Page properties |
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Status | In progress |
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Version | 1.5 |
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Previous version | 1.0 |
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Descriptions:
Term | description type | Language/acceptability | LangaugeLanguage/acceptability | Case significance |
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Adverse [finding site] reaction to [agent] (disorder) | FSN | us:P | gb:P | ci |
Adverse [finding site] reaction to [agent] | SYN | us:P | gb:P | ci |
Concept model:
Attribute Cardinality | Attribute | Value | role group number | Role group cardinality |
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1..1 |
Scg expression |
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116680003|Is a (attribute)| |
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Scg expression |
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281647001 |Adverse reaction (disorder)| |
| 0 | | N/A |
1..1 |
Scg expression |
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246075003|Causative agent (attribute)| |
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Scg expression |
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[agent] << 105590001|Substance (substance)| OR << 373873005|Pharmaceutical / biologic product (product)| |
| OR << 260787004|Physical object (physical object)| OR << 78621006|Physical force (physical force)|1 | 1..1 |
0..1 |
Scg expression |
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363698007 |Finding site (attribute)| |
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Scg expression |
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[finding site] <123037004 |Body structure (body structure)| |
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Definition status:
Scg expression |
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900000000000073002|Defined (core metadata concept)| |
Template Language
281647001 |Adverse reaction (disorder)|: [[~1..1]] { [[~0..1]] 363698007 |Finding site (attribute)| = [[+id(< 123037004 |Body structure (body structure)|) @site]], [[~1..1]] 246075003 |Causative agent (attribute)| = [[+id( << << 105590001 |Substance (substance)| OR << OR << 373873005 |Pharmaceutical / biologic product (product)| OR << 260787004 |Physical object (physical object)| OR << 78621006 |Physical force (physical force)|) @agent]] }
Applies to:
Scg expression |
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<< 282100009 |Adverse reaction caused by substance (disorder)| MINUS <<418634005 |Allergic reaction caused by substance (disorder)| |
Editorial guidelines for selection of Causative agent attribute value:
The following editorial guidelines apply to concepts in the International Release; editorial guidelines for concepts in national extensions may vary.
Hierarchy | Concept Exception | Examples and Notes (Note: Examples are existing concepts and may not reflect the terming patterns described in the template.) |
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Substance base |
Base | yes | yes | Adverse reaction concepts representing a substance base should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|. |
none292350008 Alprazolam - Fluphenazine adverse reaction (disorder)|
Expected classification: - Classification results are expected to be consistent with the modeling of the concept selected as the Causative agent in the Substance hierarchy.
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Substance |
ModificationTBD | Example:
292392003 |Fluphenazine adverse reaction (disorder)|
, unless documented as exception | Adverse reaction concepts representing a substance modification should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|. Concepts representing substance modifications are exceptions and may be included if the adverse reaction profile is significantly different from the substance base. Exception examples: - Chemical element with multiple modifications (e.g. 422232005 |Calcium lactate gluconate (substance)|)
- Liposome or lipid complex substances (e.g. 412088006 |Amphotericin B liposome (substance)|, 426490000 |Vincristine liposome (substance)|)
- Pegylated substance (e.g. 385544005 |Pegfilgrastim (substance)|, 770965008 |Pegvaliase (substance)|)
- Salt forms (e.g. 412432007 |Metoprolol succinate (substance)|, 72770009 |Metoprolol tartrate (substance)|)
Example: - 292389002 |Fluphenazine decanoate adverse reaction (disorder)|
- 292390006 |Fluphenazine enanthate adverse reaction (disorder)|
Expected classification: - Classification results are expected to
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be consistent with the modeling in the Substance hierarchy based on the Is modification attribute and with other existing concepts in the subhierarchy. Concepts modeled using a modification should have the concept modeled using the base as an inferred parent - reflect that the concept modeled with the modified substance is a descendant of the concept modeled with the base substance (if such a concept exists
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.- (e.g. 292389002 |Fluphenazine decanoate adverse reaction (disorder)| has inferred parent 292392003 |Fluphenazine adverse reaction (disorder)|
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will |
Multiple substance | yes | Adverse reaction concepts representing multiple substances should be modeled |
with = 372730004 |Fluphenazine that is a descendant of 105590001 |Substance (substance)| |
and will have the following inferred descendants:; preferentially modeling with the base rather than a modification unless the adverse reaction profile is significantly different from the substance base. Example: - 292984002 |Ampicillin and cloxacillin
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292389002 |Fluphenazine decanoate - adverse reaction (disorder)|
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with Causative agent = 396063006 |Fluphenazine decanoate (substance)|- 292987009 |Piperacillin and tazobactam
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292390006 |Fluphenazine enanthate - adverse reaction (disorder)|
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with Causative agent = 111125005 |Fluphenazine enanthate (substance)|
Substance | Disposition grouper | yes | none | - 292989007 |Ticarcillin and clavulanic acid
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Example:
292736001 |Opioid antagonist - adverse reaction (disorder)|
Expected classification |
results(Agreed 21-Jan-2020): - Classification results are expected to be consistent with the modeling
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in the Substance hierarchy for concepts modeled with an attribute value from the Substance hierarchy.Product | Disposition grouper | no | none | No use case has been identified for use of this concept type for modeling in this subhierarchy. Disposition groupers in the Product hierarchy should only exist as SD concepts with a corresponding concept in the Substance hierarchy; the corresponding concept in the Substance hierarchy should be used for modeling in this subhierarchy. |
Substance | Role grouper | no | none | Role groupers in the Substance hierarchy will be inactivated in a future release and should not be used for modeling in this subhierarchy. Insert examples of role grouper. |
Product | Role grouper | yes | none | Example: Expected classification results: TBD if there are any restrictions on which product roles can be used in modeling in this subhierarchy |
- of the concept selected as the Causative agent in the Substance hierarchy.
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Disposition grouper | yes | Adverse reaction concepts representing a disposition grouper should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|. Example: - 293432006 |3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitor adverse reaction (disorder)|
- 870376001 |Adverse reaction to dopamine receptor agonist
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Substance | Structure grouper | yes | none | Example:
218638005 |Adverse reaction caused by hydantoin derivative Expected classification results: - Classification results are expected to
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be consistent with the modeling in the Substance hierarchy and with other existing concepts in the subhierarchy. Product | Structure grouper | no | none | No use case has been identified for use of this concept type for modeling in this subhierarchy. Structure groupers in the Product hierarchy should only exist as SD concepts with a corresponding concept in the Substance hierarchy; the corresponding concept in the Substance hierarchy should be used for modeling in this subhierarchy. |
Product or Substance | Body system grouper | no | none | Body system groupers in both the Substance and Product hierarchies will be inactivated in a future release and should no longer be used for modeling in this hierarchy. NEEDS INTERNAL AGREEMENT - agreed to inactivate these concepts.
Example:
293416008 |Drug groups primarily affecting cardiovascular system - reflect that the adverse reaction concepts are descendants of the appropriate disposition grouper based on the modeling of the 726542003 |Has disposition (attribute)| attribute in the substance hierarchy (e.g. 292113001 |Lansoprazole adverse reaction (disorder)|
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292670005 |Drug groups primarily affecting musculoskeletal system - has inferred parent 292111004 |Proton pump inhibitor adverse reaction (disorder)|).
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Role grouper |
Product | Medicinal product-containing | yes | yes | Adverse reaction concepts representing a role grouper should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|. Note that role groupers will be transitioned to the 763158003 |Medicinal product (product)| hierarchy in a future release. |
none292984002 |Ampicillin and cloxacillin adverse reaction - 430136001 |Adverse reaction caused by antiparkinsonism drug (disorder)|
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292267003 Benserazide + levodopa - Analgesic adverse reaction (disorder)|
Expected classification results |
: NEEDS INTERNAL AGREEMENT - further discussion needed with Drug Project Group re: expectations for classification(Agreed 21-Jan-2020): - Classification results are expected to reflect that the adverse reaction concepts are descendants of the appropriate disposition grouper based on the modeling of the 726542003 |Has disposition (attribute)| attribute in the substance hierarchy (e.g. 292113001 |Lansoprazole
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292984002 |Ampicillin and cloxacillin adverse reaction (disorder) will be modeled with Causative agent = 346320003 |Product containing ampicillin and cloxacillin (medicinal product)| and will have the the following inferred parents:292968003 |Ampicillin - adverse reaction (disorder)|
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with Causative agent = 387170002 |Ampicillin (substance)|292963007 |Cloxacillin - has inferred parent 292111004 |Proton pump inhibitor adverse reaction (disorder)|).
- Classification results are expected to be consistent with
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Causative agent = 373276005 |Cloxacillin - the modeling in the Substance hierarchy for concepts modeled with an attribute value from the Substance hierarchy.
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Structure grouper | yes | Adverse reaction concepts representing a structure grouper should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|. Example: |
292267003 |Benserazide + levodopa adverse reaction (disorder) will be modeled with Causative agent = 418467003 |Product containing benserazide and levodopa (medicinal product)| and will have the following inferred parents:- 218638005 |Adverse reaction caused by hydantoin derivative (disorder)|
- 419885006 |Beta lactam
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292266007 |Levodopa - adverse reaction (disorder)|
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with Causative agent = 387086006 |Levodopa (substance)|Note: There is not an existing concept for Adverse reaction to benserazide.Product | Medicinal product-only | no | none | No use case has been identified for use of this concept type for modeling in this subhierarchy. Medicinal product-containing concepts can be used for modeling in this subhierarchy. |
Product | Medicinal product form-containing | yes | none | Example: - 293543001 |Oral glyceryl trinitrate adverse reaction (disorder)
- 293545008 |Parenteral glyceryl trinitrate adverse reaction (disorder)
- 293546009 |Transdermal glyceryl trinitrate adverse reaction (disorder)
Expected classification results: NEEDS INTERNAL AGREEMENT - further discussion needed with Drug Project Group re: expectations for classification - 293543001 |Oral glyceryl trinitrate adverse reaction (disorder) will be modeled with Causative agent = 346460001 |Product containing glyceryl trinitrate in oral dose form (medicinal product form)| and will have the following inferred parents:
- 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|
- 293545008 |Parenteral glyceryl trinitrate adverse reaction (disorder) will be modeled with Causative agent = 346461002 |Product containing glyceryl trinitrate in parenteral dose form (medicinal product form)| and will have the following inferred parents:
- 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|
- 293546009 |Transdermal glyceryl trinitrate adverse reaction (disorder)
- 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|
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Product | Medicinal product form-only | no | none | No use case has been identified for use of this concept type for modeling in this subhierarchy. Medicinal product form-containing concepts can be used for modeling in this subhierarchy.
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Product | Clinical drug | no | none | No use case has been identified for use of this concept type for modeling in this subhierarchy.
Extension model may provide sufficient use case for this.Expected classification (Agreed 21-Jan-2020): - Classification results are expected to be consistent with the modeling in the Substance hierarchy and with other existing concepts in the subhierarchy.
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Descendant of 373873005 |Pharmaceutical / biologic product (product)| | no, unless documented as exception | Exceptions: None identified |
The following types of groupers are out of scope; existing concepts have been inactivated or will be addressed in future release:
- Groupers based on more than one role (e.g. 292722006 |Chelating agents and antidotes adverse reaction (disorder)|)
- Groupers based on body system or intended site or route of administration (e.g. 292548001 |Drug groups primarily affecting respiratory system adverse reaction (disorder)|) or 417895009 |Topical agent adverse reaction (disorder)|)
- Groupers based on disposition, role, or structure combined with an individual substance (e.g. 287177000 |Sulfonamide/trimethoprim reaction (disorder)| or 292513008 |Methyldopa and diuretic adverse reaction (disorder)|)
- Groupers based on "combined" or "compound" substances (e.g. 292983008 |Combined penicillin preparation adverse reaction (disorder)| or 293358005 |Compound iron preparations adverse reaction (disorder)|)
- Groupers based on disposition or structure combined with intended site or route of administration (e.g. 433494006 |Adverse effect of oral diphosphonate (disorder)|)
- Groupers based on disposition combined with role (e.g. 292265006 |Dopaminergic drug used in parkinsonism adverse reaction (disorder)|)
Rules for description generation:
- For the FSN, align terming and case sensitivity with the FSN for the concept that is selected as the attribute value, excluding the semantic tag.
- For the PT, align terming and case sensitivity with the US and GB PT for the concept that is selected as the attribute value.
- In cases where neither the US or GB PT matches the FSN, excluding the semantic tag, a synonym corresponding to the FSN is required unless explicitly identified as an exception.
- Additional synonyms "[agent] adverse reaction" should be added. Other synonyms are not allowed unless explicitly identified as an exception.
JIRA ticket for implementation: