Table 2.
Summary of adverse events considered possibly related to study drug (in ≥2 patients in overall population)
| Preferred term | Overall AEs (N = 12) | 150 mg LY3023414 (n = 3) | 200 mg LY3023414 (n = 9) | ||
|---|---|---|---|---|---|
| Any grade | n (%) | n (%) | |||
| n (%) | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Stomatitis | 9 (75.0) | 2 (66.7) | 0 | 7 (77.8) | 2 (22.2) |
| Nausea | 8 (66.7) | 2 (66.7) | 0 | 6 (66.7) | 0 |
| Appetite decreased | 7 (58.3) | 1 (33.3) | 0 | 6 (66.7) | 0 |
| Diarrhea | 5 (41.7) | 1 (33.3) | 0 | 4 (44.4) | 0 |
| Anemia | 5 (41.7) | 2 (66.7) | 1 (33.3) | 3 (33.3) | 1 (11.1) |
| Fatigue | 4 (33.3) | 2 (66.7) | 0 | 2 (22.2) | 0 |
| Hyperglycemia | 4 (33.3) | 2 (66.7) | 1 (33.3) | 2 (22.2) | 1 (11.1) |
| Hypophosphatemia | 4 (33.3) | 1 (33.3) | 0 | 3 (33.3) | 2 (22.2) |
| Proteinuria | 4 (33.3) | 1 (33.3) | 0 | 3 (33.3) | 0 |
| Vomiting | 4 (33.3) | 1 (33.3) | 0 | 3 (33.3) | 0 |
| Blood creatinine increased | 4 (33.3) | 1 (33.3) | 0 | 3 (33.3) | 0 |
| ALT increased | 3 (25.0) | 1 (33.3) | 0 | 2 (22.2) | 0 |
| AST increased | 3 (25.0) | 0 | 0 | 3 (33.3) | 0 |
| Rash | 3 (25.0) | 1 (33.3) | 0 | 2 (22.2) | 0 |
| Pruritis | 3 (25.0) | 1 (33.3) | 0 | 2 (22.2) | 0 |
| Hypokalemia | 2 (16.7) | 1 (33.3) | 0 | 1 (11.1) | 0 |
| Hypotension | 2 (16.7) | 0 | 0 | 2 (22.2) | 0 |
| Pyrexia | 2 (16.7) | 0 | 0 | 2 (22.2) | 0 |
| Weight decreased | 2 (16.7) | 1 (33.3) | 0 | 1 (11.1) | 0 |
| Hematological AEs | |||||
| Platelet count decreased | 5 (41.7) | 2 (66.7) | 0 | 3 (33.3) | 0 |
| WBC count decreased | 2 (16.7) | 0 | 0 | 2 (22.2) | 0 |
AEs adverse events, ALT alanine aminotransferase, AST aspartate aminotransferase, N number of patients in safety population, n number of patients in the specified category, WBC white blood cell