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NCT03614728 · ADVERSE EVENTS

Adverse events

Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) · Source last updated 2023-02-06

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, common non-STEAEs and STEAEs were collected up to 30.8 months in Part 1 of the study
Other-event reporting threshold
5%

All-cause mortality, common non-STEAEs and STEAEs were collected in Part A from All Treated Population. Data has been reported for only Part A and data were not collected for Part 2 as the study was terminated early and no participants were enrolled in Part 2 of the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: GSK3326595 400 mg

Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

11 / 1312 / 1311 / 13
Part 1: GSK3326595 300 mg

Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

12 / 1717 / 1714 / 17

Group identifiers: EG000: Part 1: GSK3326595 400 mg · EG001: Part 1: GSK3326595 300 mg

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
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Septic shock
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Actinomycosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Arthritis bacterial
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Diverticulitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Oral herpes
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Pneumocystis jirovecii pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Pneumonia bacterial
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Vascular device infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Febrile neutropenia

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      17
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      17
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Haemorrhoidal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Oral disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Rectal lesion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Abdominal pain upper
Complete source fields
description
All-cause mortality, common non-STEAEs and STEAEs were collected in Part A from All Treated Population. Data has been reported for only Part A and data were not collected for Part 2 as the study was terminated early and no participants were enrolled in Part 2 of the study.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    13
    description
    Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    13
    serious Num Affected
    11
    serious Num At Risk
    13
    title
    Part 1: GSK3326595 400 mg
  2. deaths Num Affected
    14
    deaths Num At Risk
    17
    description
    Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
    id
    EG001
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    12
    serious Num At Risk
    17
    title
    Part 1: GSK3326595 300 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      17
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      17
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Haemorrhoidal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Oral disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Rectal lesion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Septic shock
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Actinomycosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Arthritis bacterial
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Diverticulitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    term
    Oral herpes
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Pneumocystis jirovecii pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Pneumonia bacterial
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    term
    Vascular device infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    term
    Febrile neutropenia
time Frame
All-cause mortality, common non-STEAEs and STEAEs were collected up to 30.8 months in Part 1 of the study

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