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. 2020 Nov 4;15(11):e0241267. doi: 10.1371/journal.pone.0241267

Table 2. Adverse events and treatment-related adverse events occurring in ≥ 2.5% of patients (N = 41).

Adverse event n (%)
Any AE 21 (51.2)
Any SAE 0 (0)
AEs leading to discontinuation 0 (0)
AEs occurring in ≥ 2 patients
    Nausea 6 (14.6)
    Dizziness / vertigo 3 (7.3)
    Anemia 2 (4.9)
    Abdominal pain 2 (4.9)
    Emesis 2 (4.9)
    Epigastric pressure pain 2 (4.9)
    Flu like symptoms 2 (4.9)
    FSS increased ≥ 1 2 (4.9)
    Total bilirubin increase 2 (4.9)
Any treatment-related AE 13 (31.7)
Treatment-related AEs occurring in ≥ 2 patients
    Nausea 4 (9.8)
    Total bilirubin increase 2 (4.9)
    Anemia 2 (4.9)
    FSS increased ≥ 1 2 (4.9)

AE = adverse event; FSS = fatigue severity scale: SAE = serious adverse event.

Fatigue is not included as it was part of the inclusion criteria. An increase of ≥ 1 point in the FSS was documented as an AE.

Any AE occurred in 21 out of 41 patients (51.2%).