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Table 1 Incidence of new-onset all-grade 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

43/148.5 (29.0)

14/92.0 (15.2)

10/65.5 (15.3)

5/45.0 (11.1)

7/21.0 (33.3)

 Diarrhea

41/147.5 (27.8)

6/89.0 (6.7)

7/65.0 (10.8)

5/46.5 (10.8)

3/20.5 (14.6)

 Ecchymosis

31/146.0 (21.2)

10/96.0 (10.4)

4/70.0 (5.7)

1/55.0 (1.8)

1/25.0 (4.0)

 Dyspnea

28/146.0 (19.2)

10/98.5 (10.2)

2/70.0 (2.9)

2/54.5 (3.7)

3/25.0 (12.0)

 Dizziness

26/144.0 (18.1)

10/96.0 (10.4)

2/66.5 (3.0)

1/49.5 (2.0)

1/21.5 (4.7)

 Pain in extremity

26/144.5 (18.0)

6/97.0 (6.2)

3/71.0 (4.2)

2/51.5 (3.9)

1/21.5 (4.7)

 Peripheral edema

26/145.5 (17.9)

7/99.5 (7.0)

8/75.0 (10.7)

3/53.5 (5.6)

2/23.0 (8.7)

 Headache

24/144.5 (16.6)

5/99.0 (5.1)

3/75.0 (4.0)

4/58.0 (6.9)

4/26.0 (15.4)

 Nausea

24/144.5 (16.6)

7/102.5 (6.8)

4/79.0 (5.1)

5/61.0 (8.2)

4/27.5 (14.5)

 Constipation

21/145.0 (14.5)

10/105.0 (9.5)

8/78.5 (10.2)

4/56.5 (7.1)

4/25.0 (16.0)

 Abdominal pain

20/144.5 (13.8)

6/106.0 (5.7)

3/84.0 (3.6)

4/66.0 (6.1)

4/29.5 (13.6)

 Insomnia

20/144.5 (13.8)

7/104.5 (6.7)

3/80.0 (3.8)

1/62.5 (1.6)

1/28.0 (3.6)

 Vomiting

20/145.5 (13.7)

3/105.5 (2.8)

2/82.5 (2.4)

4/64.5 (6.2)

4/29.0 (13.8)

 Pyrexia

20/148.0 (13.5)

8/109.5 (7.3)

7/82.5 (8.5)

3/62.0 (4.8)

2/27.5 (7.3)

 Cough

19/145.0 (13.1)

14/105.5 (13.3)

3/74.5 (4.0)

4/58.5 (6.8)

4/26.0 (15.4)

 Arthralgia

17/144.0 (11.8)

6/103.0 (5.8)

6/75.5 (7.9)

6/53.5 (11.2)

3/21.5 (14.0)

 Muscle spasms

14/143.0 (9.8)

3/105.0 (2.9)

7/81.0 (8.6)

6/58.0 (10.3)

1/23.0 (4.3)

 Back pain

13/143.0 (9.1)

11/106.5 (10.3)

0

4/58.0 (6.9)

3/25.5 (11.8)

 Night sweats

13/143.0 (9.1)

3/105.5 (2.8)

3/81.5 (3.7)

1/61.5 (1.6)

4/28.0 (14.3)

 Pneumonia

13/145.0 (9.0)

7/110.0 (6.4)

3/82.5 (3.6)

3/65.0 (4.6)

5/30.5 (16.4)

 Upper respiratory tract infection

11/143.0 (7.7)

12/108.0 (11.1)

4/74.5 (5.4)

4/55.0 (7.3)

3/24.0 (12.5)

 Fall

7/143.5 (4.9)

2/111.5 (1.8)

1/87.0 (1.1)

3/68.5 (4.4)

4/30.5 (13.1)

 Musculoskeletal pain

7/143.0 (4.9)

5/112.0 (4.5)

7/85.5 (8.2)

2/62.5 (3.2)

4/29.0 (13.8)

 Pruritus

7/142.5 (4.9)

8/110.5 (7.2)

1/81.0 (1.2)

1/63.5 (1.6)

3/29.0 (10.3)

 Herpes zoster

3/143.5 (2.1)

4/115.5 (3.5)

3/87.5 (3.4)

3/66.0 (4.5)

3/29.0 (10.3)

 Squamous cell carcinoma

0

1/116.5 (0.9)

2/91.5 (2.2)

2/70.5 (2.8)

4/32.0 (12.5)

  1. *Occurring in >10% of patients in the ruxolitinib group in ≥1 yearly interval