Table 1 Treatment-emergent adverse events of anaemia in two phase II PV studies with a total of 78 patients.

From: Ropeginterferon alfa-2b shows anti-polycythaemia vera activity without causing clinically significant anaemia

PV Study

Anaemia

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Total

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

A19-201 study [7]

3 (10.3%)

1 (3.4%)a

0

0

0

4 (13.7%)

A20-202 study [9]

8 (16.3%)

3 (6.1%)

0

0

0

11 (22.4%)

  1. Anaemia was graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0). Grade 1: haemoglobin (Hgb) lower limit of normal (LLN) to 10 g/dL; Grade 2: Hgb 8–10 g/dL; Grade 3: Hgb < 8 g/dL; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death.
  2. aGrade 2 anaemia was noted during the safety follow-up after the discontinuation of treatment in one patient.
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