Skip to main content

Table 2 Populations for analysis

From: Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial

Population (analysis set) Description
Intent-to-treat (ITT) population The ITT population will include all randomized participants. The ITT participants will be analyzed according to randomized treatment, irrespective of the actual treatment received. All efficacy analyses will be performed using the ITT population.
Modified intent-to-treat (mITT) population The mITT population will include all randomized participants. The ITT participants will be analyzed according to randomized treatment and who have been given at least one dose of treatment. The mITT population will be used for supportive analyses of the efficacy measurements.
Per protocol (PP) population The PP population will include all participants in the ITT population with no major protocol deviations that may significantly impact data integrity or patient safety. The PP population will be used for supportive analyses of the efficacy measurements.
Safety population (SP) The SP will include all randomized participants who have been given at least one dose of treatment (IVIG or placebo). The SP will be analyzed according to the actual treatment received. This set will be used for the safety analyses.