Common Data Models Harmonization, published by HL7 International - Biomedical Research and Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/cdmh/ and changes regularly. See the Directory of published versions
Defining URL: | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-adverseevent |
Version: | 1.0.0 |
Name: | CdmhAdverseEvent |
Title: | CDMH AdverseEvent |
Status: | Draft as of 9/1/19 |
Definition: | This is the AdverseEvent Resource profile for the IG. |
Publisher: | HL7 International - Biomedical Research and Regulation Work Group |
Copyright: | Used by permission of HL7, all rights reserved Creative Commons License |
Source Resource: | XML / JSON / Turtle |
The official URL for this profile is:
http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-adverseevent
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from AdverseEvent
Summary
Mandatory: 1 element
Must-Support: 12 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
This structure is derived from AdverseEvent
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | 0..* | AdverseEvent | CDMH AdverseEvent | |
id | Σ | 0..1 | string | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
cdmh-pcornet-death-source | S | 0..1 | code | PCORNetDeathSource URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-source Binding: PCORNet Death Source (extensible): Death Source Codes for PCORNet data marts |
cdmh-pcornet-death-match-confidence | S | 0..1 | code | PCORNetDeathMatchConfidence URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-match-confidence Binding: PCORNet Death Confidence Code (extensible): Death Match Confidence Codes for PCORNet data marts |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 0..1 | Identifier | Business identifier for the event |
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
category | Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. |
event | Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. |
subject | SΣ | 1..1 | Reference(CDMH Patient) | Subject impacted by event |
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of |
date | SΣ | 0..1 | dateTime | When the event occurred |
detected | Σ | 0..1 | dateTime | When the event was detected |
recordedDate | SΣ | 0..1 | dateTime | When the event was recorded |
resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event |
location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred |
seriousness | Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. |
severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. |
outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event |
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event |
suspectEntity | SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
instance | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
causality | SΣ | 0..* | BackboneElement | Information on the possible cause of the event |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
cdmh-pcornet-death-cause | S | 0..1 | string | Death Cause URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause |
cdmh-pcornet-death-cause-code | S | 0..1 | code | PCORNetDeathCauseCode URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-code Binding: PCORNet Death Cause Code (extensible): Death Cause Codes for PCORNet data marts |
cdmh-pcornet-death-cause-confidence | S | 0..1 | code | PCORNetDeathCauseConfidence URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-confidence Binding: PCORNet Death Confidence Code (extensible): Death Cause Confidence Codes for PCORNet data marts |
cdmh-pcornet-death-cause-type | S | 0..1 | code | PCORNetDeathCauseType URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-type Binding: PCORNet Death Cause Type (extensible): Death Cause Type Codes for PCORNet data marts |
cdmh-pcornet-death-cause-source | S | 0..1 | code | PCORNetDeathCauseSource URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-source Binding: PCORNet Death Source (extensible): Death Source Codes for PCORNet data marts |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event. |
productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor |
method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. |
subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory |
referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument |
study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
Documentation for this format |
This structure is derived from AdverseEvent
Summary
Mandatory: 1 element
Must-Support: 12 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Differential View
This structure is derived from AdverseEvent
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
AdverseEvent | 0..* | AdverseEvent | CDMH AdverseEvent | |
id | Σ | 0..1 | string | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
cdmh-pcornet-death-source | S | 0..1 | code | PCORNetDeathSource URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-source Binding: PCORNet Death Source (extensible): Death Source Codes for PCORNet data marts |
cdmh-pcornet-death-match-confidence | S | 0..1 | code | PCORNetDeathMatchConfidence URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-match-confidence Binding: PCORNet Death Confidence Code (extensible): Death Match Confidence Codes for PCORNet data marts |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 0..1 | Identifier | Business identifier for the event |
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
category | Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. |
event | Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event. |
subject | SΣ | 1..1 | Reference(CDMH Patient) | Subject impacted by event |
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of |
date | SΣ | 0..1 | dateTime | When the event occurred |
detected | Σ | 0..1 | dateTime | When the event was detected |
recordedDate | SΣ | 0..1 | dateTime | When the event was recorded |
resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event |
location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred |
seriousness | Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient. |
severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject. |
outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event |
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event |
suspectEntity | SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
instance | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
causality | SΣ | 0..* | BackboneElement | Information on the possible cause of the event |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
cdmh-pcornet-death-cause | S | 0..1 | string | Death Cause URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause |
cdmh-pcornet-death-cause-code | S | 0..1 | code | PCORNetDeathCauseCode URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-code Binding: PCORNet Death Cause Code (extensible): Death Cause Codes for PCORNet data marts |
cdmh-pcornet-death-cause-confidence | S | 0..1 | code | PCORNetDeathCauseConfidence URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-confidence Binding: PCORNet Death Confidence Code (extensible): Death Cause Confidence Codes for PCORNet data marts |
cdmh-pcornet-death-cause-type | S | 0..1 | code | PCORNetDeathCauseType URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-type Binding: PCORNet Death Cause Type (extensible): Death Cause Type Codes for PCORNet data marts |
cdmh-pcornet-death-cause-source | S | 0..1 | code | PCORNetDeathCauseSource URL: http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-pcornet-death-cause-source Binding: PCORNet Death Source (extensible): Death Source Codes for PCORNet data marts |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event. |
productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor |
method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. |
subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory |
referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument |
study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
Documentation for this format |
Other representations of profile: CSV, Excel, Schematron
Path | Conformance | ValueSet |
AdverseEvent.language | preferred | CommonLanguages Max Binding: AllLanguages |
AdverseEvent.actuality | required | AdverseEventActuality |
AdverseEvent.category | extensible | AdverseEventCategory |
AdverseEvent.event | example | SNOMEDCTClinicalFindings |
AdverseEvent.seriousness | example | AdverseEventSeriousness |
AdverseEvent.severity | required | AdverseEventSeverity |
AdverseEvent.outcome | required | AdverseEventOutcome |
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment |
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
Id | Path | Details | Requirements |
dom-2 | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | AdverseEvent.meta | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.implicitRules | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.language | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.text | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.extension:pcornet-death-source | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.extension:pcornet-death-source | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.extension:pcornet-death-match-confidence | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.extension:pcornet-death-match-confidence | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.identifier | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.actuality | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.category | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.event | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.subject | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.encounter | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.date | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.detected | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.recordedDate | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.resultingCondition | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.location | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.seriousness | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.severity | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.outcome | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.recorder | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.contributor | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.suspectEntity | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.suspectEntity.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.instance | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.suspectEntity.causality | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.suspectEntity.causality.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.causality.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause-code | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause-code | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause-confidence | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause-confidence | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause-type | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause-type | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause-source | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.causality.extension:pcornet-death-cause-source | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.causality.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | AdverseEvent.suspectEntity.causality.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ele-1 | AdverseEvent.suspectEntity.causality.assessment | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.suspectEntity.causality.productRelatedness | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.suspectEntity.causality.author | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.suspectEntity.causality.method | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.subjectMedicalHistory | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.referenceDocument | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ele-1 | AdverseEvent.study | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |