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NCT01943851 · ADVERSE EVENTS

Adverse events

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies · Source last updated 2024-10-01

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
All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
Other-event reporting threshold
5%

All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
GSK525762 5 MG QD

Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.

1 / 11 / 11 / 1
GSK525762 10 MG QD

Participants were administered once daily oral dose of 10 mg GSK525762.

0 / 11 / 10 / 1
GSK525762 20 MG QD

Participants were administered once daily oral dose of 20 mg GSK525762.

0 / 11 / 11 / 1
GSK525762 30 MG QD MM

Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.

4 / 55 / 54 / 5
GSK525762 40 MG QD

Participants were administered once daily oral dose of 40 mg GSK525762.

0 / 11 / 10 / 1
GSK525762 40 MG QD MM

Participants with MM were administered once daily oral dose of 40 mg GSK525762.

3 / 44 / 43 / 4
GSK525762 60 MG QD AML

Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 40 mg GSK525762.

6 / 88 / 87 / 8
GSK525762 60 MG QD NHL

Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.

12 / 1818 / 1812 / 18
GSK525762 60 MG QD MM

Participants with MM were administered once daily oral dose of 60 mg GSK525762.

2 / 33 / 32 / 3
GSK525762 75 MG QD AML

Participants with AML were administered once daily oral dose of 75 mg GSK525762.

8 / 88 / 88 / 8
GSK525762 80 MG QD

Participants were administered once daily oral dose of 80 mg GSK525762.

1 / 11 / 11 / 1
GSK525762 80 MG QD AML

Participants with AML were administered once daily oral dose of 80 mg GSK525762.

6 / 77 / 77 / 7
GSK525762 80 MG QD NHL

Participants with NHL were administered once daily oral dose of 80 mg GSK525762.

7 / 77 / 76 / 7
GSK525762 100 MG QD AML

Participants with AML were administered once daily oral dose of 100 mg GSK525762.

14 / 1616 / 1615 / 16
GSK525762 120 MG QD AML

Participants with AML were administered once daily oral dose of 120 mg GSK525762.

6 / 66 / 66 / 6
GSK525762 60 MG QD CTCL

Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.

5 / 77 / 71 / 7
GSK525762 75 MG QD MDS

Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.

12 / 1616 / 1613 / 16
GSK525762 80 MG QD CTCL

Participants CTCL were administered once daily oral dose of 80 mg GSK525762.

1 / 11 / 10 / 1

Group identifiers: EG000: GSK525762 5 MG QD · EG001: GSK525762 10 MG QD · EG002: GSK525762 20 MG QD · EG003: GSK525762 30 MG QD MM · EG004: GSK525762 40 MG QD · EG005: GSK525762 40 MG QD MM · EG006: GSK525762 60 MG QD AML · EG007: GSK525762 60 MG QD NHL · EG008: GSK525762 60 MG QD MM · EG009: GSK525762 75 MG QD AML · EG010: GSK525762 80 MG QD · EG011: GSK525762 80 MG QD AML · EG012: GSK525762 80 MG QD NHL · EG013: GSK525762 100 MG QD AML · EG014: GSK525762 120 MG QD AML · EG015: GSK525762 60 MG QD CTCL · EG016: GSK525762 75 MG QD MDS · EG017: GSK525762 80 MG QD CTCL

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      18
      num Events
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      8
      num Events
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      1
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      5
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      8
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Neutropenic sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      18
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Respiratory failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Acute kidney injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Blood bilirubin increased

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      6
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      18
      num Events
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      8
      num Events
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      2
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      7
      num Events
      6
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      4
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      18
      num Events
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
      num Events
      2
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      8
      num Events
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      6
      num At Risk
      7
      num Events
      6
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      4
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      18
      num Events
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      8
      num Events
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      1
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Blood bilirubin increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      3
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      18
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Dysgeusia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      18
      num Events
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Hyperglycaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      8
      num Events
      2
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      18
      num Events
      3
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      8
      num Events
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Decreased appetite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      18
      num Events
      3
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
      num Events
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      1
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      4
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      18
      num Events
      8
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      18
      num Events
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      18
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    International normalised ratio increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Hypokalaemia
Complete source fields
description
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    GSK525762 5 MG QD
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants were administered once daily oral dose of 10 mg GSK525762.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    GSK525762 10 MG QD
  3. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants were administered once daily oral dose of 20 mg GSK525762.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    GSK525762 20 MG QD
  4. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    GSK525762 30 MG QD MM
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants were administered once daily oral dose of 40 mg GSK525762.
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    GSK525762 40 MG QD
  6. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants with MM were administered once daily oral dose of 40 mg GSK525762.
    id
    EG005
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    GSK525762 40 MG QD MM
  7. deaths Num Affected
    7
    deaths Num At Risk
    8
    description
    Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 40 mg GSK525762.
    id
    EG006
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    6
    serious Num At Risk
    8
    title
    GSK525762 60 MG QD AML
  8. deaths Num Affected
    12
    deaths Num At Risk
    18
    description
    Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
    id
    EG007
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    12
    serious Num At Risk
    18
    title
    GSK525762 60 MG QD NHL
  9. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Participants with MM were administered once daily oral dose of 60 mg GSK525762.
    id
    EG008
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    GSK525762 60 MG QD MM
  10. deaths Num Affected
    8
    deaths Num At Risk
    8
    description
    Participants with AML were administered once daily oral dose of 75 mg GSK525762.
    id
    EG009
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    8
    serious Num At Risk
    8
    title
    GSK525762 75 MG QD AML
  11. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants were administered once daily oral dose of 80 mg GSK525762.
    id
    EG010
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    GSK525762 80 MG QD
  12. deaths Num Affected
    7
    deaths Num At Risk
    7
    description
    Participants with AML were administered once daily oral dose of 80 mg GSK525762.
    id
    EG011
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    GSK525762 80 MG QD AML
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      6
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      18
      num Events
      8
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      8
      num Events
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      2
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      7
      num Events
      6
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      4
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      18
      num Events
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
      num Events
      2
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      8
      num Events
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      6
      num At Risk
      7
      num Events
      6
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      4
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      18
      num Events
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      8
      num Events
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      1
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Blood bilirubin increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      3
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      18
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Dysgeusia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      18
      num Events
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Hyperglycaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      8
      num Events
      2
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      18
      num Events
      3
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      8
      num Events
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Decreased appetite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      18
      num Events
      3
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
      num Events
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      1
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      4
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      18
      num Events
      8
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      18
      num Events
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      18
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    International normalised ratio increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      8
      num Events
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Hypokalaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      18
      num Events
      9
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      8
      num Events
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      1
      num Events
      1
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      5
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      8
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
      num Events
      3
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Neutropenic sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      18
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      8
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Respiratory failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      8
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Acute kidney injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      18
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      8
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      8
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      18
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      8
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      1
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Blood bilirubin increased
time Frame
All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)

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Preserved source evidence · Not medical advice