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. | ||||||||