Table 1.

Component Definitions for Complicated Intra-abdominal Infection–Specific Desirability of Outcome Ranking Endpoint

Component Events	Definition
Absence of clinical response	Includes outcomes of clinical failure or indeterminate as assessed by the investigator at the TOCa visit. If the participant's clinical course was reviewed by the SRP, the SRP's clinical assessment prevails.
Infectious complications	Newly identified infections that were not initially diagnosed at the start of the trial, including those related and unrelated to the original cIAI.
Surgical/percutaneous procedures	Any additional abdominal interventions, to include surgical, percutaneous, or endoscopic procedures, that the participant has after their first operation for cIAI. Any postoperative wound-related surgical or percutaneous interventions that the participant has after their first operation for cIAI.
Serious adverse events	Includes SAEs as defined by the Code of Federal Regulations (21 C.F.R. § 312.32)b,c

Abbreviations: cIAI, complicated intra-abdominal infection; SAE, serious adverse event; SRP, surgical review panel; TOC, test of cure.

The time frame for the TOC visit varied slightly by trial, as did the point from which the TOC was measured. For example, some trials measured the TOC from randomization, while others measured from the first or last dose of therapy. The earliest TOC visit was conducted 14 days after randomization, while the latest TOC visit was conducted 50 days after randomization.

Any medical event that (1) results in death, (2) is life-threatening, (3) requires inpatient hospitalization or prolongation of existing hospitalization, (4) results in persistent or significant disability/incapacity, or (5) is a congenital anomaly/birth defect.

If an SAE was also in the infectious complication component, this counted as 2 events for the desirability of outcome ranking.