Table 3 - Patient Screening and Enrollment, Trials A and B

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Table 3 provides an example of how screening and enrollment data should be displayed.

Reference: FDA-2022-N-1961-0002_attachment_1 on page 14.

Description

Patient Screening and Enrollment, Trials A and B

Analysis Datasets

ADSL

When using data from the scda package, please use datasets with archive_name set to "rcd_2022_10_13".

Analysis Filtering

The populations should be defined as follows:

• Screened population: All patients screened for entry into the trial
• Enrolled population: All patients who signed a consent form for participation in the trial
• Randomized population: All patients randomized to a treatment arm; often referred to as the intention-to-treat population
• If screening failure data are available, provide reasons for screen failure, such as “patient noncompliance,” “consent withdrawn,” “inclusion/exclusion criteria not met,” “other.” Request breakdown of “inclusion/exclusion criteria not met” and “other,” because understanding reasons for screen failure can be informative to assess the generalizability of the trial.

Column Variable

ARM

Additional Notes

N/A

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