Table 2.
Incidence of common (at least 15% incidence) TEAEs with vismodegib and sonidegib by CTC grade
| Sonidegib 200 mg n = 79 |
Vismodegib 150 mg n = 119 |
P value* | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| All TEAEs | Grade 1 | Grade 2 | Grade 3 | Grade 4 | All TEAEs | Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||
| Muscle spasm | 43 (54.4) | 35 (44.3) | 6 (7.6) | 2 (2.5) | 0 | 84 (70.6) | 63 (52.9) | 19 (16.0) | 2 (1.7) | 0 | 0.0236 |
| Dysgeusia | 35 (44.3) | 25 (31.6) | 10 (12.7) | 0 | 0 | 84 (70.6) | 68 (57.1) | 16 (13.4) | 0 | 0 | 0.0003 |
| Alopecia | 39 (49.4) | 29 (36.7) | 10 (12.7) | 0 | 0 | 69 (58.0) | 57 (47.9) | 12 (10.1) | 0 | 0 | 0.2469 |
| Diarrhea | 25 (31.6) | 21 (26.6) | 3 (3.8) | 1 (1.3) | 0 | 30 (25.2) | 23 (19.3) | 5 (4.2) | 1 (0.8) | 1 (0.8) | 0.3353 |
| Nausea | 31 (39.2) | 21 (26.6) | 9 (11.4) | 1 (1.3) | 0 | 23 (19.3) | 19 (16.0) | 4 (3.4) | 0 | 0 | 0.0032 |
| Fatigue | 26 (32.9) | 16 (20.3) | 9 (11.4) | 1 (1.3) | 0 | 23 (19.3) | 14 (11.8) | 8 (6.7) | 1 (0.8) | 0 | 0.0429 |
| Weight decrease | 24 (30.4) | 13 (16.5) | 7 (8.9) | 4 (5.1) | 0 | 19 (16.0) | 12 (10.1) | 7 (5.9) | 0 | 0 | 0.0217 |
Data presented as n (%)
TEAE treatment-emergent adverse event, CTC Common Terminology Criteria
*Two-sided Fisher’s exact test for all TEAEs