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Important Medical Event (IME) list

Important Medical Event (IME) list. Updated to MedDRA version 13.0. What has been done since version 12.0?. Drafting of inclusion and exclusion criteria Finalisation of the IME list now updated to MedDRA version 13.0: 10101 PTs (about 30% ES, 70% CS)

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Important Medical Event (IME) list

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  1. Important Medical Event (IME) list Updated to MedDRA version 13.0

  2. What has been done since version 12.0? • Drafting of inclusion and exclusion criteria • Finalisation of the IME list now updated to MedDRA version 13.0: • 10101 PTs (about 30% ES, 70% CS) • To obtain a copy of these documents, please send an email to • MedDRAIMElist@ema.europa.eu Important Medical Event (IME) list

  3. Drafting of inclusion/exclusion criteria • A set of overall inclusion/exclusion criteria + SOC specific criteria have been developed and updated to v. 13.0 • These now apply also to: • SOCs excluded in full in v. 12.0: • SOC Social circumstances • SOC Surgical and medical procedures • SOCs included in full in v. 12.0: • SOC Congenital familial and genetic disorders • SOC Neoplasm benign, malignant and unspecified (incl. cysts and polyps) • SOC Infections and Infestation Important Medical Event (IME) list

  4. Finalisation of IME list v. 13.0 (I) • Methodology applied: • Review all the PTs in MedDRA v. 12.1 against the newly developed incl./excl. criteria and ADD/DELETE terms as applicable • The newly v. 12.1 added terms based on this review are in red, blue, and green font • Identify new PTs in MedDRA v. 13.0 that fit the incl./excl. criteria and ADD them as applicable. • These are designated with an “x” in column labeled “added v.13.0” Important Medical Event (IME) list

  5. Finalisation of IME list v. 13.0 (II) • See if for any of the PTs which had been demoted to LLT, the current “parent” PT was already included in the IME list or should otherwise be included. Also changes in primary SOC for the terms were noted • Complete the designation of ES/CS also for newly added terms from SOCs Social circumstances and Surgical and medical procedures Important Medical Event (IME) list

  6. Input needed from you • Please provide your comments (and specify in the subject of your email “comments on IME list, version 13.0”) toMedDRAIMElist@ema.europa.euon: • The final IME list, MedDRA v. 13.0: please provide your comments in the column of the spreadsheet labelled “Comments (in case of disagreement)” • The inclusion and exclusion criteria: please provide your comments in the word document using the track changes activated Important Medical Event (IME) list

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