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

If participants were enrolled before trial termination but no data were collected for one or more Outcome Measures, specify zero ("0") in the relevant Number of Participants Analyzed data element and leave the data fields blank for each Arm/Group. In this case, use the Analysis Population Description data element to explain that the trial was terminated before the outcome measure data were collected and, if appropriate, provide additional details in the Limitations and Caveats module. All other required results information collected for the enrolled participants will need to be submitted in each results module even though no data were collected for one or more Outcome Measures.