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NCT02431260 · ADVERSE EVENTS

Adverse events

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies · Source last updated 2019-06-14

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

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

Collection time frame
From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
Other-event reporting threshold
5%

The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1 / Treatment Group A: 15 MG QD INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

1 / 44 / 44 / 4
Part 1 / Treatment Group A: 22.5 MG QD INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

1 / 55 / 54 / 5
Part 1 / Treatment Group A: 15 MG BID INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

1 / 66 / 63 / 6
Part 1 / Treatment Group A: 30 MG QD INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

1 / 55 / 54 / 5
Part 1 / Treatment Group A: 22.5 MG BID INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

3 / 33 / 32 / 3
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.

3 / 44 / 42 / 4
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.

1 / 44 / 43 / 4
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.

1 / 33 / 31 / 3
Part 1 / Treatment Group A: 20 MG BID INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

3 / 88 / 86 / 8
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.

3 / 88 / 86 / 8
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.

1 / 42 / 43 / 4
Part 1 / Treatment Group B: 20 MG BID INCB054329

Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.

3 / 44 / 42 / 4
Part 2 / Treatment Group A: 20 MG BID INCB054329

Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.

3 / 1010 / 106 / 10
Part 2 / Treatment Group C: 20 mg BID INCB054329

Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.

1 / 11 / 11 / 1

Group identifiers: EG000: Part 1 / Treatment Group A: 15 MG QD INCB054329 · EG001: Part 1 / Treatment Group A: 22.5 MG QD INCB054329 · EG002: Part 1 / Treatment Group A: 15 MG BID INCB054329 · EG003: Part 1 / Treatment Group A: 30 MG QD INCB054329 · EG004: Part 1 / Treatment Group A: 22.5 MG BID INCB054329 · EG005: Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329 · EG006: Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329 · EG007: Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329 · EG008: Part 1 / Treatment Group A: 20 MG BID INCB054329 · EG009: Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329 · EG010: Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329 · EG011: Part 1 / Treatment Group B: 20 MG BID INCB054329 · EG012: Part 2 / Treatment Group A: 20 MG BID INCB054329 · EG013: Part 2 / Treatment Group C: 20 mg BID INCB054329

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Ileus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Intra-abdominal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Large intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      4
    term
    Nausea

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Mouth haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Stomatitis
Complete source fields
description
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Part 1 / Treatment Group A: 15 MG QD INCB054329
  2. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Part 1 / Treatment Group A: 22.5 MG QD INCB054329
  3. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Part 1 / Treatment Group A: 15 MG BID INCB054329
  4. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Part 1 / Treatment Group A: 30 MG QD INCB054329
  5. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Part 1 / Treatment Group A: 22.5 MG BID INCB054329
  6. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG005
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
  7. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
  8. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG007
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
  9. deaths Num Affected
    6
    deaths Num At Risk
    8
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG008
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Part 1 / Treatment Group A: 20 MG BID INCB054329
  10. deaths Num Affected
    6
    deaths Num At Risk
    8
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG009
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
  11. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    EG010
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
  12. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
    id
    EG011
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Part 1 / Treatment Group B: 20 MG BID INCB054329
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Mouth haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Ileus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Intra-abdominal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
    term
    Large intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      4
    term
    Nausea
time Frame
From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.

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Preserved source evidence · Not medical advice