https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840341#M332284 Does ADAE dataset have screen failure subjects ..?? Mon, 24 Oct 2022 18:18:15 GMT MK_96 2022-10-24T18:18:15Z https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840341#M332284 Does ADAE dataset have screen failure subjects ..?? Mon, 24 Oct 2022 18:18:15 GMT https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840341#M332284 MK_96 2022-10-24T18:18:15Z https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840488#M332326 I think it is not .<BR />AE means adverse event which is from the subject who have already taken drugs.<BR />If subject was screen failure,He can't take drugs. Tue, 25 Oct 2022 11:44:23 GMT https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840488#M332326 Ksharp 2022-10-25T11:44:23Z https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840489#M332327 And Better post it at CDISC forum:<BR /><A href="https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/bd-p/sas_health_pharma" target="_blank">https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/bd-p/sas_health_pharma</A><BR /><A href="https://communities.sas.com/t5/SAS-Life-Science-Analytics/cmp-p/grouphub%3Alife_sciences" target="_blank">https://communities.sas.com/t5/SAS-Life-Science-Analytics/cmp-p/grouphub%3Alife_sciences</A> Tue, 25 Oct 2022 11:45:31 GMT https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840489#M332327 Ksharp 2022-10-25T11:45:31Z https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840565#M332342 It depends on the definition of your protocol. I have seen studies where the AEs were collected two months before inclusion, in that case , yes it includes the screen failures. The AE that happen during the treatment period are called : treatment emergent AEs ( TEAEs).<BR />Check your protocol, and if nothing is there, ask the clinician and the stat of your study. Tue, 25 Oct 2022 14:25:28 GMT https://communities.sas.com/t5/SAS-Programming/ADAE/m-p/840565#M332342 Noudjoum 2022-10-25T14:25:28Z