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NCT04439188 · ADVERSE EVENTS

Adverse events

Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Loss of Expression (MATCH-Subprotocol P) · Source last updated 2026-05-27

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
Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
Other-event reporting threshold
5%

All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (GSK2636771)

Patients receive PI3K-beta inhibitor GSK2636771 400 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO

8 / 3522 / 3531 / 35

Group identifiers: EG000: Treatment (GSK2636771)

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
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      8
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      8
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      8
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Alkaline phosphatase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Dehydration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      8
    term
    Hypocalcemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      8
    term
    Hypokalemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Hypophosphatemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Dyspnea

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      35
      num Events
      22
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Pruritus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Rash maculo-papular
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Bloating
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      35
      num Events
      22
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Flatulence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      35
      num Events
      22
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
      num Events
      22
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Alkaline phosphatase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      35
      num Events
      22
    term
    Creatinine increased
Complete source fields
description
All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
event Groups
  1. deaths Num Affected
    31
    deaths Num At Risk
    35
    description
    Patients receive PI3K-beta inhibitor GSK2636771 400 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
    id
    EG000
    other Num Affected
    22
    other Num At Risk
    35
    serious Num Affected
    8
    serious Num At Risk
    35
    title
    Treatment (GSK2636771)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      35
      num Events
      22
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Pruritus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Rash maculo-papular
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Bloating
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      35
      num Events
      22
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Flatulence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      35
      num Events
      22
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
      num Events
      22
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      22
    term
    Alkaline phosphatase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      35
      num Events
      22
    term
    Creatinine increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      8
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      8
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      8
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Alkaline phosphatase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Dehydration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      8
    term
    Hypocalcemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      8
    term
    Hypokalemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Hypophosphatemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      8
    term
    Dyspnea
time Frame
Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.

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