Table 2.

Patients with adverse events of CTCAE grade 1–4 during 18 months follow-up.

	≥1	≥2	3–4*	Related to study treatment†
Patients with ≥ 1 adverse event	39 (97.5%)	33 (82.5%)	11 (27.5%)	29 (72.5%)
Nausea	36 (90%)	15 (37.5%)	0	36 (90%)
Constipation	22 (55%)	9 (22.5%)	1 (2.5%)	19 (47.5%)
Diarrhea	7 (17.5%)	1 (2.5%)	0	6 (15%)
Stomach pain	9 (22.5%)	2 (5%)	1 (2.5%)	7 (17.5%)
Infections	24 (60%)	15 (37.5%)	3 (7.5%)	13 (32.5%)
Irregular menstrual bleeding	7 (17.5%)	3 (7.5%)	0	7 (17.5%)
Premature menopause	2 (5%)	1 (2.5%)	0	2 (5%)
Haematuria	6 (15%)	1 (2.5%)	0	6 (15%)
Urinary bladder symptoms**	5 (12.5%)	3 (7.5%)	0	5 (12.5%)
Hair loss	4 (10%)	0	0	4 (10%)
Rash or urticaria	6 (15%)	4 (10%)	1 (2.5%)	5 (12.5%)
Headache	12 (30%)	3 (7.5%)	1 (2.5%)	9 (22.5%)
Dizziness	6 (15%)	3 (7.5%)	0	5 (12.5%)
Edema of face or limbs	6 (15%)	0	0	5 (12.5%)
Palpitations or tachycardia	4 (10%)	2 (5%)	1 (2.5%)	2 (5%)

^*11 grade 3–4 events for 8 patients were reported as SAE. See Supplementary Table 4 for details.

^†Possible, probable or very likely relation to study treatment.

^**Bladder/urinary tract pain or increased urinary frequency.