Table 1 Summary of all adverse events in PROUD-PV and CONTINUATION-PV (Safety set).
From: Long-term outcomes of polycythemia vera patients treated with ropeginterferon Alfa-2b
Ropeginterferon alfa-2b | Control | ||||
|---|---|---|---|---|---|
(499 patient years) | (401 patient years) | ||||
Type of event | Intensity grade | Adverse events | Number of patientsa | Adverse events | Number of patientsa |
n (%) | n (%) | ||||
N = 127 | N = 127 | ||||
Adverse events | 1767 | 116 (91.3%) | 1267 | 117 (92.1%) | |
Serious adverse events | 56 | 30 (23.6%) | 56 | 32 (25.2%) | |
Treatment-related serious adverse events | 4 | 4 (3.1%) | 7 | 5 (3.9%) | |
Adverse events related to polycythemia vera | 171 | 48 (37.8%) | 135 | 48 (37.8%) | |
Treatment-related adverse events | 758 | 100 (78.7%) | 458 | 100 (78.7%) | |
Intensity of treatment-related adverse eventsb | Grade 1 | 477 | 73 (57.5%) | 277 | 79 (62.2%) |
Grade 2 | 241 | 75 (59.1%) | 152 | 62 (48.8%) | |
Grade 3 | 39 | 21 (16.5%) | 28 | 20 (15.7%) | |
Grade 4 | 1 | 1 (0.8%) | 0 | 0 | |
Grade 5 | 0 | 0 | 1 | 1 (0.8%) | |
Grade ≥3 | 40 | 21 (16.5%) | 29 | 21 (16.5%) | |
Treatment-related adverse events leading to discontinuation | 15 | 13 (10.2%) | 4 | 4 (3.1 %) | |
Disease progression (myelofibrosis and leukemic transformation)c | 1 | 1 (0.8%) | 4 | 4 (3.1%) | |
Any neoplasm | 16 | 12 (9.4%) | 18 | 15 (11.8%) | |
Skin cancers related to treatment (basal cell carcinoma and malignant melanoma) | 0 | 0 | 3 | 3 (2.4%) | |
Major thromboembolic adverse eventsd | 5 | 4 (3.1%) | 5 | 5 (3.9 %) | |
