Table 1. Most common a any-grade treatment-related adverse events (TRAEs) in patients with metastatic renal cell carcinoma receiving long-term sunitinib according to interval analysis.
| Any-grade TRAE | Patients, n (%) | ||||||
|---|---|---|---|---|---|---|---|
|
| |||||||
| 0–<6 mo (N = 807) |
0–<1 yr (N = 807) |
1–<2 yr (N = 807) |
2–<3 yr (N = 807) |
3–<4 yr (N = 365) |
4–<5 yr (N = 168) |
5–<6 yr (N = 77) |
|
| Any | 785 (97) | 796 (99) | 783 (97) | 767 (95) | 340 (93) | 157 (93) | 72 (94) |
| Diarrhea | 411 (51) | 533 (66) | 481 (60) | 378 (47) | 153 (42) | 65 (39) | 29 (38) |
| Fatigue | 386 (48) | 433 (54) | 359 (44) | 317 (39) | 130 (36) | 56 (33) | 25 (32) |
| Dysgeusia | 257 (32) | 281 (35) | 170 (21) | 113 (14) | 40 (11) | 15 (9) | 8 (10) |
| Stomatitis | 261 (32) | 288 (36) | 156 (19) | 86 (11) | 25 (7) | 17 (10) | 12 (16) |
| Nausea | 245 (30) | 302 (37) | 195 (24) | 147 (18) | 53 (15) | 26 (15) | 10 (13) |
| Hand–foot syndrome | 242 (30) | 320 (40) | 311 (39) | 251 (31) | 106 (29) | 52 (31) | 22 (29) |
| Hypertension | 222 (28) | 276 (34) | 230 (29) | 204 (25) | 94 (26) | 46 (27) | 23 (30) |
| Decreased appetite | 214 (27) | 262 (32) | 167 (21) | 113 (14) | 34 (9) | 17 (10) | 7 (9) |
| Dyspepsia | 220 (27) | 264 (33) | 182 (23) | 136 (17) | 59 (16) | 27 (16) | 16 (21) |
| Mucosal inflammation | 220 (27) | 248 (31) | 152 (19) | 100 (12) | 40 (11) | 22 (13) | 8 (10) |
| Rash | 152 (19) | 206 (26) | 121 (15) | 77 (10) | 22 (6) | 15 (9) | 5 (6) |
| Thrombocytopenia | 149 (18) | 184 (23) | 84 (10) | 47 (6) | 18 (5) | 3 (2) | 1 (1) |
| Vomiting | 141 (17) | 175 (22) | 109 (14) | 72 (9) | 20 (5) | 14 (8) | 3 (4) |
| Hair color changes | 125 (15) | 156 (19) | 142 (18) | 135 (17) | 62 (17) | 29 (17) | 11 (14) |
| Asthenia | 110 (14) | 136 (17) | 109 (14) | 76 (9) | 30 (8) | 11 (7) | 5 (6) |
| Neutropenia | 110 (14) | 142 (18) | 118 (15) | 70 (9) | 37 (10) | 12 (7) | 4 (5) |
| Skin discoloration | 102 (13) | 127 (16) | 84 (10) | 59 (7) | 29 (8) | 12 (7) | 4 (5) |
| Epistaxis | 94 (12) | 130 (16) | 82 (10) | 50 (6) | 18 (5) | 5 (3) | 2 (3) |
| Pain in extremity | 91 (11) | 141 (17) | 115 (14) | 85 (11) | 34 (9) | 16 (10) | 4 (5) |
| Hypothyroidism | 46 (6) | 110 (14) | 231 (29) | 241 (30) | 118 (32) | 55 (33) | 32 (42) |
a
Occurring in at least 15% of patients in at least one time interval.