Table 3 Adverse events in patients in the safety data set.

	Grade 1–4		Grade 3/4
	Topotecan (n = 81)	Belotecan (n = 80)	Topotecan (n = 81)	Belotecan (n = 80)
Summary, n (% of subgroup population)
AEs
RDI: ≥85%	37 (100%)	40 (100%)	30 (81%)	33 (83%)
RDI: <85%	43 (98%)	39 (98%)	40 (91%)	34 (85%)
Serious AEs^a
RDI: ≥85%	17 (46%)	18 (45%)	16 (43%)	15 (38%)
RDI: <85%	26 (59%)	15 (38%)	25 (57%)	14 (35%)
	p = 0.048^b		p = 0.045^b
SOC^c, n (% of group population)
Investigations
Neutropenia	67 (83%)	61 (76%)	59 (73%)	54 (68%)
Thrombocytopenia	43 (53%)	33 (41%)	36 (44%)	29 (36%)
Leukocytopenia	20 (25%)	18 (23%)	18 (22%)	16 (20%)
Blood and lymphatic system
Anaemia	44 (54%)	37 (46%)	20 (25%)	22 (28%)
Febrile neutropenia^d	1 (1%)	4 (5%)	1 (1%)	4 (5%)
Metabolism and nutrition
Anorexia	36 (44%)	32 (40%)	3 (4%)	0 (0%)
Gastrointestinal system
Nausea	30 (37%)	35 (44%)	1 (1%)	2 (2%)
Constipation	16 (20%)	18 (23%)	0 (0%)	0 (0%)
Vomiting	10 (12%)	14 (18%)	1 (1%)	1 (1%)
Diarrhoea	9 (11%)	12 (15%)	2 (3%)	1 (1%)
Abdominal pain	7 (9%)	10 (13%)	0 (0%)	0 (0%)
Mucositis oral	7 (9%)	10 (13%)	0 (0%)	0 (0%)
Respiratory, thoracic and mediastinal system
Dyspnoea	20 (25%)	14 (18%)	3 (4%)	4 (5%)
Cough	9 (11%)	16 (20%)	0 (0%)	0 (0%)
Productive cough	9 (11%)	8 (10%)	1 (1%)	0 (0%)
General and administration site conditions
Fatigue	20 (25%)	18 (23%)	3 (4%)	1 (1%)
Pain	10 (12%)	11 (14%)	0 (0%)	0 (0%)
Fever	8 (10%)	11 (14%)	0 (0%)	0 (0%)
Nervous system
Dizziness	13 (16%)	14 (18%)	1 (1%)	1 (1%)
Headache	10 (12%)	8 (10%)	0 (0%)	0 (0%)
Skin and subcutaneous tissue
Alopecia	12 (15%)	8 (10%)	0 (0%)	0 (0%)

AE adverse event, RDI relative dose intensity, SOC system organ class.
^aSerious AEs: when the patient outcome is death, life-threatening, hospitalisation (initial or prolonged), or disability or permanent damage, in accordance with FDA guidelines.
^bp value was obtained using Chi-square test, p < 0.05 indicates that in patients with RDI < 85%, belotecan resulted in significantly fewer serious AEs than topotecan.
^cOnly common (≥10%) AEs are presented.
^dFebrile neutropenia: absolute neutrophil count <1000 per mm³ and fever ≥38.5 °C. Grade 3/4 febrile neutropenia-associated hospitalisation/prolonged hospitalisation occurred in 1 and 3 patients in the topotecan and belotecan groups, respectively.

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