Table 3.

Treatment-related AE occurring in ≥10% of patients on study

30 mg 28/28 d (n = 27)40 mg 28/28 d (n = 51)All patients in study (n = 120)
≤G2G3≥G4≤G2G3≥G4≤G2G3≥G4
Patients
 Patients with any AE related to apitolisib12 (44%)14 (52%)1 (4%)20 (39%)26 (51%)5 (10%)60 (50%)51 (42%)8 (7%)
Events
 Fatigue15 (56%)4 (15%)034 (67%)2 (4%)073 (61%)7 (6%)0
 Diarrhea16 (59%)2 (7%)023 (45%)5 (10%)060 (50%)11 (9%)0
 Rasha12 (44%)5 (19%)020 (39%)7 (14%)047 (39%)14 (12%)0
 Nausea11 (41%)1 (4%)022 (43%)1 (2%)048 (40%)2 (2%)0
 Decreased appetite13 (48%)0011 (22%)0042 (35%)00
 Mucosal inflammation3 (11%)0015 (29%)3 (6%)027 (23%)4 (3%)0
 Hyperglycemia01 (4%)1 (4%)5 (10%)9 (18%)09 (8%)18 (15%)2 (2%)
 Vomiting5 (19%)0010 (20%)1 (2%)024 (20%)1 (1%)0
 Pruritus2 (7%)0013 (25%)1 (2%)022 (18%)1 (1%)0
 Dry skin7 (26%)007 (14%)1 (2%)016 (13%)1 (1%)0
 Pneumonitis3 (11%)1 (4%)01 (2%)2 (4%)2 (4%)8 (7%)4 (3%)2 (2%)
 Liver dysfunctionb1 (4%)1 (4%)02 (4%)6 (12%)04 (3%)9 (8%)0
  • aRash includes maculopapular, pruritic, macular, erythematous, and generalized rashes.

  • bLiver dysfunction includes abnormal liver function tests, namely raised transaminases, gamma-glutamyltransferase alanine, and aspartate aminotransferases.