Table 4 Incidence of TEAEs in ≥10 % of patients in any treatment arm
System organ class | ETN 50 mg–ETN 25 mg (n = 21) | ETN 25 mg–ACT 10 mg (n = 20) | ACT 10 mg (n = 18) | Total (N = 59) |
|---|---|---|---|---|
Skin and subcutaneous tissue disorders | ||||
Pruritus | 3 (14.3 %) | 2 (10.0 %) | 1 (5.6 %) | 6 (10.2 %) |
Alopecia | – | 4 (20.0 %) | 1 (5.6 %) | 5 (8.5 %) |
Skin exfoliation | – | 2 (10.0 %) | 1 (5.6 %) | 3 (5.1 %) |
Gastrointestinal disorders | ||||
Dry lip | – | 3 (15.0 %) | 2 (11.1 %) | 5 (8.5 %) |
Cheilitis | – | 2 (10.0 %) | 2 (11.1 %) | 4 (6.8 %) |
Chapped lips | – | 1 (5.0 %) | 2 (11.1 %) | 3 (5.1 %) |
Investigations | ||||
Alanine aminotransferase increased | 1 (4.8 %) | 2 (10.0 %) | – | 3 (5.1 %) |
Blood bilirubin increased | – | 2 (10.0 %) | – | 2 (3.4 %) |
Musculoskeletal and connective tissue disorders | ||||
Myalgia | – | – | 2 (11.1 %) | 2 (3.4 %) |
Vascular disorders | ||||
Hypertension | – | 2 (10.0 %) | – | 2 (3.4 %) |