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NCT01266967 · ADVERSE EVENTS

Adverse events

A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain · Source last updated 2014-05-08

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
Serious adverse events (SAEs) and non-serious AEs were collected from the time the first dose of study treatment was administered until 30 days following discontinuation of study treatment (up to 103 weeks).
Other-event reporting threshold
5%

SAEs and non-serious AEs were collected in the All Treated Subjects (ATS) Population, comprised of all participants who received at least one dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
GSK2118436 150 mg: No Prior Local Therapy

Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

26 / 8979 / 89Not reported / Not reported
GSK2118436 150 mg: Prior Local Therapy

Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

31 / 8374 / 83Not reported / Not reported

Group identifiers: EG000: GSK2118436 150 mg: No Prior Local Therapy · EG001: GSK2118436 150 mg: Prior Local Therapy

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      83
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    term
    Haemorrhage intracranial
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      83
    term
    Squamous cell carcinoma
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Headache
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    term
    Hypotension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Ejection fraction decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Pancytopenia

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
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      83
    term
    Headache
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      83
    term
    Hyperkeratosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      83
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      83
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      83
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      83
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      83
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      83
    term
    Rash
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      83
    term
    Alopecia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      83
    term
    Myalgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      83
    term
    Palmar-plantar erythrodysaesthesia syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      83
    term
    Skin papilloma
Complete source fields
description
SAEs and non-serious AEs were collected in the All Treated Subjects (ATS) Population, comprised of all participants who received at least one dose of study medication.
event Groups
  1. description
    Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
    id
    EG000
    other Num Affected
    79
    other Num At Risk
    89
    serious Num Affected
    26
    serious Num At Risk
    89
    title
    GSK2118436 150 mg: No Prior Local Therapy
  2. description
    Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
    id
    EG001
    other Num Affected
    74
    other Num At Risk
    83
    serious Num Affected
    31
    serious Num At Risk
    83
    title
    GSK2118436 150 mg: Prior Local Therapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      83
    term
    Headache
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      83
    term
    Hyperkeratosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      83
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      83
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      83
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      83
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      83
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      83
    term
    Rash
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      83
    term
    Alopecia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      83
    term
    Myalgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      83
    term
    Palmar-plantar erythrodysaesthesia syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      83
    term
    Skin papilloma
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      83
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    term
    Haemorrhage intracranial
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      83
    term
    Squamous cell carcinoma
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Headache
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    term
    Hypotension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Ejection fraction decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Pancytopenia
time Frame
Serious adverse events (SAEs) and non-serious AEs were collected from the time the first dose of study treatment was administered until 30 days following discontinuation of study treatment (up to 103 weeks).

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