Table 2.

Selected adverse events in patients with chronic lymphocytic leukemia treated with idelalisib alone or in combination with rituximab in clinical trials.³⁸,³⁹,⁵⁹

	% any grade	% grade ≥3
AE of special interest:
Pneumonitis	3–4	3–4
Diarrhea/colitis	19–64	4–42
ALT or AST elevation	35	5
AP elevation	33	0
GGT elevation	20	2
Bilirubin elevation	26	0
Cytopenias:
Neutropenia	55–57	34–43
Anemia	25–37	5–11
Thrombocytopenia	17–30	10–17
Infections (selected):
Pneumonia	9–28	9–20
URI	22
Cellulitis	1–6	1–6
Bacteremia	6	6
Sepsis	7	7
Sinusitis	11	2
UTI	16	6
Fever (non neutropenic)	28–42	3–4
Neutropenic fever	5–11	5–11
Other AE (selected):
Hypertriglyceridemia	56	4
Hyperglycemia	46	6
Hypocalcemia	44	4
Hypernatremia	30	4
Fatigue	24–31	2–3
Hyoglycemia	26	4
Nausea/vomiting	24–38	0–3
Back pain	16–22	2
Chills	17–36	2
Cough	15–33	0–4
Rash	10–58	2–13
Headache	13–23	0
Constipation	12–17	0
Arthralgia	11–17	0–2
Edema	11	0

Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; AP, alkaline phosphatase; GGT, gamma glutamyltransferase; URI, upper respiratory infection; UTI, urinary tract infection.