Table 3.
Adverse Events That Occurred during Treatment (Safety Population).*
| Event | Selpercatinib (N = 158) | Control (N = 98) | ||
|---|---|---|---|---|
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| number of patients (percent) | ||||
| Any event | 158 (100) | 111 (70) | 97 (99) | 56 (57) |
| AST increase | 97 (61) | 20 (13) | 39 (40) | 1 (1) |
| ALT increase | 95 (60) | 35 (22) | 39 (40) | 3 (3) |
| Hypertension | 76 (48) | 32 (20) | 7 (7) | 3 (3) |
| Diarrhea | 70 (44) | 2 (1) | 24 (24) | 2 (2) |
| Edema | 65 (41) | 4 (3) | 27 (28) | 0 |
| Dry mouth | 62 (39) | 0 | 6 (6) | 0 |
| Blood bilirubin increase | 59 (37) | 2 (1) | 1 (1) | 0 |
| Rash | 52 (33) | 3 (2) | 29 (30) | 1 (1) |
| Fatigue | 51 (32) | 5 (3) | 49 (50) | 5 (5) |
| Thrombocytopenia | 42 (27) | 5 (3) | 28 (29) | 7 (7) |
| Abdominal pain | 40 (25) | 1 (1) | 19 (19) | 2 (2) |
| Leukopenia | 40 (25) | 2 (1) | 32 (33) | 7 (7) |
| Blood creatinine increase | 39 (25) | 2 (1) | 17 (17) | 1 (1) |
| Neutropenia | 36 (23) | 3 (2) | 44 (45) | 27 (28) |
| Constipation | 34 (22) | 0 | 39 (40) | 1 (1) |
| QT prolongation on ECG | 32 (20) | 14 (9) | 1 (1) | 0 |
| Decreased appetite | 27 (17) | 0 | 33 (34) | 2 (2) |
| Pyrexia | 21 (13) | 1 (1) | 23 (23) | 0 |
| Nausea | 20 (13) | 0 | 43 (44) | 1 (1) |
| Vomiting | 20 (13) | 0 | 23 (23) | 1 (1) |
| Anemia | 18 (11) | 2 (1) | 58 (59) | 10 (10) |
| Pruritus | 16 (10) | 0 | 22 (22) | 0 |
*
Shown are events that occurred during treatment in at least 20% of the patients in either group. The terms used to describe the adverse events are adapted from or composites of Medical Dictionary for Regulatory Activities, version 25.0, preferred terms. ALT denotes alanine aminotransferase, AST aspartate aminotransferase, and ECG electrocardiogram.