Table 3:
Adverse Events in Selpercatinib Treated Patients with RET-mutant MTC and RET fusion-positive thyroid cancer (N=162)
| Adverse Event | Adverse Events, Regardless of Attribution | Treatment-Related Adverse Events | ||||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| No. (percent of patients with event) | ||||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Any Grade | Grade 3 | Grade 4 | Any Grade | |
| Any adverse event | 9 (6) | 42 (26) | 95 (59) | 11 (7) | 162 (100) | 45 (28) | 3 (2) | 153 (94) |
| Dry mouth | 69 (43) | 5 (3) | 0 | 0 | 74 (46) | 0 | 0 | 63 (39) |
| Hypertension | 10 (6) | 25 (15) | 34 (21) | 0 | 69 (43) | 19 (12) | 0 | 49 (30) |
| Diarrhea | 44 (27) | 8 (5) | 9 (6) | 0 | 61 (38) | 4 (3) | 0 | 27 (17) |
| Fatigue | 35 (22) | 24 (15) | 2 (1) | 0 | 61 (38) | 1 (1) | 0 | 41 (25) |
| Aspartate aminotransferase increased | 37 (23) | 6 (4) | 13 (8) | 1 (1) | 57 (35) | 12 (7) | 1 (1) | 45 (28) |
| Nausea | 44 (27) | 13 (8) | 0 | 0 | 57 (35) | 0 | 0 | 25 (15) |
| Constipation | 44 (27) | 11 (7) | 1 (1) | 0 | 56 (35) | 0 | 0 | 26 (16) |
| Alanine aminotransferase increased | 26 (16) | 7 (4) | 17 (11) | 1 (1) | 51 (32) | 16 (10) | 1 (1) | 42 (26) |
| Headache | 36 (22) | 11 (7) | 4 (3) | 0 | 51 (32) | 1 (1) | 0 | 21 (13) |
| Edema peripheral | 42 (26) | 5 (3) | 1 (1) | 0 | 48 (30) | 0 | 0 | 29 (18) |
| Blood creatinine increased | 27 (17) | 12 (7) | 0 | 0 | 39 (24) | 0 | 0 | 22 (14) |
| Abdominal pain | 25 (15) | 8 (5) | 5 (3) | 0 | 38 (24) | 0 | 0 | 6 (4) |
| Arthralgia | 25 (15) | 10 (6) | 0 | 0 | 35 (22) | 0 | 0 | 8 (5) |
| Vomiting | 26 (16) | 8 (5) | 1 (1) | 0 | 35 (22) | 0 | 0 | 12 (7) |
| Hypocalcemia | 14 (9) | 13 (8) | 6 (4) | 1 (1) | 34 (21) | 0 | 0 | 5 (3) |
| Back pain | 19 (12) | 10 (6) | 2 (1) | 0 | 31 (19) | 0 | 0 | 1 (1) |
| Electrocardiogram QT prolonged | 11 (7) | 16 (10) | 4 (3) | 0 | 31 (19) | 3 (2) | 0 | 21 (13) |
| Cough | 25 (15) | 4 (3) | 0 | 0 | 29 (18) | 0 | 0 | 2 (1) |
| Rash | 25 (15) | 3 (2) | 0 | 0 | 28 (17) | 0 | 0 | 13 (8) |
| Dizziness | 25 (15) | 2 (1) | 0 | 0 | 27 (17) | 0 | 0 | 9 (6) |
| Abdominal distension | 18 (11) | 7 (4) | 0 | 0 | 25 (15) | 0 | 0 | 12 (7) |
| Hypothyroidism | 14 (9) | 11 (7) | 0 | 0 | 25 (15) | 0 | 0 | 12 (7) |
| Weight increased | 11 (7) | 9 (6) | 5 (3) | 0 | 25 (15) | 1 (1) | 0 | 8 (5) |
*
The adverse events listed here are those that occurred at any grade in at least 15% of patients, regardless of attribution. The relatedness of adverse events to treatment was determined by the investigators. Total % for any given AE may be different than the sum of the individual grades, due to rounding.
In total, 5 patients experienced grade 5 adverse events including hemoptysis, post-procedure hemorrhage, sepsis, cardiac arrest, and cardiac failure (one each), all deemed unrelated to selpercatinib.