Table 14.3.1 Treatment-Emergent Adverse Events by SOC and Preferred Term
ONC-2024-001 | Safety Population (N=120)
MedDRA SOC Preferred Term Any grade, n (%) Grade >=3, n (%)
ANY TEAE -- Any preferred term -- 117 (97.5) 65 (54.2)
Gastrointestinal disorders Nausea 52 (43.3) 14 (11.7)
Gastrointestinal disorders Diarrhoea 51 (42.5) 11 (9.2)
Investigations Alanine aminotransferase increased 42 (35.0) 8 (6.7)
General disorders and administration site conditions Fatigue 38 (31.7) 9 (7.5)
Investigations Blood creatine phosphokinase increased 33 (27.5) 9 (7.5)
Investigations Aspartate aminotransferase increased 31 (25.8) 6 (5.0)
Nervous system disorders Headache 30 (25.0) 10 (8.3)
Respiratory, thoracic and mediastinal disorders Cough 27 (22.5) 5 (4.2)
Vascular disorders Hypertension 27 (22.5) 7 (5.8)
Skin and subcutaneous tissue disorders Rash 23 (19.2) 3 (2.5)
Gastrointestinal disorders Vomiting 21 (17.5) 7 (5.8)
Respiratory, thoracic and mediastinal disorders Pneumonitis 9 (7.5) 2 (1.7)
Subjects counted once per term at worst grade. Synthetic data.