Table 3 Exposure-adjusted rates of select adverse events
Median duration of exposure, d | Ruxolitinib randomized (n = 155) | Ruxolitinib crossover (n = 111)* | During placebo treatment (n = 151)* | |||
|---|---|---|---|---|---|---|
1045.0 | 777.0 | 260.0 | ||||
All grade | Grade 3 or 4 | All grade | Grade 3 or 4 | All grade | Grade 3 or 4 | |
Event, n/PYE (rate per 100 PYE) | ||||||
 Infections and infestationsa | ||||||
  Upper respiratory tract infection | 34/398.0 (8.5) | 0 | 22/230.5 (9.5) | 0 | 15/96.9 (15.5) | 1/96.9 (1.0) |
  Urinary tract infection | 31/414.3 (7.5) | 4/414.3 (1.0) | 16/240.5 (6.7) | 3/240.5 (1.2) | 7/101.3 (6.9) | 1/101.3 (1.0) |
  Pneumonia | 31/432.3 (7.2) | 22/432.3 (5.1) | 18/253.6 (7.1) | 8/253.6 (3.2) | 11/102.4 (10.7) | 8/102.4 (7.8) |
  Herpes zoster | 16/452.5 (3.5) | 0 | 14/241.2 (5.8) | 1/242.2 (0.4) | 1/104.1 (1.0) | 0 |
  Bronchitis | 14/450.5 (3.1) | 0 | 11/244.9 (4.5) | 3/244.9 (1.2) | 2/104.2 (1.9) | 0 |
  Nasopharyngitis | 14/449.1 (3.1) | 0 | 9/253.6 (3.5) | 0 | 9/98.4 (9.1) | 0 |
  Sinusitis | 12/453.2 (2.6) | 1/453.2 (0.2) | 7/252.3 (2.8) | 0 | 3/102.7 (2.9) | 1/102.7 (1.0) |
  Cellulitis | 10/467.8 (2.1) | 2/467.8 (0.4) | 3/262.6 (1.1) | 0 | 2/103.5 (1.9) | 0 |
  Influenza | 8/469.0 (1.7) | 0 | 3/266.0 (1.1) | 1/266.0 (0.4) | 0 | 0 |
  Sepsis | 8/480.3 (1.7) | 8/480.3 (1.7) | 4/267.4 (1.5) | 4/267.4 (1.5) | 2/104.0 (1.9) | 1/104.0 (1.0) |
  Tooth abscess | 7/476.3 (1.5) | 1/476.3 (0.2) | 4/261.3 (1.5) | 0 | 0 | 0 |
  Oral herpes | 6/469.8 (1.3) | 0 | 2/269.1 (0.7) | 0 | 2/103.2 (1.9) | 0 |
  Skin infection | 5/469.8 (1.1) | 0 | 3/269.5 (1.1) | 0 | 1/104.4 (1.0) | 0 |
  Viral infection | 5/471.2 (1.1) | 0 | 2/265.4 (0.8) | 0 | 0 | 0 |
  Viral gastroenteritis | 4/470.6 (0.9) | 0 | 1/270.1 (0.4) | 0 | 2/103.5 (1.9) | 0 |
  Diverticulitis | 4/475.0 (0.8) | 1/475.0 (0.2) | 3/268.5 (1.1) | 1/268.5 (0.4) | 2/103.6 (1.9) | 0 |
  Ear infection | 4/473.3 (0.8) | 0 | 4/267.8 (1.5) | 0 | 0 | 0 |
  Fungal infection | 4/479.4 (0.8) | 0 | 2/267.6 (0.7) | 1/267.6 (0.4) | 2/103.8 (1.9) | 0 |
  Localized infection | 4/479.1 (0.8) | 0 | 1/269.2 (0.4) | 1/269.2 (0.4) | 1/104.1 (1.0) | 0 |
  Lower respiratory tract infection | 4/476.9 (0.8) | 0 | 1/270.5 (0.4) | 0 | 2/103.3 (1.9) | 1/103.3 (1.0) |
  Septic shock | 2/484.6 (0.4) | 2/484.6 (0.4) | 3/270.5 (1.1) | 3/270.5 (1.1) | 0 | 0 |
 Neoplasms |  |  |  |  |  |  |
  Basal cell carcinoma | 12/450.9 (2.7) | 2/450.9 (0.4) | 10/252.7 (4.0) | 2/252.7 (0.8) | 4/103.7 (3.9) | 0 |
  Squamous cell carcinoma | 10/462.6 (2.2) | 2/462.6 (0.8) | 10/252.0 (4.0) | 3/252.0 (1.2) | 4/102.9 (3.9) | 0 |
  Squamous cell carcinoma of the skin | 9/470.2 (1.9) | 3/470.2 (0.6) | 3/266.4 (1.1) | 1/266.4 (0.4) | 1/104.7 (1.0) | 0 |
  Acute myeloid leukemia | 5/483.8 (1.0) | 5/483.8 (1.0) | 5/270.1 (1.9) | 5/270.1 (1.9) | 0 | 0 |