Others titles

  • medDRA System Organ Class Database
  • PROTECT Adverse Drug Reactions Database
  • Adverse Drug Effects Database

Keywords

  • Adverse Drug Reactions
  • Meddra Preferred Term List
  • Preferred Terms
  • System Organ Class List
  • Meddra Terms Listing
  • Adverse Event
  • Adverse Effects

Adverse Reaction with Preferred Term and System Organ Class Codes

The database includes adverse drug reaction that is associated with the product and substance with MedDRA Preferred Term (PT), PT codes, System Organ Class (SOC) codes etc. This structured database can be used to know whether or not adverse reactions are recorded in the European Summary of Product Characteristics (SPC).

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Description

The Protect Adverse Drug and Product Reaction Database lists adverse drug reactions in 4.8 of the Summary of Product Characteristics (SPPC) of the EU authorized medicinal products based on centralized procedure. The database follows MedDRA terminology. MedDRA Preferred Terms (PT) are used to facilitate the accuracy of ADR descriptions.

MedDRA Preferred Terms (PT) are used to map terms of the SPC. When they are used in the SPC to add precision in the description of the ADR, Low Level Terms (LLTs) are also coded. PTs and LLTs are linked to a primary System Organ Class (SOC). The dataset also includes information on gender, causality, frequency, class warning and source of information for ADRs for which additional information is provided in the SPC.

About this Dataset

Data Info

Date Created

2015-06-30

Last Modified

2017-07-04

Version

2016-06-30

Update Frequency

Annual

Temporal Coverage

N/A

Spatial Coverage

N/A

Source

John Snow Labs; European Medicines Agency (EMA) and PROTECT Partners;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Adverse Drug Reactions, Meddra Preferred Term List, Preferred Terms, System Organ Class List, Meddra Terms Listing, Adverse Event, Adverse Effects

Other Titles

medDRA System Organ Class Database, PROTECT Adverse Drug Reactions Database, Adverse Drug Effects Database

Data Fields

Name Description Type Constraints
Medicinal_ProductBrandname of the centrally authorized productstringrequired : 1
Active_SubstanceActive substance in the medicinal productstring-
Date_Of_Most_Recent_SPCDate of the most recent Summary of Product Characteristic. Whichever date is most recent: date of first authorization or date of the latest version of the SPC found on the European Commission website http://ec.europa.eu/health/documents/communityregister/html/brand_full.html.date-
Remarks_On_Date_Of_Most_Recent_SPC"Opinion" is mentioned as a remark against the date regarding if the date of the most recent Summary of Product Characteristic is opinionated. Date of most recent SPC can be found on the European Commission website http://ec.europa.eu/health/documents/communityregister/html/brand_full.htmlstring-
Adverse_Drug_Reaction_TermAdverse Drug Reaction term as it appears in the SPCstring-
SOC_If_No_Matching_PTSystem Organ Classstring-
HLGT_If_No_Matching_PTHigh Level Group Termstring-
HLT_If_No_Matching_PTHigh Level Termstring-
LLT_If_No_Matching_PTLow Level Termstring-
MedDRA_PT_TextMedDRA Preferred Termstring-
MedDRA_PT_CodePreferred Term Codenumberlevel : Nominal
MedDRA_SOC_CodeSystem Organ Class Codenumberlevel : Nominal
Age_GroupAge group, if ADR is mentioned to be related to age groupstring-
GenderGender if ADR is mentioned to be related to genderstring-
CausalityCoding of any additional wording existing in the SPC and providing additional information on the strength of causal association. If a product is made of more than one substance, and an ADR has occurred with one substance only, the ADR has been listed with a causality of 0 (established ADR) and a comment has been added in the Comment field to indicate which substance has caused the ADRstring-
FrequencyThe frequency category mentioned in the Table of ADRs. The comment “CF” (conflicting frequencies) has been added in the Comment field when an ADR has been observed with two conflicting frequencies for the same product. This could happen in the following cases: - when several clinical trials with different results (and sometimes different indications) are reported in the SPC; - when ADRs are listed for each individual component of a product. If a frequency is described with a percentage rather than with a standard wording (i.e. unknown, very rare, rare, uncommon, common or very common), the category is “0” as figures have not been interpreted.string-
Is_Class_WarningDoes the SPC (section 4.8) indicate that the adverse reaction is observed in the same class of drug or is pharmacological class effect (or is there a similar statement)?boolean-
Is_Clinical_TrialIs the adverse reaction listed in a table presenting results of clinical trials, or is it mentioned in the context of clinical trials?boolean-
Is_Post_Marketing_SurveillancePost-marketing surveillance. Is the adverse reaction listed in a table presenting data from post-marketing surveillance, or is it mentioned in the context of post-marketing surveillance? If the SPC states that the ADRs have been observed from spontaneous reporting and in clinical trials without specifying which ADRs have been observed in which, then “false” has been entered in both fields “Clinical Trial” and “Post-marketing surveillance”.boolean-
CommentThis field has been used to include any additional useful information like ADRs occurring in specific indications or with concomitant drugs, to explain the causality assessment, or to indicate with which individual drug component an ADR has been observed.string-

Data Preview

Medicinal ProductActive SubstanceDate Of Most Recent SPCRemarks On Date Of Most Recent SPCAdverse Drug Reaction TermSOC If No Matching PTHLGT If No Matching PTHLT If No Matching PTLLT If No Matching PTMedDRA PT TextMedDRA PT CodeMedDRA SOC CodeAge GroupGenderCausalityFrequencyIs Class WarningIs Clinical TrialIs Post Marketing SurveillanceComment
AbasaglarINSULIN GLARGINE2014-09-09ALLERGIC REACTIONSallergic reactionHYPERSENSITIVITY1002075110021428Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)RareTrueFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09ANGIOOEDEMAANGIOEDEMA1000242410040785Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)Unknown, not mentioned or no standard categoryTrueFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09BRONCHOSPASMBRONCHOSPASM1000648210038738Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)Unknown, not mentioned or no standard categoryTrueFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09DYSGEUSIADYSGEUSIA1001391110029205Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)Very rareFalseFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09HYPOGLYCAEMIAHYPOGLYCAEMIA1002099310027433Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)Very commonFalseFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09HYPOTENSIONHYPOTENSION1002109710047065Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)Unknown, not mentioned or no standard categoryTrueFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09INJECTION SITE HIVESinjection site hivesINJECTION SITE URTICARIA1002210710018065Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)CommonFalseFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09INJECTION SITE INFLAMMATIONINJECTION SITE INFLAMMATION1002207810018065Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)CommonFalseFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09INJECTION SITE ITCHINGinjection site itchingINJECTION SITE PRURITUS1002209310018065Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)CommonFalseFalseFalse
AbasaglarINSULIN GLARGINE2014-09-09INJECTION SITE PAININJECTION SITE PAIN1002208610018065Age category not specified or unclearNot specified, unclear or both gendersEstablished ADR (default value for all ADRs listed in the Table)CommonFalseFalseFalse