Table 1 Baseline characteristics and pretreatment of CML patients.

From: Randomized phase 3 trial of Ropeginterferon alfa-2b versus surveillance after tyrosine kinase inhibitor discontinuation in chronic myeloid leukemia (ENDURE/CML-IX)

WHO grade 3 and 4 adverse events, n (%)

Ropeg-IFN (n = 94a)

Surveillance (n = 108)

Grade 3

Grade 4

Grade 3

Grade 4

Neutropenia

3 (3.2)

-

1 (0.9)

-

Pain (bone, joint and skeletal, head, general)

5 (5.3)

-

6 (5.6)

-

Myalgia

-

-

2 (1.9)

-

Hypertriglyceridemia

2 (2.1)

1 (1.1)

1 (0.0)

 

Liver enzyme elevation

1 (1.1)

1 (1.1)

-

-

Gastrointestinal toxicity (nausea, diarrhea, dry mouth)

2 (2.1)

-

1 (0.9)

 

Skin (lichen, erysipelas)

1 (1.1)

-

1 (0.9)

-

Neurological (hearing loss, PNP, insomnia, hypoasthesia)

4 (4.3)

-

1 (0.9)

 

Edema

-

-

2 (1.9)

-

Fatigue, discomfort

-

-

2 (1.9)

-

Arterial disorder and hypertension

2 (2.1)

-

7 (6.5)

-

Cardiopulmonary (pleural effusion)

2 (2.1)

-

-

-

Other (operations, bone fracture, COVID-19, hyperthyrodism, hyponatremia, adenoma, sinusitis)

6 (6.4)

-

3 (2.8)

-

Total 30 (31.9) 2 (2.1) 26 (24.1)

  1. All data are presented as no. (%) unless otherwise indicated.
  2. CML chronic myeloid leukemia, ELTS EUTOS long-term survival score, EUTOS European Treatment and Outcome Study, ropeg-IFN ropeginterferon alfa-2b, TKI tyrosine kinase inhibitor.
  3. aSafety population (patients, who received at least one time study medication).
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