TABLE 5

Drug-related TEAEs in ≥2% of patients (ITT population)

Preferred term by SOCaNo. (%) of patients with eventsb (total n = 103)
Blood and lymphatic system disorders6 (5.8)
    Leukopenia4 (3.9)
    Thrombocytopenia3 (2.9)
Cardiac disorders4 (3.9)
    Tachycardia3 (2.9)
Gastrointestinal disorders28(27.2)
    Diarrhea4 (3.9)
    Nausea26 (25.2)
    Vomiting8 (7.8)
Infections and infestations3 (2.9)
    Fungal infection3 (2.9)
Investigations10 (9.7)
    Alanine aminotransferase increased4 (3.9)
    Asparate aminotransferase increased5 (4.9)
Nervous system disorders36 (35.0)
    Dizziness5 (4.9)
    Headache32 (31.1)
Skin and subcutaneous tissue disorders11 (10.7)
    Pruritus6 (5.8)
  • a SOC, system organ class.

  • b Although a patient may have had 2 or more TEAEs, the patient was counted only once within an SOC category. The same patient may have contributed to 2 or more preferred terms in the same SOC category.