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_Product | Brandname of the centrally authorized product | string | required : 1 |
| Active_Substance | Active substance in the medicinal product | string | - |
| Date_Of_Most_Recent_SPC | Date 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.html | string | - |
| Adverse_Drug_Reaction_Term | Adverse Drug Reaction term as it appears in the SPC | string | - |
| SOC_If_No_Matching_PT | System Organ Class | string | - |
| HLGT_If_No_Matching_PT | High Level Group Term | string | - |
| HLT_If_No_Matching_PT | High Level Term | string | - |
| LLT_If_No_Matching_PT | Low Level Term | string | - |
| MedDRA_PT_Text | MedDRA Preferred Term | string | - |
| MedDRA_PT_Code | Preferred Term Code | number | level : Nominal |
| MedDRA_SOC_Code | System Organ Class Code | number | level : Nominal |
| Age_Group | Age group, if ADR is mentioned to be related to age group | string | - |
| Gender | Gender if ADR is mentioned to be related to gender | string | - |
| Causality | Coding 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 ADR | string | - |
| Frequency | The 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_Warning | Does 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_Trial | Is 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_Surveillance | Post-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 | - |
| Comment | This 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 Product | Active Substance | Date Of Most Recent SPC | Remarks On Date Of Most Recent SPC | Adverse Drug Reaction Term | SOC If No Matching PT | HLGT If No Matching PT | HLT If No Matching PT | LLT If No Matching PT | MedDRA PT Text | MedDRA PT Code | MedDRA SOC Code | Age Group | Gender | Causality | Frequency | Is Class Warning | Is Clinical Trial | Is Post Marketing Surveillance | Comment |
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | ALLERGIC REACTIONS | allergic reaction | HYPERSENSITIVITY | 10020751 | 10021428 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Rare | True | False | False | |||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | ANGIOOEDEMA | ANGIOEDEMA | 10002424 | 10040785 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Unknown, not mentioned or no standard category | True | False | False | ||||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | BRONCHOSPASM | BRONCHOSPASM | 10006482 | 10038738 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Unknown, not mentioned or no standard category | True | False | False | ||||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | DYSGEUSIA | DYSGEUSIA | 10013911 | 10029205 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Very rare | False | False | False | ||||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | HYPOGLYCAEMIA | HYPOGLYCAEMIA | 10020993 | 10027433 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Very common | False | False | False | ||||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | HYPOTENSION | HYPOTENSION | 10021097 | 10047065 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Unknown, not mentioned or no standard category | True | False | False | ||||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | INJECTION SITE HIVES | injection site hives | INJECTION SITE URTICARIA | 10022107 | 10018065 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Common | False | False | False | |||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | INJECTION SITE INFLAMMATION | INJECTION SITE INFLAMMATION | 10022078 | 10018065 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Common | False | False | False | ||||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | INJECTION SITE ITCHING | injection site itching | INJECTION SITE PRURITUS | 10022093 | 10018065 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Common | False | False | False | |||||
| Abasaglar | INSULIN GLARGINE | 2014-09-09 | INJECTION SITE PAIN | INJECTION SITE PAIN | 10022086 | 10018065 | Age category not specified or unclear | Not specified, unclear or both genders | Established ADR (default value for all ADRs listed in the Table) | Common | False | False | False |
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