Table 3. Adverse events (according to low-level term) reported in at least 10 patients during follow-up.

Low-level term	Patients n = 151 n (%)	Number of occurrences of the AE	AE frequency in the warnings and precautions section in the current label for EU
Diarrhea	59 (39.1%)	94	≥ 10%
Asthenia	59 (39.1%)	97	≥ 10% (fatigue)
Abdominal pain	34 (22.5%)	40	≥ 10%
Palpebral edema	34 (22.5%)	42	≥ 1 to < 10 (eyelid edema)
Anemia	32 (21.2%)	43	≥ 10%
Death NOS	30 (19.9%)	31
Cramp	29 (19.2%)	42	≥ 10% (muscle spasms and cramps)
Nausea	28 (18.5%)	37	≥ 10%
Lower limb edema	21 (13.9%)	25	≥ 10% (fluid retention and edema)
Hospitalization	20 (13.2%)	27
Impairment of general condition	17 (11.3%)	20	≥ 1 to < 10 (weakness)
Periorbital edema	14 (9.3%)	19	≥ 10%
Edema	12 (7.9%)	14	≥ 10% (fluid retention and edema)
Vomiting	11 (7.3%)	14	≥ 10%
Bowel motility disorder	10 (6.6%)	10
Neutropenia	10 (6.6%)	14	≥ 10%

NOS, not otherwise specified