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. 2021 Sep 20;23(6):537–548. doi: 10.1007/s40272-021-00469-9

Table 1.

Selected grade 3 and 4 adverse events reported with dinutuximab beta short-term infusion (100 mg/m2 given over 8 h for 5 days) and long-term infusion (100 mg/m2 given over 10 days) in patients with high-risk neuroblastoma in the SIOPEN studies [11]

Selected grade 3/4 adverse events, % Dinutuximab beta STI Dinutuximab beta LTI
Alone (n = 186a) + IL-2 (n = 192a) Alone (n = 171a) + 50% IL-2b (n = 150a)
Immunotherapy-related pain 16 26 7 18
Fever 14 40 13 29
Hypersensitivity reaction 10 20 3 3
Capillary leak syndrome 4 15 4 8
Diarrhoea 7 21 11 12
Neurotoxicity
 Central 2 6 1 1
 Peripheral 1 2 1 1
AST/ALT 17 23 21 26
Haematological toxicities
 Haemoglobin 42 66 53 66
 White blood cells 26 36 32 33
 Granulocytes 33 58 43 67
 Platelets 34 61 33 51
Hypotension 7 17 2 3
Infection 26 34 32 33
General condition 16 41 16 21

ALT alanine aminotransferase, AST aspartate aminotransferase, IL-2 interleukin 2, LTI long-term infusion, SIOPEN International Society of Paediatric Oncology European Neuroblastoma, STI short-term infusion

aNot all patients were evaluable for each adverse event

bHalf the dose administered in the STI study (3 × 106 IU/m2/day rather than 6 × 106 IU/m2/day)