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 AEsa | ||||
| RDI: ≥85% | 17 (46%) | 18 (45%) | 16 (43%) | 15 (38%) |
| RDI: <85% | 26 (59%) | 15 (38%) | 25 (57%) | 14 (35%) |
| p = 0.048b | p = 0.045b | |||
| SOCc, 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 neutropeniad | 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.