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%).