Table 3

Summary of adverse events (AEs) occurring in more than 4% of patients

AEAny AETEAEDiscontinued
System organ class/preferred termPatientsEventsPatientsEventsPatientsEvents
Total7517658116
Gastrointestinal disorders313927351012
 Diarrhoea2122192066
 Nausea666633
General disorders and administration site conditions993322
 Fatigue6611
Infections and infestations121733
Investigations8989
 Increased alanine aminotransferase4444
Musculoskeletal and connective tissue disorders781111
Nervous system disorders2733141977
 Paraesthesia7744
 Headache444411
Psychiatric disorders4523
Skin and subcutaneous tissue disorders2629252866
 Alopecia2323232344
 Rash222222
Vascular disorders8855
 Hypertension6655
  • TEAE, treatment-emergent AE (treatment related).