Example as of MedDRA Version 19.0 Granularity MedDRA PTs are more specific (“granular”) than comparable terms in other terminologies. Figure 1 illustrates how data coded to a single concept from another terminology may be coded to several PTs in MedDRA. Related events that may have been represented by a single term in another terminology may be represented by more than one MedDRA PTs. The potential impact of this on signal detection should be kept in mind. Multiaxiality Multiaxiality means that a PT may exist in more than one SOC. This allows terms to be grouped in different, but medically appropriate, ways (e.g., by etiology or organ system). Each PT is assigned one primary SOC; all other SOC assignments for that PT are called Having a single primary SOC prevents double counting of events when “secondary”. outputting data from all SOCs. All possible secondary SOC assignments for any given PT may not be present in MedDRA. However, new or revised SOC assignments can be created as a result of the change request process. Primary SOC assignment trial Primary SOC assignment rules are described in the MedDRA Introductory Guide. These rules affect the way terms are placed in MedDRA and determine their data display by SOC. Because these rules allow for terms related to a particular medical condition to be in more than one SOC, users should be familiar with the general structure and content of all MedDRA SOCs to be sure that data are not overlooked. Example Type of Disorder Primary SOC Rule Example Comment Congenital All terms for PT Congenital The secondary SOC congenital disorders absence of bile assignment for these terms have as their primary has a primary SOC is their of “site SOC assignment assignment of SOC manifestation” SOC SOC Congenital, Congenital, familial familial and genetic and genetic disorders disorders and a secondary SOC assignment of SOC Hepatobiliary disorders Neoplastic All terms for PT has a and terms are Skin cancer Cyst polyp malignant and benign primary SOC an exception to this rule.
Example as of MedDRA Version 19.0 Granularity MedDRA PTs are more specific (“granular”) than comparable terms in other terminologies. Figure 1 illustrates how data coded to a single concept from another terminology may be coded to several PTs in MedDRA. Related events that may have been represented by a single term in another terminology may be represented by more than one MedDRA PTs. The potential impact of this on signal detection should be kept in mind. Multiaxiality Multiaxiality means that a PT may exist in more than one SOC. This allows terms to be grouped in different, but medically appropriate, ways (e.g., by etiology or organ system). Each PT is assigned one primary SOC; all other SOC assignments for that PT are called “secondary”. Having a single primary SOC prevents double counting of events when outputting data from all SOCs. All possible secondary SOC assignments for any given PT may not be present in MedDRA. However, new or revised SOC assignments can be created as a result of the change request process. Primary SOC assignment Primary SOC assignment rules are described in the MedDRA Introductory Guide. These rules affect the way terms are placed in MedDRA and determine their data display by SOC. Because these rules allow for terms related to a particular medical condition to be in more than one SOC, users should be familiar with the general structure and content of all MedDRA SOCs to be sure that data are not overlooked. Example Type of Disorder Primary SOC Rule Example Comment Congenital All terms for congenital disorders have as their primary SOC assignment SOC Congenital, familial and genetic disorders PT Congenital absence of bile has a primary SOC assignment of SOC Congenital, familial and genetic disorders and a secondary SOC assignment of SOC Hepatobiliary disorders The secondary SOC assignment for these terms is their “site of manifestation” SOC Neoplastic All terms for malignant and benign PT Skin cancer has a primary SOC Cyst and polyp terms are an exception to this rule. trial
000099_datretptc_r3_14_sep2017_rl_0.docx