How do I submit results information if the trial is terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures?

If no participants were ever enrolled in the trial, set the Overall Recruitment Status to Withdrawn, and no further results information will need to be submitted.

For a trial that was terminated after participants were enrolled, provide any available data. If no data are available for any of the Outcome Measures, specify zero ("0") for the Number of Participants Analyzed in each Arm/Group, and leave the data fields blank. In this case, provide an explanation in the Analysis Population Description for why zero participants were analyzed and, if appropriate, provide information in the Limitations and Caveats module. Even if data are not entered for Outcome Measures, submit the available data for the enrolled participants in the Participant Flow, Baseline Characteristics, and Adverse Events modules.