Table 3.
Summary of AEs (APaT Population)
| MK-8353 50 mg + Selumetinib 25 mg n = 3 |
MK-8353 100 mg + Selumetinib 50 mg n = 12 |
MK-8353 150 mg + Selumetinib 75 mg n = 15 |
Total N = 30 |
|
|---|---|---|---|---|
| Any AE | 3 (100) | 12 (100) | 15 (100) | 30 (100) |
| Treatment-related AEsa | 2 (67) | 9 (75) | 15 (100) | 26 (87) |
| Grade 1 | 0 | 4 (33) | 1 (7) | 5 (17) |
| Grade 2 | 1 (33) | 2 (17) | 9 (60) | 12 (40) |
| Grade 3 | 1 (33) | 3 (25) | 5 (33) | 9 (30) |
| Grade 4/5 | 0 | 0 | 0 | 0 |
| Serious | 0 | 0 | 2 (13)b | 2 (7) |
| Led to discontinuation of study treatment | 0 | 2 (17)c | 1 (7)c | 3 (10) |
| Led to interruption of study treatment | 1 (33)d | 1 (8)d | 11 (73)d | 13 (43) |
| Treatment-related AEs occurring in ≥ 10% of patients | ||||
| Diarrhea | 1 (33) | 7 (58) | 12 (80) | 20 (67) |
| Grade 1 | 0 | 6 (50) | 3 (20) | 9 (30) |
| Grade 2 | 1 (33) | 0 | 7 (47) | 8 (27) |
| Grade 3 | 0 | 1 (8) | 2 (13) | 3 (10) |
| Nausea | 0 | 4 (33) | 7 (47) | 11 (37) |
| Grade 1 | 0 | 1 (8) | 3 (20) | 4 (13) |
| Grade 2 | 0 | 3 (25) | 4 (27) | 7 (23) |
| Acneiform dermatitis | 1 (33) | 3 (25) | 6 (40) | 10 (33) |
| Grade 1 | 1 (33) | 3 (25) | 3 (20) | 7 (23) |
| Grade 2 | 0 | 0 | 3 (20) | 3 (10) |
| Vomiting | 0 | 2 (17) | 5 (33) | 7 (23) |
| Grade 1 | 0 | 1 (8) | 2 (13) | 3 (10) |
| Grade 2 | 0 | 1 (8) | 0 | 1 (3) |
| Grade 3 | 0 | 0 | 3 (20) | 3 (10) |
| Fatigue | 0 | 0 | 5 (33) | 5 (17) |
| Grade 1 | 0 | 0 | 2 (13) | 2 (7) |
| Grade 2 | 0 | 0 | 3 (20) | 3 (10) |
| Blood creatine phosphokinase increase | 0 | 0 | 4 (27) | 4 (13) |
| Grade 1 | 0 | 0 | 4 (27) | 4 (13) |
| Abdominal pain | 0 | 1 (8) | 2 (13) | 3 (10) |
| Grade 1 | 0 | 0 | 2 (13) | 2 (7) |
| Grade 2 | 0 | 1 (8) | 0 | 1 (3) |
AE, adverse event; APaT, all patients as treated
aDetermined by the investigator to be related to study treatment. Patients could have experienced ≥ 1 treatment-related AE.
bVomiting (n = 2), diarrhea (n = 1)
cMK-8353 100 mg + selumetinib 50 mg: diarrhea (n = 1), urticaria (n = 1); MK-8353 150 mg + selumetinib 75 mg: retinal detachment (n = 1)
dMK-8353 50 mg + selumetinib 25 mg: diarrhea (n = 1); MK-8353 100 mg + selumetinib 50 mg: mucosal inflammation (n = 1); MK-8353 150 mg + selumetinib 75 mg: diarrhea and vomiting (n = 4 each); alanine aminotransferase increase, blurred vision, nausea, and retinal detachment (n = 2 each); aspartate aminotransferase increase, acneiform dermatitis, bacterial enterocolitis, fatigue, hypomagnesemia, macular edema, myalgia, rectal tenesmus, and retinopathy (n = 1 each)
Data are presented as n (%)