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A.L. Sørensen et al.
artery occlusion and multiple small pulmonary emboli in one PV patient. Grade 1 or 2 hematologic adverse events, and grade 3 anemia in patients with MF, were frequent. We only recorded a few other grade 3 or 4 hematologic adverse events. With regards to non-hematologic adverse events, fatigue, influenza-like symptoms, pruritus, upper airway infection, joint pain, muscle pain, and elevated lac- tate dehydrogenase were observed in ≥30% of patients.
Six (12%) patients had grade 3 or 4 pneumonia, and one (2%) had a grade 3 or 4 urinary tract infection. Two (4%) patients had herpes zoster infection grade 1 or 2. In 11 (22%) patients, mood alterations, including depressive symptoms, agitation, anxiety, and memory impairment, were observed. No autoimmune thyroiditis occurred in our study, but one patient was diagnosed with Sjögren syndrome. All the drug-related adverse events are known
Table 2. Adverse events reported in ≥ 10% of patients and all grade 3 or 4 adverse events.
Drop-outs, n (%)
Total discontinuation of PEG-IFNa2, n (%) Adverse events
Hematologic, n (%)
Anemia
Thrombocytopenia
Leukopenia
Non-hematologic, n (%)
Cardiac ischemia Palpitations
Arterial hypertension Pulmonary embolism Fatigue
Night sweats
Influenza-like symptomsb Fever
Pruritus
Local injection site reactionsb Dyspepsia
Nausea
Abdominal pain Gastrointestinal bleedingc Upper airway infection Pneumonia
Urinary tract infection
Weight gain
Joint pain
Muscle pain
Mood alterationd
Neuropathy: sensory Dizziness
CNS ischemiae
Syncope
Headache
Dyspnea
Acute renal failure Proteinuria
Benign bladder tumor Elevated alanine transaminase
Elevated lactate dehydrogenase
Overall (n=50) 8 (16%) 17 (34%)
Polycythemia vera (n=32)
2 (6%)
10 (31%)
Grade 1–2, Grade 3–4,
Myelofibrosis (n=18) 6 (32%)
7 (39%)
a
Grade 1–2, Grade 3–4,
N.(%) N.(%) N.(%) N.(%) N.(%) N.(%)
Grade 1–2,
Grade 3–4,
38 (76.0)
12 (24.0) 22 (44)
0 (0.0) 5 (10.0) 2 (4.0) 0 (0.0) 23 (46.0) 14 (28.0) 15 (30.0) 9 (18.0) 20 (40.0) 10 (20.0) 6 (12.0) 14 (28.0) 6 (12.0) 0 (0.0) 23 (46.0) 3 (6.0) 4 (8.0) 7 (14.0) 19 (38.0) 21 (42.0) 11 (22.0) 12 (24.0) 11 (22.0) 0 (0.0) 0 (0.0) 12 (24.0) 8 (16.0) 0 (0.0) 0 (0.0) 0 (0.0) 7 (14.0)
17 (34.0)
7 (14.0)
2 (4.0) 1 (2.0)
1 (2.0) 0 (0.0) 3 (6.0) 1 (2.0) 1 (2.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 (6.0) 0 (0.0) 6 (12.0) 1 (2.0) 0 (0.0) 2 (4)
1 (2.0)
0 (0.0)
0 (0.0)
0 (0.0)
2 (3.8)
1 (2.0)
0 (0.0)
0 (0.0)
1 (2.0)
1 (2.0)
1 (2.0)
0 (0.0)
0 (0.0)
23 (71.9)
9 (28.1) 15 (46.9)
0 (0.0) 1 (5.6) 2 (6.2) 0 (0.0) 15 (46.9) 10 (31.2) 11 (34.4) 6 (18.8) 17 (53.1) 6 (18.8) 3 (9.4)
9 (28.1)
3 (9.4)
0 (0.0)
15 (46.9)
3 (9.4)
2 (6.2)
5 (15.6)
14 (43.8)
16 (50.0)
8 (25.0)
7 (21.9)
6 (18.8)
0 (0.0)
0 (0.0)
7 (21.9)
5 (15.6)
0 (0.0)
0 (0.0)
0 (0.0)
6 (18.8)
12 (37.5)
1 (3.1)
2 (6.2) 1 (3.1)
1 (3.1) 0 (0.0) 3 (9.4) 1 (3.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 5 (15.6) 0 (0.0) 0 (0.0) 2 (6.2) 1 (3.1) 0 (0.0) 0 (0.0) 0 (0.0) 1 (3.1) 1 (3.1) 0 (0.0) 0 (0.0) 1 (3.1) 1 (3.1) 1 (3.1) 0 (0.0) 0 (0.0)
15 (83.3)
3 (16.7) 7 (38.9)
0 (0.0) 4 (12.5) 0 (0.0) 0 (0.0) 8 (44.4) 4 (22.2) 4 (22.2) 3 (16.7) 3 (16.7) 4 (22.2) 3 (16.7) 5 (27.8) 3 (16.7) 0 (0.0) 8 (44.4) 0 (0.0) 2 (11.1) 2 (11.1) 5 (27.8) 5 (27.8) 3 (16.7) 5 (27.8) 5 (27.8) 0 (0.0) 0 (0.0) 5 (27.8) 3 (16.7) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 5 (26.3)
6 (33.3)
0 (0.0) 0 (0.0)
0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 (16.7) 0 (0.0) 1 (5.6) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). aThe total number includes patients who dropped out of the study. bRelated to pegylated interferon-a2 treatment. cOne patient had esophageal varices with bleeding, one had Mallory Weiss lesions, and one had rectal bleeding. dFive patients had depressive symptoms, three experienced agitation, two anxiety, and two had memory impairment while one had both anxiety and memory impair- ment. eOne patient had an ischemic stroke and a retinal artery occlusion. PEG-IFNa2: peglylated interferon-a2; CNS: central nervous system
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haematologica | 2020; 105(9)