Table 2.

Treatment-emergent adverse events by preferred term (safety analysis set).

Treatment-emergent adverse events (≥20% in any group) by preferred term
Preferred term, n (%)Alpelisib (n = 16)Buparlisib (n = 13)
Patients with at least 1 TEAE16 (100)13 (100)
 Rash7 (43.8)8 (61.5)
 Decreased appetite9 (56.3)4 (30.8)
 Stomatitis6 (37.5)6 (46.2)
 Nausea6 (37.5)3 (23.1)
 Hyperglycemia5 (31.3)6 (46.2)
 Alopecia7 (43.8)2 (15.4)
 Hot flush7 (43.8)1 (7.7)
 Diarrhea6 (37.5)2 (15.4)
 Fatigue5 (31.3)3 (23.1)
 ALT increased2 (12.5)6 (46.2)
 Pruritus3 (18.8)5 (38.5)
 AST increased1 (6.3)6 (46.2)
 Weight decreased8 (50.0)0
 Dizziness3 (18.8)3 (23.1)
 Edema peripheral2 (12.5)2 (15.4)
 Insomnia04 (30.8)
 Arthralgia1 (6.3)2 (15.4)
 Abdominal pain upper1 (6.3)3 (23.1)
 Face edema4 (25.0)0
 Noncardiac chest pain1 (6.3)1 (7.7)
 Pain in extremity2 (12.5)0
 Hypertension1 (6.3)3 (23.1)
 Anemia1 (6.3)0
 Neutrophil count decreased01 (7.7)
Treatment-emergent adverse events of grade 3 or grade 4 (≥5% in any group) by preferred term
Patients with at least 1 ≥ grade 3 TEAE8 (50)10 (76.9)
 ALT increased04 (30.8)
 AST increased03 (23.1)
 Hypokalemia2 (12.5)1 (7.7)
 Hyperglycemia1 (6.3)1 (7.7)
 Anxiety02 (15.4)
 Rash1 (6.3)1 (7.7)
  • Note: TEAEs were defined as events that started or worsened after the first administration of the study treatment until the date of last dose of study treatment + 28 days. Patients with multiple occurrences of TEAE under a treatment were counted only once in the TEAE category for that treatment. Patients with multiple TEAEs within a PT were counted only once for that PT; PTs are presented in descending order of frequency overall among TEAEs of at least grade 1. Percentages were calculated using the SAF as the denominator.

  • Abbreviations: PT, preferred term; SAF, safety analysis set.