Table 2.
Adverse events, by type and sub-population
| Axitinib |
Placebo |
|||
|---|---|---|---|---|
| Asian n = 260 | Non-Asian n = 100 | Asian n = 264 | Non-Asian n = 96 | |
| Hypertension | 164 (63.1) | 67 (67.0) | 54 (20.5) | 37 (38.5) |
| Diarrhoea | 114 (43.8) | 56 (56.0) | 26 (9.8) | 26 (27.1) |
| Dysphonia | 114 (43.8) | 35 (35.0) | 13 (4.9) | 8 (8.3) |
| PPEa | 90 (34.6) | 25 (25.0) | 12 (4.5) | 5 (5.2) |
| Proteinuriab | 74 (28.5) | 10 (10.0) | 23 (8.7) | 2 (2.1) |
| Fatiguec | 45 (17.3) | 30 (30.0) | 22 (8.3) | 22 (22.9) |
| Hypothyroidism | 58 (22.3) | 15 (15.0) | 17 (6.4) | 5 (5.2) |
| Arthralgia | 35 (13.5) | 24 (24.0) | 18 (6.8) | 18 (18.8) |
| Nasopharyngitisb | 53 (20.4) | 4 (4.0) | 48 (18.2) | 14 (14.6) |
| Increased TSH | 38 (14.6) | 10 (10.0) | 5 (1.9) | — |
| Headache | 31 (11.9) | 17 (17.0) | 24 (9.1) | 16 (16.7) |
| Stomatitis | 34 (13.1) | 12 (12.0) | 6 (2.3) | 3 (3.1) |
| Back pain | 27 (10.4) | 19 (19.0) | 34 (12.9) | 20 (20.8) |
| Rash | 38 (14.6) | 8 (8.0) | 9 (3.4) | 6 (6.3) |
| Decreased appetite | 30 (11.5) | 15 (15.0) | 4 (1.5) | 3 (3.1) |
| Dizziness | 33 (12.7) | 9 (9.0) | 29 (11.0) | 5 (5.2) |
| Astheniab | 8 (3.1) | 33 (33.0) | 1 (0.4) | 21 (21.9) |
| Nausea | 17 (6.5) | 19 (19.0) | 18 (6.8) | 17 (17.7) |
PPE, palmar-plantar erythrodysesthesia syndrome; TSH, thyroid-stimulating hormone.
a
P = 0.022 for axitinib-treated Asian versus non-Asian patients.
b
P < 0.0001 for axitinib-treated Asian versus non-Asian patients.
c
P = 0.0038 for axitinib-treated Asian versus non-Asian patients.