Ceftolozane/tazobactam versus meropenem in patients with ventilated hospital-acquired bacterial pneumonia: subset analysis of the ASPECT-NP randomized, controlled phase 3 trial

Table 4 Adverse event summary in ASPECT-NP participants with ventilated hospital-acquired bacterial pneumonia by treatment arm

Adverse event category, n (%)	C/T (N = 99)	Meropenem (N = 105)	Total (N = 204)
Number of patients with ≥ 1 TEAE	88 (88.9)	92 (87.6)	180 (88.2)
Number of patients with ≥ 1 TEAE by maximum severity*
Mild	15 (15.2)	14 (13.3)	29 (14.2)
Moderate	30 (30.3)	28 (26.7)	58 (28.4)
Severe	43 (43.4)	50 (47.6)	93 (45.6)
Number of patients with ≥ 1 DRAE^‡	13 (13.1)	11 (10.5)	24 (11.8)
Number of patients with ≥ 1 serious TEAE	49 (49.5)	48 (45.7)	97 (47.5)
Number of patients with ≥ 1 serious DRAE^‡	3 (3.0)	1 (1.0)	4 (2.0)
Number of patients with ≥ 1 TEAE leading to study drug discontinuation	8 (8.1)	18 (17.1)	26 (12.7)
Number of patients with ≥ 1 DRAE leading to study drug discontinuation^‡	2 (2.0)	1 (1.0)	3 (1.5)
Number of patients with ≥ 1 TEAE resulting in death	31 (31.3)	41 (39.0)	72 (35.3)
Number of patients with ≥ 1 DRAE resulting in death^‡	0	0	0

Adverse events were coded using MedDRA version 17.0. For each category, patients counted only once, even if they experienced multiple events in the category
AE, adverse event. C/T, ceftolozane/tazobactam. DRAE, drug-related adverse event. n, number of patients in specific category. N, number of patients in safety population. TEAE, treatment-emergent adverse event (defined as any AE starting on/after the first study drug administration)
*If patients have multiple events, they are counted only once with the maximum (highest) severity rating. The orders of severity from worst case to best case are severe, moderate, and mild
^‡If a patient had multiple events and ≥ 1 was deemed related to study drug, then that patient was included into the count

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