| AdverseEventReporting UML Documentation |
AdverseEventReporting
Class RelevantPastDrugHistory
This class details "relevant drugs previously administered and which have been stopped before the Adverse Event onset. It does not concern drugs taken concomitantly or drugs which might have potentially been involved in the current reaction(s)/event(s). Medical judgment should be exercised in [determining which drug(s) to include]. Medications that have been stopped might be considered suspect based on the elimination half-life of the drug and the known pharmacodynamic effects of the drug in a particular patient (for example, a patient with known renal or liver impairment).... The information provided here can also include previous experience with similar drugs." - ICH E2B(R3), D.8.r.
Attributes |
«CS» Code | indication |
"The indication of the medicinal product." - ICH E2B(R3), D.8.r.6a and D.8.r.6b; D.10.8.r.6a and D.10.8.r.6b (MedDRA code and version)
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«EntryPoint» MedicationList | medicationList | |
«CS» Code | previousReaction |
"Describes previous experience with the drug described [in the medication list]" - ICH E2B(R3), D.8.r.7a and D.8.r.7b; D.10.8.r.7a and D.10.8.r.7b (MedDRA code and version)
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Properties:
Alias | |
Classifier Behavior | |
Is Abstract | false |
Is Active | false |
Is Leaf | false |
Keywords | |
Name | RelevantPastDrugHistory |
Name Expression | |
Namespace | AdverseEventReporting |
Owned Template Signature | |
Owner | AdverseEventReporting |
Owning Template Parameter | |
Package | AdverseEventReporting |
Qualified Name | FHIM::AdverseEventReporting::RelevantPastDrugHistory |
Representation | |
Stereotype | |
Template Parameter | |
Visibility | Public |
indication
Public «CS» Code indication
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"The indication of the medicinal product." - ICH E2B(R3), D.8.r.6a and D.8.r.6b; D.10.8.r.6a and D.10.8.r.6b (MedDRA code and version)
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Constraints:
-
Properties:
-
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | RelevantPastDrugHistory |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | indication |
Name Expression | |
Namespace | RelevantPastDrugHistory |
Opposite | |
Owner | RelevantPastDrugHistory |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::RelevantPastDrugHistory::indication |
Stereotype | |
Template Parameter | |
Type | «CS» Code |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
medicationList
Public «EntryPoint» MedicationList medicationList
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Constraints:
-
Properties:
-
Aggregation | None |
Alias | |
Association | (medicationList:MedicationList) |
Association End | |
Class | RelevantPastDrugHistory |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | medicationList |
Name Expression | |
Namespace | RelevantPastDrugHistory |
Opposite | |
Owner | RelevantPastDrugHistory |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::RelevantPastDrugHistory::medicationList |
Stereotype | |
Template Parameter | |
Type | «EntryPoint» MedicationList |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
previousReaction
Public «CS» Code previousReaction
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"Describes previous experience with the drug described [in the medication list]" - ICH E2B(R3), D.8.r.7a and D.8.r.7b; D.10.8.r.7a and D.10.8.r.7b (MedDRA code and version)
-
Constraints:
-
Properties:
-
Aggregation | None |
Alias | |
Association | |
Association End | |
Class | RelevantPastDrugHistory |
Datatype | |
Default | |
Default Value | |
Is Composite | false |
Is Derived | false |
Is Derived Union | false |
Is Leaf | false |
Is Ordered | false |
Is Read Only | false |
Is Static | false |
Is Unique | true |
Keywords | |
Lower | 0 |
Lower Value | (0) |
Multiplicity | 0..1 |
Name | previousReaction |
Name Expression | |
Namespace | RelevantPastDrugHistory |
Opposite | |
Owner | RelevantPastDrugHistory |
Owning Association | |
Owning Template Parameter | |
Qualified Name | FHIM::AdverseEventReporting::RelevantPastDrugHistory::previousReaction |
Stereotype | |
Template Parameter | |
Type | «CS» Code |
Upper | 1 |
Upper Value | (1) |
Visibility | Public |
| AdverseEventReporting UML Documentation |