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Table 2 Incidence of new-onset grade 3 or 4 nonhematologic adverse events in the ruxolitinib group regardless of causality, grouped by treatment time interval

From: Long-term treatment with ruxolitinib for patients with myelofibrosis: 5-year update from the randomized, double-blind, placebo-controlled, phase 3 COMFORT-I trial

 

Ruxolitinib (n = 155)

0– < 12 Months

12– < 24 Months

24– < 36 Months

36– < 48 Months

≥48 Months

Event,*n/N (%)

 Fatigue

9/144.5 (6.2)

1/113.0 (0.9)

3/90.0 (3.3)

1/69.5 (1.4)

0

 Pneumonia

8/144.0 (5.6)

4/112.0 (3.6)

3/86.0 (3.5)

2/67.5 (3.0)

5/32.0 (15.6)

 Abdominal pain

6/143.5 (4.2)

0

3/93.5 (3.2)

1/72.5 (1.4)

1/32.0 (3.1)

 Arthralgia

3/142.5 (2.1)

0

0

1/70.0 (1.4)

0

 Diarrhea

3/143.5 (2.1)

0

0

1/72.5 (1.4)

0

 Dyspnea

3/143.5 (2.1)

1/116.5 (0.9)

2/92.5 (2.2)

1/71.5 (1.4)

1/31.5 (3.2)

 Pain in extremity

3/142.5 (2.1)

0

1/89.5 (1.1)

1/69.5 (1.4)

1/30.5 (3.3)

 Acute myeloid leukemia

2/143.5 (1.4)

0

1/93.0 (1.1)

2/74.0 (2.7)

0

 Fall

2/142.5 (1.4)

1/114.5 (0.9)

0

2/71.0 (2.8)

1/30.5 (3.3)

 Gastrointestinal hemorrhage

2/142.5 (1.4)

1/115.0 (0.9)

0

0

0

 Hyperuricemia

2/142.5 (1.4)

1/114.5 (0.9)

0

1/71.5 (1.4)

0

 Hypoxia

2/142.5 (1.4)

0

2/92.0 (2.2)

0

1/31.5 (3.2)

 Muscular weakness

2/143.0 (1.4)

0

1/91.5 (1.1)

0

0

 Septic shock

2/143.5 (1.4)

0

0

0

0

 Acute renal failure

1/142.5 (0.7)

1/116.0 (0.9)

3/93.0 (3.2)

2/72.5 (2.8)

1/31.5 (3.2)

 Back pain

1/142.5 (0.7)

2/116.0 (1.7)

0

0

0

 Congestive cardiac failure

1/142.5 (0.7)

0

1/92.0 (1.1)

0

2/32.5 (6.2)

 Epistaxis

1/143.0 (0.7)

2/117.0 (1.7)

0

0

0

 Sepsis

1/143.0 (0.7)

2/116.5 (1.7)

2/92.5 (2.2)

1/73.0 (1.4)

2/32.5 (6.2)

 Upper abdominal pain

1/143.0 (0.7)

0

2/92.5 (2.2)

0

0

 Cellulitis

0

0

0

2/73.5 (2.7)

0

 Myocardial infarction

0

1/117.0 (0.9)

0

2/73.5 (2.7)

0

 Osteoarthritis

0

0

1/92.5 (1.1)

0

2/32.5 (6.2)

 Osteomyelitis

0

0

0

2/73.0 (2.7)

0

 Squamous cell carcinoma

0

1/116.5 (0.9)

0

0

2/32.5 (6.2)

 Urinary tract infection

0

1/116.5 (0.9)

1/92.0 (1.1)

0

2/33.0 (6.1)

 Wound infection

0

0

0

0

2/33.0 (6.1)

  1. *Occurring in ≥2 patients in the ruxolitinib group in any yearly interval