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NCT01245062 · ADVERSE EVENTS

Adverse events

GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma · Source last updated 2018-04-05

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
Participants were analyzed from the first dose of study medication to 28 days after discontinuation of study medication (average of 20.3 months in the Randomization Phase and 18.3 months in the Cross-over Phase).
Other-event reporting threshold
5%

Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants included in the study who received at least one dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trametinib

Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.

52 / 211207 / 211172 / 211
Chemotherapy

Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.

19 / 9988 / 9922 / 99
Cross-over From Chemotherapy to Trametinib

Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.

18 / 7066 / 7053 / 70

Group identifiers: EG000: Trametinib · EG001: Chemotherapy · EG002: Cross-over From Chemotherapy to Trametinib

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
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Cellulitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Erysipelas
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Eye infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Klebsiella infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Localized infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Lymphangitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Rash pustular
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Pyrexia

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      70
    term
    Rash
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      70
    term
    Alopecia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      70
    term
    Dermatitis acneiform
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      70
    term
    Dry skin
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      70
    term
    Pruritus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      70
    term
    Eczema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      70
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      70
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      70
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      70
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      70
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Abdominal pain
Complete source fields
description
Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants included in the study who received at least one dose of study medication.
event Groups
  1. deaths Num Affected
    172
    deaths Num At Risk
    211
    description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
    id
    EG000
    other Num Affected
    207
    other Num At Risk
    211
    serious Num Affected
    52
    serious Num At Risk
    211
    title
    Trametinib
  2. deaths Num Affected
    22
    deaths Num At Risk
    99
    description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
    id
    EG001
    other Num Affected
    88
    other Num At Risk
    99
    serious Num Affected
    19
    serious Num At Risk
    99
    title
    Chemotherapy
  3. deaths Num Affected
    53
    deaths Num At Risk
    70
    description
    Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
    id
    EG002
    other Num Affected
    66
    other Num At Risk
    70
    serious Num Affected
    18
    serious Num At Risk
    70
    title
    Cross-over From Chemotherapy to Trametinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      70
    term
    Rash
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      70
    term
    Alopecia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      70
    term
    Dermatitis acneiform
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      70
    term
    Dry skin
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      70
    term
    Pruritus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      70
    term
    Eczema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      70
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      70
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      70
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      70
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      70
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Cellulitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Erysipelas
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Eye infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Klebsiella infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Localized infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Lymphangitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Rash pustular
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      211
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Pyrexia
time Frame
Participants were analyzed from the first dose of study medication to 28 days after discontinuation of study medication (average of 20.3 months in the Randomization Phase and 18.3 months in the Cross-over Phase).

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Preserved source evidence · Not medical advice