Table 4.

Adverse Events Reported in Clinical Trials

	APEKS-NP, %		APEKS-cUTI, %		CREDIBLE-CR, %
Adverse Event	Cefiderocol (n = 148)	Meropenem (n = 150)	Cefiderocol (n = 300)	Imipenem-cilastam (n = 148)	Cefiderocol (n = 101)	Best Available Therapy (n = 49)
All TEAEs	88	86	41	51	91	96
Mild	22	25	NR	NR	23	18
Moderate	28	31	NR	NR	26	33
Severe	38	30	NR	NR	43	45
TEAEs	Reported >5% in either group		Reported >2% in either group		Reported >5% in either group
Diarrhea	9	9	4	6	19	12
Constipation	5	4	3	4	8	6
Nausea	NR	NR	2	4	7	4
Vomiting	NR	NR	2	1	13	14
Headache	NR	NR	2	5	NR	NR
Infusion site pain	NR	NR	3	3	NR	NR
Rash	1	0	NR	NR	3	8
Hypokalemia	11	15	2	3	9	14
Elevated LFTs	2.7	6.7			8	2
TEAE leading to drug discontinuation	8	9	2	2	3	4
Drug-related TEAEs	9	11	9	11	15	22
Serious adverse events	36	30	5	8	50	47
Clostridium difficile–associated disease	3	3	<1	3	1	0

Numbers of patients included in the safety analysis of each study.

Abbreviations: LFT, Liver function test; NR, not reported; TEAE, treatment emergent adverse events.