Table 2.

Most frequently observed treatment-emergent adverse eventsa

Cohort 1 (N = 6)2 mg Taselisib QD 21d, 7d off+ 20 mg tamoxifenCohort 2 (N = 13)4 mg Taselisib QD 21d, 7d off+ 20 mg tamoxifenCohort 3 (N = 11)4 mg Taselisib continuous+ 20 mg tamoxifenAll patients (N = 30)
Grade 1–2Grade 3–4Grade 1–2Grade 3–4Grade 1–2Grade 3–4Grade 1–2Grade 3–4
AST/ALT/GGT increase1 (17%)05 (38%)3 (23%)4 (36%)010 (33%)3 (10%)
Diarrhea/colitis2 (33%)1 (17%)5 (38%)1 (8%)3 (27%)1 (9%)10 (33%)3 (10%)
Anemia3 (50%)03 (23%)06 (54%)012 (40%)0
Mucositis, oral2 (33%)02 (15%)2 (15%)4 (36%)08 (27%)2 (7%)
Nausea2 (33%)05 (38%)02 (18%)09 (30%)0
Hyperglycemia003 (23%)04 (36%)1 (9%)7 (23%)1 (3%)
Lipase/amylase increase1 (17%)02 (15%)2 (15%)1 (9%)2 (18%)4 (13%)4 (13%)
Fatigue003 (23%)04 (36%)07 (23%)0
Headache1 (17%)05 (38%)01 (9%)07 (23%)0
Thrombocytopenia1 (17%)03 (23%)1 (8%)1 (9%)05 (17%)1 (9%)
Alopecia004 (31%)01 (9%)05 (17%)0
Weight loss1 (17%)01 (8%)03 (27%)05 (17%)0
Abdominal pain1 (17%)01 (8%)02 (18%)04 (13%)0
Creatinine increase003 (23%)01 (9%)04 (13%)0
Triglyceride increase002 (15%)01 (9%)1 (9%)3 (10%)1 (3%)
Pneumonitis0001 (8%)0001 (3%)
Any AE4 (67%)1 (17%)5 (38%)8 (62%)6 (54%)5 (45%)15 (50%)14 (47%)
  • Abbreviations: AE, adverse event; AST, aspartate transaminase; ALT, alanine transaminase; GGT, gamma-glutamyltransaminase; QD, once daily.

  • aHighest grade of AEs occurring at any time point, in at least 10% of patients, and thought to be at least possibly study–drug related.