Table 3:
Summary of the safety profile of tazemetostat in the modified intention-to-treat population (n=99)
| Treatment-emergent adverse events |
Treatment-related adverse events |
|||||
|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
| Nausea | 23 (23%) | 0 | 0 | 19 (19%) | 0 | 0 |
| Diarrhoea | 18 (18%) | 0 | 0 | 12 (12%) | 0 | 0 |
| Alopecia | 17 (17%) | 0 | 0 | 14 (14%) | 0 | 0 |
| Cough | 16 (16%) | 0 | 0 | 2 (2%) | 0 | 0 |
| Asthenia | 15 (15%) | 3 (3%) | 0 | 13 (13%) | 1 (1%) | 0 |
| Fatigue | 15 (15%) | 2 (2%) | 0 | 11 (11%) | 1 (1%) | 0 |
| Upper respiratory tract infection | 15 (15%) | 0 | 0 | 1 (1%) | 0 | 0 |
| Bronchitis | 15 (15%) | 0 | 0 | 3 (3%) | 0 | 0 |
| Abdominal pain | 12 (12%) | 1 (1%) | 0 | 2 (2%) | 0 | 0 |
| Headache | 12 (12%) | 0 | 0 | 5 (5%) | 0 | 0 |
| Vomiting | 11 (11%) | 1 (1%) | 0 | 6 (6%) | 0 | 0 |
| Back pain | 11 (11%) | 0 | 0 | 0 | 0 | 0 |
| Pyrexia | 10 (10%) | 0 | 0 | 2 (2%) | 0 | 0 |
| Anaemia | 9 (9%) | 4 (4%) | 1 (1%) | 7 (7%) | 2 (2%) | 0 |
| Thrombocytopenia | 5 (5%) | 4 (4%) | 1 (1%) | 5 (5%) | 3 (3%) | 0 |
| Neutropenia | 3 (3%) | 3 (3%) | 1 (1%) | 3 (3%) | 2 (2%) | 1 (1%) |
| Leucopenia | 2 (2%) | 1 (1%) | 0 | 2 (2%) | 1 (1%) | 0 |
| Hypophosphataemia | 2 (2%) | 1 (1%) | 0 | 2 (2%) | 1 (1%) | 0 |
| Hypertriglyceridaemia | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 1 (1%) | 0 |
| Increased serum amylase | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 1 (1%) | 0 |
| Presyncope | 0 | 1 (1%) | 0 | 0 | 1 (1%) | 0 |
| Pancytopenia | 0 | 0 | 1 (1%) | 0 | 0 | 1 (1%) |
| Increased serum aminotransferase | 0 | 1 (1%) | 0 | 0 | 1 (1%) | 0 |
| Myelodysplastic syndrome | 0 | 1 (1%) | 0 | 0 | 1 (1%) | 0 |
| Dyspnoea | 5 (5%) | 3 (3%) | 0 | 1 (1%) | 0 | 0 |
| Dizziness | 6 (6%) | 1 (1%) | 0 | 3 (3%) | 0 | 0 |
| Upper abdominal pain | 5 (5%) | 1 (1%) | 0 | 4 (4%) | 0 | 0 |
| Urinary tract infection | 5 (5%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 |
| Hypogammaglobulinaemia | 3 (3%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 |
| Hypertension | 3 (3%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Hyperkalaemia | 2 (2%) | 1 (1%) | 0 | 1 (1%) | 1 (1%) | 0 |
| Lung infection | 2 (2%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 |
| Pleural effusion | 2 (2%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Herpes zoster | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Sepsis | 0 | 0 | 2 (2%) | 0 | 0 | 0 |
| General physical health deterioration | 0 | 0 | 2 (2%) | 0 | 0 | 0 |
| Non-cardiac chest pain | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 |
| Hyperuricaemia | 1 (1%) | 0 | 1 (1%) | 1 (1%) | 0 | 0 |
| Prolonged QT interval on electrocardiogram | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 |
| Hypothyroidism | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 |
| Lymphopenia | 1 (1%) | 0 | 1 (1%) | 0 | 0 | 0 |
| Lower gastrointestinal haemorrhage | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Hypokalaemia | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Acute myeloid leukaemia | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Malignant melanoma | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Chronic kidney disease | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Bile duct obstruction | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Ascites | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Acute pancreatitis | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Empyema | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Cerebrovascular accident | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Osmotic demyelination syndrome | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Post-herpetic neuralgia | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Syncope | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Hypoxia | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Hypercalcaemia | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Hyperglycaemia | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Hyponatraemia | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Increased blood pressure | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Femoral artery occlusion | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Subclavian vein thrombosis | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Squamous cell carcinoma | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Constrictive pericarditis | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
Data are n (%) or n. We report any grade 1–2 adverse event occurring in at least 10% of patients. All grade 3 and 4 events are reported. There were no deaths due to adverse events.