Table 1.

Adverse events related to acalisib in ≥5% of all patients, and all acalisib-related infections

Adverse events, n (%)	50 mg BID (N = 3)		100 mg BID (N = 3)		200 mg BID (N = 3)		400 mg BID (N = 29)		Total (N = 38)
	All	Grade ≥3	All	Grade ≥3	All	Grade ≥3	All	Grade ≥3	All	Grade ≥3
AEs related to acalisib	3 (100)	1 (33.3)	2 (66.7)	1 (33.3)	2 (66.7)	1 (33.3)	23 (79.3)	18 (62.1)	30 (78.9)	21 (55.3)
Diarrhea	2 (66.7)	1 (33.3)	0	0	1 (33.3)	0	6 (20.7)	3 (10.3)	9 (23.7)	4 (10.5)
Rash	0	0	0	0	0	0	8 (27.6)	4 (13.8)	8 (21.1)	4 (10.5)
Weight decreased	1 (33.3)	0	0	0	0	0	5 (17.2)	1 (3.4)	6 (15.8)	1 (2.6)
Alanine aminotransferase increased	0	0	1 (33.3)	0	0	0	4 (13.8)	1 (3.4)	5 (13.2)	1 (2.6)
Aspartate aminotransferase increased	0	0	1 (33.3)	0	0	0	4 (13.8)	1 (3.4)	5 (13.2)	1 (2.6)
Dysgeusia	0	0	0	0	0	0	5 (17.2)	0	5 (13.2)	0
Cough	0	0	0	0	0	0	4 (13.8)	0	4 (10.5)	0
Pyrexia	0	0	0	0	0	0	3 (10.3)	0	3 (7.9)	0
Nausea	0	0	0	0	0	0	3 (10.3)	0	3 (7.9)	0
Neutrophil count decreased	0	0	0	0	0	0	3 (10.3)	3 (10.3)	3 (7.9)	3 (7.9)
Drug eruption	0	0	0	0	0	0	2 (6.9)	0	2 (5.3)	0
Blood alkaline phosphatase increased	0	0	0	0	0	0	2 (6.9)	0	2 (5.3)	0
Anemia	0	0	0	0	0	0	2 (6.9)	1 (3.4)	2 (5.3)	1 (2.6)
Hypokalemia	0	0	0	0	0	0	2 (6.9)	1 (3.4)	2 (5.3)	1 (2.6)
All acalisib-related infections and infestations, by preferred term
Pneumonia	1 (33.3)	0	0	0	0	0	1 (3.4)	1 (3.4)	2 (5.3)	1 (2.6)
Lung infection	0	0	0	0	0	0	1 (3.4)	0	1 (2.6)	0
Bronchiolitis	0	0	0	0	0	0	1 (3.4)	1 (3.4)	1 (2.6)	1 (2.6)
Pneumonia viral	0	0	0	0	0	0	1 (3.4)	1 (3.4)	1 (2.6)	1 (2.6)
Mycobacterial infection	0	0	0	0	0	0	1 (3.4)	0	1 (2.6)	0
Varicella zoster virus infection	0	0	0	0	0	0	1 (3.4)	0	1 (2.6)	0
Parainfluenza virus infection	0	0	0	0	0	0	1 (3.4)	0	1 (2.6)	0
Pneumocystis jirovecii pneumonia	0	0	0	0	0	0	1 (3.4)	1 (3.4)	1 (2.6)	1 (2.6)
Upper respiratory tract infection	0	0	0	0	0	0	1 (3.4)	0	1 (2.6)	0
Urinary tract infection	0	0	0	0	1 (33.3)	1 (33.3)	0	0	1 (2.6)	1 (2.6)

Patients who experienced multiple events within the same preferred term are counted once

BID twice daily