Table 6.
Adverse events during the blinded phase
| Adverse event | Ruxolitinib (n = 54) | HC (n = 56) | ||
|---|---|---|---|---|
| All Gradesa | Grade 3/4a | All Gradesa | Grade 3/4a | |
| Nonhaematological,b n (%) | ||||
| Fatigue | 11 (20·4) | 1 (1·9) | 6 (10·7) | 1 (1·8) |
| Headache | 9 (16·7) | 0 | 3 (5·4) | 0 |
| Dizziness | 7 (13·0) | 0 | 5 (8·9) | 0 |
| Nausea | 6 (11·1) | 0 | 3 (5·4) | 0 |
| Pruritus | 6 (11·1) | 0 | 6 (10·7) | 0 |
| Rash | 6 (11·1) | 0 | 0 | 0 |
| Diarrhoea | 5 (9·3) | 0 | 11 (19·6) | 0 |
| Constipation | 4 (7·4) | 0 | 7 (12·5) | 0 |
| Haematological,c n/N (%) | ||||
| Anaemia | 20/54 (37·0) | 0 | 13/56 (23·2) | 1/55 (1·8) |
| Thrombocytopaenia | 5/54 (9·3) | 0 | 15/56 (26·8) | 1/55 (1·8) |
| Leucopaenia | 6/54 (11·1) | 1/54 (1·9) | 13/56 (23·2) | 1/55 (1·8) |
| Lymphopaenia | 10/54 (18·5) | 3/50 (6·0) | 20/56 (35·7) | 2/49 (4·1) |
| Neutropaenia | 2/54 (3·7) | 2/54 (3·7) | 7/56 (12·5) | 1/54 (1·9) |
HC, hydroxycarbamide.
a
Per the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3·0.
b
Adverse events reported by >10% of patients in either arm.
c
New or worsening haematology laboratory values; n indicates the number of patients with abnormal laboratory values, N indicates the number of evaluable patients (patients were evaluable for new or worsening grade 3/4 haematology laboratory values if post‐baseline data were available and data were missing at baseline or the severity at baseline was grade ≤2).