Table 2 TEAEs in ≥10% of patients in either treatment arm

From: Pelabresib plus ruxolitinib for JAK inhibitor-naive myelofibrosis: a randomized phase 3 trial

Adverse events

Pelabresib + ruxolitinib

(N = 212)a

Placebo + ruxolitinib

(N = 214)a

All grades

Grade ≥ 3

All grades

Grade ≥ 3

Hematological events, no. patients (%)

 Thrombocytopeniab

112 (52.8)

28 (13.2)

80 (37.4)

13 (6.1)

 Anemiac

95 (44.8)

49 (23.1)

118 (55.1)

78 (36.5)

Nonhematological events, no. patients (%)

 Diarrhea

49 (23.1)

1 (0.5)

39 (18.2)

3 (1.4)

 Dysgeusia

39 (18.4)

1 (0.5)

8 (3.7)

0

 Constipation

39 (18.4)

0

52 (24.3)

0

 Nausea

30 (14.2)

1 (0.5)

32 (15.0)

0

 Cough

27 (12.7)

0

24 (11.2)

0

 Asthenia

25 (11.8)

1 (0.5)

30 (14.0)

0

 Fatigue

25 (11.8)

1 (0.5)

35 (16.4)

2 (0.9)

 Dizziness

24 (11.3)

0

19 (8.9)

0

 Headache

24 (11.3)

1 (0.5)

23 (10.7)

0

 COVID-19

24 (11.3)

0

34 (15.9)

4 (1.9)

 Muscle spasms

24 (11.3)

0

9 (4.2)

0

 Dyspnea

19 (9.0)

1 (0.5)

28 (13.1)

3 (1.4)

 Arthralgia

17 (8.0)

0

24 (11.2)

0

  1. TEAEs reported in ≥10% of patients in either treatment arm who received at least one dose of treatment.
  2. aSafety population includes all patients who received at least one dose of study drug.
  3. b‘Thrombocytopenia’ includes preferred terms of thrombocytopenia and platelet count decrease.
  4. c‘Anemia’ includes preferred terms of anemia and hemoglobin decrease. A TEAE for the double-blinded treatment period is defined as an adverse event that has a start date on or after the first dose of pelabresib/placebo and before 30 days after the last dose of pelabresib/placebo or before the start of alternative (off-study) treatment for myelofibrosis, whichever occurs first. For any adverse event for which Common Terminology Criteria for Adverse Events grading does not exist, the investigator assessed severity using the WHO grading system, in which grades 1–4 correspond to the severity of mild, moderate, severe and life-threatening.
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