AE | Any AE | TEAE | Discontinued | |||
System organ class/preferred term | Patients | Events | Patients | Events | Patients | Events |
Total | 75 | 176 | 58 | 116 | ||
Gastrointestinal disorders | 31 | 39 | 27 | 35 | 10 | 12 |
Diarrhoea | 21 | 22 | 19 | 20 | 6 | 6 |
Nausea | 6 | 6 | 6 | 6 | 3 | 3 |
General disorders and administration site conditions | 9 | 9 | 3 | 3 | 2 | 2 |
Fatigue | 6 | 6 | 1 | 1 | – | – |
Infections and infestations | 12 | 17 | 3 | 3 | – | – |
Investigations | 8 | 9 | 8 | 9 | – | – |
Increased alanine aminotransferase | 4 | 4 | 4 | 4 | – | – |
Musculoskeletal and connective tissue disorders | 7 | 8 | 1 | 1 | 1 | 1 |
Nervous system disorders | 27 | 33 | 14 | 19 | 7 | 7 |
Paraesthesia | 7 | 7 | 4 | 4 | – | – |
Headache | 4 | 4 | 4 | 4 | 1 | 1 |
Psychiatric disorders | 4 | 5 | 2 | 3 | ||
Skin and subcutaneous tissue disorders | 26 | 29 | 25 | 28 | 6 | 6 |
Alopecia | 23 | 23 | 23 | 23 | 4 | 4 |
Rash | 2 | 2 | 2 | 2 | 2 | 2 |
Vascular disorders | 8 | 8 | 5 | 5 | – | – |
Hypertension | 6 | 6 | 5 | 5 | – | – |
TEAE, treatment-emergent AE (treatment related).