Table 2.
Adverse events occurring in > 30% of patients in any treatment arma
| AE, n (%) | D + P (n = 20) | T + P (n = 51)b | D + T + P (n = 91) | |||
|---|---|---|---|---|---|---|
| Total | Grade 3/4 | Total | Grade 3/4 | Total | Grade 3/4 | |
| Any event | 20 (100) | 9 (45) | 50 (98) | 34 (67) | 91 (100) | 64 (70) |
| Diarrhea | 9 (45) | 0 | 37 (73) | 1 (2) | 59 (65) | 6 (7) |
| Dermatitis acneiform | 12 (60) | 0 | 27 (53) | 9 (18) | 54 (59) | 9 (10) |
| Nausea | 10 (50) | 0 | 18 (35) | 1 (2) | 51 (56) | 2 (2) |
| Dry skin | 7 (35) | 1 (5) | 17 (33) | 3 (6) | 49 (54) | 2 (2) |
| Fatigue | 10 (50) | 0 | 13 (25) | 0 | 45 (49) | 6 (7) |
| Pyrexia | 7 (35) | 0 | 20 (39) | 0 | 44 (48) | 4 (4) |
| Vomiting | 6 (30) | 0 | 15 (29) | 1 (2) | 39 (43) | 2 (2) |
| Decreased appetite | 5 (25) | 0 | 12 (24) | 0 | 36 (40) | 2 (2) |
| Rash | 3 (15) | 0 | 16 (31) | 3 (6) | 28 (31) | 10 (11) |
| Hypomagnesemia | 8 (40) | 1 (5) | 12 (24) | 2 (4) | 26 (29) | 1 (1) |
| Constipation | 7 (35) | 1 (5) | 7 (14) | 0 | 17 (19) | 1 (1) |
a
Safety data were based on the most recent interim analyses (data cutoff May 6, 2016). The median follow-up time (defined as time in months from study start to last contact or death) for patients treated with D + P was 10.6 months (2.1–22 months), for patients treated with D + T + P was 6.2 months (1.5–47.2 months), and for patients with a BRAFV600E mutation treated with T + P was 6.4 months (0.4–18.6 months).
b
Safety data for the T + P arm are for all patients, including those with BRAF wild type (n = 20) and BRAFV600E (n = 31).