 · EG003: Fasted Ceritinib 560mg/m2 · EG004: Fed Ceritinib 320mg/m2 · EG005: Fed Ceritinib 400mg/m2 · EG006: Fed Ceritinib 500mg/m2 · EG007: Fasted+Fed All Patients

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      83
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Dental caries
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Gastric haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Small intestinal haemorrhage

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      22
      num At Risk
      83
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Bone marrow disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      83
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Lymphadenopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      83
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      83
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Left ventricular dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      83
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      83
    term
    Ear pain
Complete source fields
description
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Participants in the fasted group who took 300 mg of ceritinib
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Fasted Ceritinib 300mg/m2
  2. deaths Num Affected
    1
    deaths Num At Risk
    12
    description
    Participants in the fasted group who took 450 mg of ceritinib
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    4
    serious Num At Risk
    12
    title
    Fasted Ceritinib 450mg/m2
  3. deaths Num Affected
    2
    deaths Num At Risk
    13
    description
    Participants in the fasted group who took 510 mg of ceritinib
    id
    EG002
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    8
    serious Num At Risk
    13
    title
    Fasted Ceritinib 510mg/m2
  4. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants in the fasted group who took 560 mg of ceritinib
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Fasted Ceritinib 560mg/m2
  5. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants in the fed group who took 320 mg of ceritinib
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Fed Ceritinib 320mg/m2
  6. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Participants in the fed group who took 400 mg of ceritinib
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Fed Ceritinib 400mg/m2
  7. deaths Num Affected
    5
    deaths Num At Risk
    42
    description
    Participants in the fed group who took 500 mg of ceritinib
    id
    EG006
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    21
    serious Num At Risk
    42
    title
    Fed Ceritinib 500mg/m2
  8. deaths Num Affected
    12
    deaths Num At Risk
    83
    description
    All participants in the Fasted and Fed groups
    id
    EG007
    other Num Affected
    83
    other Num At Risk
    83
    serious Num Affected
    40
    serious Num At Risk
    83
    title
    Fasted+Fed All Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      22
      num At Risk
      83
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Bone marrow disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      83
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Lymphadenopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      83
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      83
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Left ventricular dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      83
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      83
    term
    Ear pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      83
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Dental caries
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Gastric haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
    term
    Small intestinal haemorrhage
time Frame
Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.

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Preserved source evidence · Not medical advice