Table 3.
TRAEs for the intent-to-treat population
| Summary of TRAEs, n (%) | GC/GEJ | ESCC | BTC | Total |
|---|---|---|---|---|
| (n = 20) | (n = 20) | (n = 20) | (N = 60) | |
| Any TRAEs | 20 (100.0) | 19 (95.0) | 19 (95.0) | 58 (96.7) |
| Grade ≥ 3 | 8 (40.0) | 11 (55.0) | 9 (45.0) | 28 (46.7) |
| Surufatinib-related adverse events | 20 (100.0) | 18 (90.0) | 19 (95.0) | 57 (95.0) |
| Grade ≥ 3 | 7 (35.0) | 11 (55.0) | 9 (45.0) | 27 (45.0) |
| Leading to surufatinib dose interruption or dose reduction | 9 (45.0) | 11 (55.0) | 9 (45.0) | 29 (48.3) |
| Toripalimab-related adverse events | 18 (90.0) | 18 (90.0) | 18 (90.0) | 54 (90.0) |
| Grade ≥ 3 | 4 (20.0) | 4 (20.0) | 6 (30.0) | 14 (23.3) |
| Leading to toripalimab interruption | 4 (20.0) | 5 (25.0) | 3 (15.0) | 12 (20.0) |
| Leading to discontinuation of either study drug | 2 (10.0) | 2 (10.0) | 2 (10.0) | 6 (10.0) |
| Leading to discontinuation of surufatinib | 2 (10.0) | 2 (10.0) | 1 (5.0) | 5 (8.3) |
| Leading to discontinuation of toripalimab | 1 (5.0) | 1 (5.0) | 2 (10.0) | 4 (6.7) |
| Leading to death | 1 (5.0) | 1 (5.0) | 0 | 2 (3.3) |
| Treatment-related SAE | 4 (20.0) | 7 (35.0) | 6 (30.0) | 17 (28.3) |
| irAE related to toripalimab | 8 (40.0) | 13 (65.0) | 10 (50.0) | 31 (51.7) |
| Grade ≥ 3 | 1 (5.0) | 2 (10.0) | 2 (10.0) | 5 (8.3) |
irAE immune-related adverse event, TRAE treatment-related adverse event