NCT01245062 · ADVERSE EVENTS
Adverse events
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.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Trametinib | 52 / 211 | 207 / 211 | 172 / 211 |
| Chemotherapy | 19 / 99 | 88 / 99 | 22 / 99 |
| Cross-over From Chemotherapy to Trametinib | 18 / 70 | 66 / 70 | 53 / 70 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 70
- term
- Cellulitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 70
- term
- Erysipelas
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Bronchitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Eye infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Klebsiella infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Localized infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Lymphangitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Rash pustular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 70
- term
- Sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 70
- term
- Pyrexia
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 123
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 37
- num At Risk
- 70
- term
- Rash
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 70
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 42
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 70
- term
- Dermatitis acneiform
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 70
- term
- Dry skin
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 25
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 70
- term
- Pruritus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 70
- term
- Eczema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 94
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 24
- num At Risk
- 70
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 48
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 70
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 34
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 70
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 33
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 21
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 16
- num At Risk
- 70
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 70
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 99
- 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
- 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
- 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
- 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
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 123
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 37
- num At Risk
- 70
- term
- Rash
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 70
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 42
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 70
- term
- Dermatitis acneiform
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 70
- term
- Dry skin
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 25
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 70
- term
- Pruritus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 70
- term
- Eczema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 94
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 24
- num At Risk
- 70
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 48
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 70
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 34
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 70
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 33
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 21
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 16
- num At Risk
- 70
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 70
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Abdominal pain
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 70
- term
- Cellulitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 70
- term
- Erysipelas
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Bronchitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Eye infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Klebsiella infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Localized infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Lymphangitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 70
- term
- Rash pustular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 99
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 70
- term
- Sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 211
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 99
- 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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