Table 2 Adverse events occurring in ≥10% of patients, regardless of causality
Adverse event | GSK2256098 250 mg BID + 0.5 mg trametinib QD (N = 10) | GSK2256098 500 mg BID + 0.25 mg trametinib QD (N = 8) | GSK2256098 500 mg BID + 0.375 mg trametinib QD (N = 6) | GSK2256098 500 mg BID + 0.5 mg trametinib QD (N = 7) | GSK2256098 500 mg BID + 1.0 mg trametinib QD (N = 3) | Total (N = 34) |
---|---|---|---|---|---|---|
Any event, n (%) | 10 (100) | 8 (100) | 6 (100) | 7 (100) | 3 (100) | 34 (100) |
Nausea | 5 (50) | 4 (50) | 3 (50) | 5 (71) | 3 (100) | 20 (59) |
Diarrhoea | 5 (50) | 3 (38) | 4 (67) | 3 (43) | 3 (100) | 18 (53) |
Decreased appetite | 4 (40) | 1 (13) | 2 (33) | 5 (71) | 1 (33) | 13 (38) |
Fatigue | 2 (20) | 3 (38) | 1 (17) | 2 (29) | 2 (67) | 10 (29) |
Pruritus | 3 (30) | 3 (38) | 0 | 1 (14) | 3 (100) | 10 (29) |
Rash | 3 (30) | 2 (25) | 0 | 2 (29) | 2 (67) | 9 (26) |
Vomiting | 1 (10) | 1 (13) | 1 (17) | 4 (57) | 1 (33) | 8 (24) |
Asthenia | 2 (20) | 0 | 3 (50) | 2 (29) | 0 | 7 (21) |
Cough | 2 (20) | 2 (25) | 2 (33) | 1 (14) | 0 | 7 (21) |
Dermatitis acneiform | 1 (10) | 3 (38) | 2 (33) | 0 | 1 (33) | 7 (21) |
Constipation | 3 (30) | 2 (25) | 0 | 0 | 0 | 5 (15) |
Dyspnoea | 1 (10) | 2 (25) | 1 (17) | 1 (14) | 0 | 5 (15) |
Folliculitis | 3 (30) | 0 | 2 (33) | 0 | 0 | 5 (15) |
Anaemia | 2 (20) | 0 | 0 | 2 (29) | 0 | 4 (12) |
Gastro-oesophageal reflux disease | 1 (10) | 1 (13) | 0 | 2 (29) | 0 | 4 (12) |
Oedema peripheral | 1 (10) | 1 (13) | 1 (17) | 0 | 1 (33) | 4 (12) |