Table 2.
Treatment-emergent adverse events (TEAEs)
1.5% Ruxolitinib cream (n = 41) | |
---|---|
Patients with a TEAE, n (%) | 13 (31.7) |
TEAEs in ≥ 1 patient, n (%) [duration, days] | |
Grade 1 | |
Aspartate aminotransferase increased | 2 (4.9) [16, 16] |
Upper respiratory tract infection | 2 (4.9) [4, 11] |
Alanine aminotransferase increased | 1 (2.4) [16] |
Bronchitis | 1 (2.4) [21] |
Burns first degree | 1 (2.4) [22] |
Constipation | 1 (2.4) [3] |
Cough | 1 (2.4) [1] |
Headache | 1 (2.4) [1] |
Liver function test increased | 1 (2.4) [14] |
Madarosis | 1 (2.4) [12] |
Muscle strain | 1 (2.4) [12] |
Nausea | 1 (2.4) [1] |
Neutropeniaa | 1 (2.4) [21] |
Pruritus | 1 (2.4)b |
Rash | 1 (2.4) [16] |
Restlessness | 1 (2.4)b |
Rhinitis allergic | 1 (2.4) [8] |
Seasonal allergy | 1 (2.4) [4] |
Skin hyperpigmentation | 1 (2.4)b |
Toothache | 1 (2.4) [NA] |
Grade 2 | |
Dyspnea | 1 (2.4) [15] |
Hemoglobin decreasedc | 1 (2.4) [45] |
Hyperkalemia | 1 (2.4) [28] |
Grade 3 | |
Limb abscess | 1 (2.4) [24] |
Patients with treatment-related AE, n (%) | 4 (9.8) |
Serious TEAE, n (%) | 1 (2.4) |
Discontinuation because of a TEAE, n (%) | 1 (2.4) |
Treatment interruption because of a TEAE, n (%) | 3 (7.3) |
AE adverse event, NA not available
aNeutrophil count at baseline, 1.06 × 109/L; neutrophil count on day 26, 1.12 × 109/L; range of plasma ruxolitinib, below limit of quantitation to 3.7 nM
bOngoing at end of study
cHemoglobin level at baseline, 110 g/L; hemoglobin level at day 41, 90 g/L; range of plasma ruxolitinib, below limit of quantitation to 67.9 nM