Table 2.
Overall summary of TEAE
| n (%) | 25 mg (N = 1) | 50 mg (N = 4) | 100 mg (N = 4) | 200 mg (N = 5) | 250 mg (N = 5) | 300 mg (N = 4) | Total (N = 23) |
|---|---|---|---|---|---|---|---|
| Subjects with any TEAE | 1 (100.0) | 3 (75.0) | 4 (100.0) | 5 (100.0) | 5 (100.0) | 4 (100.0) | 22 (95.7) |
| Grade 3a | 0 (0.0) | 0 (0.0) | 1 (25.0) | 1 (20.0) | 1 (20.0) | 3 (75.0) | 6 (26.1) |
| SAE | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 2 (8.7) |
| Leading to treatment interruption | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 1 (20.0) | 3 (75.0) | 5 (21.7) |
| Leading to dose reduction | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (75.0) | 3 (13.0) |
| Leading to treatment discontinuation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 1 (4.3) |
| Leading to death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Subjects with any drug-related TEAEb | 1 (100.0) | 3 (75.0) | 4 (100.0) | 5 (100.0) | 4 (80.0) | 4 (100.0) | 21 (91.3) |
| Grade 3a | 0 (0.0) | 0 (0.0) | 1 (25.0) | 1 (20.0) | 0 (0.0) | 2 (50.0) | 4 (17.4) |
| SAE | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.3) |
| Leading to treatment interruption | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 2 (50.0) | 3 (13.0) |
| Leading to dose reduction | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (75.0) | 3 (13.0) |
| Leading to treatment discontinuation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Leading to death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, N number of subjects in the analysis set for each treatment group, SAE Serious Adverse Event, TEAE treatment-emergent adverse event. The percentage was calculated based on N as the denominator
aAdverse event grades were evaluated by investigators according to CTCAE version 5.0
bAEs with missing relationships were reported as related