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. 2023 Feb 16;41(2):267–275. doi: 10.1007/s10637-023-01336-9

Table 2.

Treatment-emergent related adverse events by system organ class, preferred term and worst severity; safety population treated with lisavanbulin 70 mg/m2

System Organ Class /
Preferred Term, n (%)
Phase 1 Phase 2a Total (N = 32)
Solid tumors (N = 9) Ovarian cancer (N = 11) Glioblastoma (N = 12)
Grade 1–2 Grade 3–4 Grade 1–2 Grade 3–4 Grade 1–2 Grade 3–4 Grade 1–2 Grade 3–4
All adverse events 6 (67) 2 (22) 6 (55) 3 (27) 3 (25) 1 (8) 15 (47) 6 (19)
General disorders and administration site conditions 5 (56) 0 4 (36) 0 1 (8) 0 10 (31) 0
Fatigue 4 (44) 0 4 (36) 0 1 (8) 0 9 (28) 0
Chest pain 0 0 1 (9) 0 0 0 1 (3) 0
Gait disturbance 0 0 1 (9) 0 0 0 1 (3) 0
Pyrexia 1 (11) 0 0 0 0 0 1 (3) 0
Metabolism and nutrition disorders 4 (44) 0 3 (27) 0 2 (17) 0 9 (28) 0
Decreased appetite 1 (11) 0 1 (9) 0 1 (8) 0 3 (9) 0
Hypokalaemia 1 (11) 0 1 (9) 0 1 (8) 0 3 (9) 0
Hyponatraemia 2 (22) 0 1 (9) 0 0 0 3 (9) 0
Dehydration 1 (11) 0 1 (9) 0 0 0 2 (6) 0
Gastrointestinal disorders 4 (44) 0 3 (27) 0 1 (8) 0 8 (25) 0
Diarrhoea 2 (22) 0 2 (18) 0 0 0 4 (13) 0
Abdominal pain 1 (11) 0 2 (18) 0 0 0 3 (9) 0
Nausea 1 (11) 0 1 (9) 0 1 (8) 0 3 (9) 0
Constipation 0 0 2 (18) 0 0 0 2 (6) 0
Vomiting 1 (11) 0 1 (9) 0 0 0 2 (6) 0
Abdominal distension 1 (11) 0 0 0 0 0 1 (3) 0
Flatulence 0 0 1 (9) 0 0 0 1 (3) 0
Nervous system disorders 3 (33) 1 (11) 2 (18) 0 1 (8) 0 6 (19) 1 (3)
Paraesthesia 1 (11) 0 2 (18) 0 0 0 3 (9) 0
Neuropathy peripheral 1 (11) * 1 (11) 1 (9) * 0 0 0 2 (6) * 1 (3)
Dysgeusia 0 0 0 0 1 (8) 0 1 (3) 0
Neuralgia 1 (11) 0 0 0 0 0 1 (3) 0
Presyncope 1 (11) 0 0 0 0 0 1 (3) 0
Somnolence 1 (11) 0 0 0 0 0 1 (3) 0
Musculoskeletal and connective tissue disorders 0 0 3 (27) 0 1 (8) 0 4 (13) 0
Muscle spasms 0 0 3 (27) 0 1 (8) 0 4 (13) 0
Arthralgia 0 0 1 (9) 0 0 0 1 (3) 0
Muscle tightness 0 0 1 (9) 0 0 0 1 (3) 0
Psychiatric disorders 0 0 3 (27) 0 1 (8) 0 4 (13) 0
Hallucination 0 0 1 (9) 0 1 (8) 0 2 (6) 0
Insomnia 0 0 2 (18) 0 0 0 2 (6) 0
Confusional state 0 0 1 (9) 0 0 0 1 (3) 0
Investigations 0 0 0 1 (9) 1 (8) 1 (8) 1 (3) 2 (6)
Troponin T increased 0 0 0 0 2 (17) 0 2 (6) 0
Alanine aminotransferase increased 0 0 1 (9) 0 0 0 1 (3) 0
Aspartate aminotransferase increased 0 0 0 1 (9) 0 0 0 1 (3)
Lymphocyte count decreased 0 0 0 0 0 1 (8) 0 1 (3)
Platelet count decreased 0 0 0 0 1 (8) 0 1 (3) 0
Vascular disorders 0 1 (11) 0 2 (18) 0 0 0 3 (9)
Hypertension 0 0 0 2 (18) 0 0 0 2 (6)
Hypotension 0 1 (11) 0 0 0 0 0 1 (3)
Respiratory, thoracic and mediastinal disorders 0 0 2 (18) 0 0 0 2 (6) 0
Cough 0 0 1 (9) 0 0 0 1 (3) 0
Dyspnoea 0 0 1 (9) 0 0 0 1 (3) 0
Eye disorders 0 0 1 (9) 0 0 0 1 (3) 0
Vision blurred 0 0 1 (9) 0 0 0 1 (3) 0
Infections and infestations 1 (11) 0 0 0 0 0 1 (3) 0
Lip infection 1 (11) 0 0 0 0 0 1 (3) 0
Injury, poisoning and procedural complications 1 (11) 0 0 0 0 0 1 (3) 0
Vascular access complication 1 (11) 0 0 0 0 0 1 (3) 0
Skin and subcutaneous tissue disorders 1 (11) 0 0 0 0 0 1 (3) 0
Hyperhidrosis 1 (11) 0 0 0 0 0 1 (3) 0
Preferred terms (PTs) are coded according to MedDRA Version 19.0. ‘Related’ means possibly or probably related. A patient with multiple events within a PT is counted only once in the PT; the worst CTCAE grade is counted. * Peripheral sensory neuropathy.