MEDRACODE dataset

Is a maping between adverse event prefered term, low level code and system/organ class term. Contains variables: aelltcd-AELLTCD, aept-"Preferred Term", aesoc-"System/Organ Class", llt.code-"MEDDRA Code"

AE dataset

CRF adverse events dataset. Contains aemedllt-"MEDDRA Code", aemedsyn-"MEDDRA Synonym", aetx -"Adverse Event", aevtx-"Adverse Event Verbatim Text", and more...

OCEANS SAE dataset

OCEANS serious adverse events dataset. Contains llt.code-"low level term code", soc.name-"system/organ name", pt.name-"prefered name(term)", pt.code-?, llt.name-"low level term", aelltcd-?, and more...

SAE dataset

Is a result of merge of MEDRACODE, AE(only serious adverse events) and OCEANS SAE. First AE and OCEANS SAE data are merged by "subject","date.of.onset" and "llt.code" (variable "aemedllt" in AE is renamed to "llt.code"). Then MEDRACODE is merged by "llt.code". If "aept", "aesoc" are not available "pt.name", "soc.name" are used correspondently. If "llt.name" is not available "aevtx" is used. Other substitutions are made (see file import.s for details).

Which variables of SAE should be used for the report

Variables "aesoc", "aept" should be used for frequency tables. For listings verbatim text ("aevtx") may be included (Matt's recomendation)