Table 6.
Common treatment-emergent, all-causality AEs reported by Japanese patients in each treatment arm
| AE, n (%)a | Axitinib titration n = 6 | Placebo titration n = 5 | Non-randomized n = 32 | |||
|---|---|---|---|---|---|---|
| All-grade | Grade 3/4 | All-grade | Grade 3/4 | All-grade | Grade 3/4 | |
| Hypertension | 5 (83) | 3 (50) | 5 (100) | 2 (40) | 29 (91) | 23 (72) |
| Diarrhea | 5 (83) | 0 | 5 (100) | 0 | 23 (72) | 1 (3) |
| Hypothyroidism | 5 (83)b | 0 | 3 (60) | 0 | 22 (69) | 0 |
| Hand–foot syndrome | 5 (83) | 1 (17) | 5 (100) | 0 | 22 (69) | 5 (16) |
| Dysphonia | 4 (67) | 0 | 5 (100)c | 0 | 21 (66) | 0 |
| Proteinuria | 3 (50) | 1 (17) | 4 (80)c | 0 | 20 (63) | 0 |
| Fatigue | 3 (50) | 0 | 3 (60) | 0 | 15 (47) | 2 (6) |
| Decreased appetite | 5 (83)b | 0 | 3 (60) | 0 | 13 (41) | 3 (9) |
| Nasopharyngitis | 1 (17) | 0 | 1 (20) | 0 | 12 (38) | 0 |
| Stomatitis | 2 (33) | 0 | 2 (40) | 0 | 11 (34) | 0 |
| Alopecia | 0 | 0 | 0 | 0 | 9 (28) | 0 |
| Epistaxis | 1 (17) | 0 | 0 | 0 | 8 (25) | 0 |
| Hyperuricemia | 0 | 0 | 0 | 0 | 8 (25) | 1 (3) |
| Weight decreased | 3 (50) | 1 (17) | 2 (40) | 0 | 8 (25) | 1 (3) |
| Dysgeusia | 3 (50) | 0 | 2 (40) | 0 | 7 (22) | 0 |
| Headache | 0 | 0 | 1 (20)c | 0 | 7 (22) | 0 |
| Nausea | 2 (33) | 0 | 2 (40) | 0 | 7 (22) | 1 (3) |
aReported by ≥20% of patients in the non-randomized arm.
b≥20% higher in the axitinib-titration than the placebo-titration arm.
c≥20% higher in the placebo-titration than the axitinib-titration arm.