Example Impact of Version Changes Demoted PT – PT Metastatic pain was included in a query developed using terms in MedDRA Version 18.1. If the query had been re-run on data using MedDRA Version 19.0, these events would not have been found at the PT level because PT Metastatic pain had been demoted to an LLT and linked to PT Cancer pain. See Figure 3. Example as of MedDRA Version 18.1 and 19.0 Example Impact of Version Changes Change of Primary SOC Assignment – PT Intra-abdominal haematoma had a primary link to SOC Vascular disorders and a secondary link to SOC Gastrointestinal disorders in MedDRA Version 18.0. In Version 18.1, the primary SOC assignment was changed to SOC Gastrointestinal disorders and the secondary assignment to SOC Vascular disorders. In a primary SOC output of data, PT Intra-abdominal haematoma will seem to have from “disappeared” SOC Vascular disorders. Example as of MedDRA Version 18.0 and 18.1 Terms used to construct queries should be in the same MedDRA version as the data being queried. An legacy data may be coded in more than one version of organisation’s MedDRA. New terms may have been included in a new query built in a newer MedDRA version; depending upon the versioning method, these new terms might not organisation’s be present in the older data. This could lead to search results that are incomplete. A search built with terms of an earlier MedDRA version (e.g., used previously on a now closed study) might not identify all relevant data in an integrated safety summary (ISS) containing data coded in a later version of MedDRA. Queries stored in an organisation’s system should be updated to the appropriate version of MedDRA before using them on new data. Advice on how an organisation should handle new MedDRA versions is not within the scope of this document (see MedDRA Term Selection: Points to Consider, Appendix 4.1). Some databases may contain data of multiple studies coded in different versions of MedDRA. This may impact aggregation of those data (e.g., in an ISS). Refer also to the MedDRA website for the MedDRA Best Practices for more information on versioning options for clinical trial and post-marketing data (see Appendix, Section 6.1).
Example Impact of Version Changes – Demoted PT PT Metastatic pain was included in a query developed using terms in MedDRA Version 18.1. If the query had been re-run on data using MedDRA Version 19.0, these events would not have been found at the PT level because PT Metastatic pain had been demoted to an LLT and linked to PT Cancer pain. See Figure 3. Example as of MedDRA Version 18.1 and 19.0 Example Impact of Version Changes – Change of Primary SOC Assignment PT Intra-abdominal haematoma had a primary link to SOC Vascular disorders and a secondary link to SOC Gastrointestinal disorders in MedDRA Version 18.0. In Version 18.1, the primary SOC assignment was changed to SOC Gastrointestinal disorders and the secondary assignment to SOC Vascular disorders. In a primary SOC output of data, PT Intra-abdominal haematoma will seem to have “disappeared” from SOC Vascular disorders. Example as of MedDRA Version 18.0 and 18.1 Terms used to construct queries should be in the same MedDRA version as the data being queried. An organisation’s legacy data may be coded in more than one version of MedDRA. New terms may have been included in a new query built in a newer MedDRA version; depending upon the organisation’s versioning method, these new terms might not be present in the older data. This could lead to search results that are incomplete. A search built with terms of an earlier MedDRA version (e.g., used previously on a now closed study) might not identify all relevant data in an integrated safety summary (ISS) containing data coded in a later version of MedDRA. Queries stored in an organisation’s system should be updated to the appropriate version of MedDRA before using them on new data. Advice on how an organisation should handle new MedDRA versions is not within the scope of this document (see MedDRA Term Selection: Points to Consider, Appendix 4.1). Some databases may contain data of multiple studies coded in different versions of MedDRA. This may impact aggregation of those data (e.g., in an ISS). Refer also to the MedDRA website for the MedDRA Best Practices for more information on versioning options for clinical trial and post-marketing data (see Appendix, Section 6.1).