Table 3.

Adverse events as assessed by the investigators²¹

Adverse events, n (%)	L-AMB (N = 237)	Placebo (N = 118)	P valuea
Any treatment-emergentb AE	237 (100)	115 (97.5)	0.036
pyrexia	67 (28.3)	40 (33.9)	0.33
hypotension	18 (7.6)	15 (12.7)	0.12
Treatment-emergentb renal AEs
hypokalaemia, any grade	83 (35.0)	21 (17.8)	<0.001
<LLN (3.0 mmol/L)	45 (19.0)	12 (10.2)	0.03
<LLN (3.0 mmol/L); symptomatic, intervention indicated	25 (10.5)	6 (5.1)	0.11
<3.0–2.5 mmol/L	10 (4.2)	2 (1.7)	0.35
<2.5 mmol/L	3 (1.3)	1 (0.8)	1.00
creatinine increase, any grade	22 (9.3)	0	<0.001
>1 to 1.5× baseline; >ULN to 1.5 × ULN	7 (3.0)	0	0.10
>1.5 to 3.0× baseline; >1.5 to 3.0 × ULN	15 (6.3)	0	0.003
>3.0× baseline; >3.0 to 6.0 × ULN	0	0	1.00
Other AE categories
serious adverse events (SAEs)	79 (33.3)	38 (32.2)	0.90
SAE related to study drug, any grade	20 (8.4)	2 (1.7)	0.02
AE leading to study drug interruption	48 (20.3)	9 (7.6)	0.002
AE leading to study drug discontinuation	63 (26.6)	26 (22.0)	0.37
any grade 3 AE	102 (43.0)	43 (36.4)	0.25
any grade 4 AE	69 (29.1)	40 (33.9)	0.39
AE related to death	17 (7.2)	8 (6.8)	1.00
AE related to ALL or ALL treatments	226 (95.4)	110 (93.2)	0.45
AE related to IFD	17 (7.2)	10 (8.5)	0.67

LLN, lower limit of normal; ULN, upper limit of normal.

^aFisher’s exact test.

^bTreatment emergent is defined as started on or after first dose and up to 30 days after last dose of study drug.