HLT Bullous conditions PT Stevens-Johnson syndrome PT Toxic epidermal necrolysis HLT Exfoliative conditions PT Dermatitis exfoliative PT Dermatitis exfoliative generalised PT Nikolsky's sign PT Skin exfoliation The frequency of a medical concept may be underestimated if the above points are not considered; this may impact interpretation of data (see Section 3.2). MedDRA SOCs group terms by body systems, aetiologies and specialised purposes. Data may be coded to terms in SOCs that had not been anticipated by the user. Keep in mind the potential impact of multiaxiality on frequencies of the medical condition of interest. Example Preferred Term Primary SOC Injury, poisoning Post procedural haemorrhage and procedural complications General disorders and administration site Chest pain conditions MedDRA Versioning MedDRA is updated twice yearly. Version contains both simple and complex “X.0” changes; version contains only simple changes. “X.1” Organisations should be aware of the types of MedDRA changes for their possible impact on data output. Types of MedDRA Changes Simple Changes Complex Changes Add a PT (new medical concept) Add or change multiaxial links Move an existing PT from one HLT to Add new grouping terms another Merge existing grouping terms Demote a PT to LLT level Restructure a SOC Add or remove a link to an existing PT Add an LLT Move an existing LLT from one PT to another Promote an LLT to PT level
HLT Bullous conditions PT Stevens-Johnson syndrome PT Toxic epidermal necrolysis HLT Exfoliative conditions PT Dermatitis exfoliative PT Dermatitis exfoliative generalised PT Nikolsky's sign PT Skin exfoliation The frequency of a medical concept may be underestimated if the above points are not considered; this may impact interpretation of data (see Section 3.2). MedDRA SOCs group terms by body systems, aetiologies and specialised purposes. Data may be coded to terms in SOCs that had not been anticipated by the user. Keep in mind the potential impact of multiaxiality on frequencies of the medical condition of interest. Example Preferred Term Primary SOC Post procedural haemorrhage Injury, poisoning and procedural complications Chest pain General disorders and administration site conditions MedDRA Versioning MedDRA is updated twice yearly. Version “X.0” contains both simple and complex changes; version “X.1” contains only simple changes. Organisations should be aware of the types of MedDRA changes for their possible impact on data output. Types of MedDRA Changes Simple Changes Complex Changes Add a PT (new medical concept) Move an existing PT from one HLT to another Demote a PT to LLT level Add or remove a link to an existing PT Add an LLT Move an existing LLT from one PT to another Promote an LLT to PT level Add or change multiaxial links Add new grouping terms Merge existing grouping terms Restructure a SOC
9610-1800_datretptc_r3_9_mar2015_0.docx