Table 4.
Summary of safety and most common AEs (n = 36)
| Category, n (%) | Values |
|---|---|
| Any AE | 36 (100) |
| Treatment related | 27 (75) |
| AEs leading to discontinuation of any study treatment | 6 (17) |
| AEs leading to dose reduction | 17 (47) |
| AEs leading to dose interruption | 18 (50) |
| Serious AEs | 20 (56) |
| Treatment related | 7 (19) |
| Fatal | 3 (8) |
| Treatment related | 0 (0) |
| AEs, n (%)a | Any Grade | Grade 3/4 |
|---|---|---|
| Any | 36 (100) | 21 (58) |
| Pyrexia | 17 (47) | 0 (0) |
| Anemia | 13 (36) | 7 (19) |
| Decreased appetite | 12 (33) | 1 (3) |
| Fatigue | 12 (33) | 3 (8) |
| Nausea | 12 (33) | 0 (0) |
| Rash | 10 (28) | 0 (0) |
| Dyspnea | 9 (25) | 1 (3) |
| Pneumonia | 9 (25) | 7 (19) |
| Chills | 8 (22) | 0 (0) |
| Constipation | 8 (22) | 0 (0) |
| Dizziness | 8 (22) | 1 (3) |
| Hyponatremia | 8 (22) | 6 (17) |
| Diarrhea | 7 (19) | 1 (3) |
| Headache | 7 (19) | 0 (0) |
| Hypoalbuminemia | 7 (19) | 2 (6) |
| Blood AP increased | 6 (17) | 2 (6) |
| Dysphagia | 6 (17) | 0 (0) |
| Hypotension | 6 (17) | 2 (6) |
| Vomiting | 6 (17) | 0 (0) |
AE, adverse event; AP, alkaline phosphatase; ATC, anaplastic thyroid cancer.
a
All-cause AEs of any grade that occurred in >15% of patients in the ATC cohort.