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Table 1 Definitions of Data Analysis Populationsa

From: Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives

Population

Definitionc

ITT

All randomized patients are analyzed, regardless of whether each patient completed the trial, or even took a dose of study medication.b

mITT

All patients randomized patients are analyzed, if they fit a predefined modification to the ITT population. A common modification is including all patients who were randomized and also received at least one treatment dose.

PP

Only the patients who completed treatment according to the planned protocol are analyzed.

  1. aITT intention-to-treat, mITT modified ITT, PP per protocol
  2. bITT may also be defined with the added caveat that there are no missing measurements; however, this standard was not applied in this investigation
  3. c[2]
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BMC Medical Research Methodology

ISSN: 1471-2288

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