FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

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## Resource Profile: Oncologic Adverse Event

Official URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-adverse-event | Version: 1.1.0
Draft as of 2025-04-03 | Computable Name: OncoAdverseEvent

Adverse event related to a cancer-related treatment associated to a grade from MEDDRA terminology (ex: 10047700: "Vomiting").

Usage:

- Examples for this Resource Profile: AdverseEvent/fhir-osiris-example-adverseevent-1

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
Slices pour extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
extension:end-date | S | 0..1 | dateTime | End date URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. ele-1: All FHIR elements must have a @value or children
event | Σ | 1..1 | CodeableConcept | Term to describe the adverse event Binding: Adverse Event Code Value Set (extensible) ele-1: All FHIR elements must have a @value or children
subject | S Σ | 1..1 | Reference(Oncology Patient) | Subject impacted by event ele-1: All FHIR elements must have a @value or children
date | S Σ | 1..1 | dateTime | Date of diagnosis ele-1: All FHIR elements must have a @value or children
seriousness | S Σ | 1..1 | CodeableConcept | Grade of the adverse event Binding: Adverse Event Grade Value Set (required) ele-1: All FHIR elements must have a @value or children
suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event ele-1: All FHIR elements must have a @value or children
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
instance | S Σ | 1..1 | Reference(Oncology-related Medication Statement) | Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
subjectMedicalHistory | S Σ | 0..* | Reference(Tumor Pathology Event) | AdverseEvent.subjectMedicalHistory ele-1: All FHIR elements must have a @value or children
Documentation for this format

#### Terminology Bindings

Path | Conformité | ValueSet | URI
AdverseEvent.actuality | required | AdverseEventActuality `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` from the FHIR Standard
AdverseEvent.event | extensible | AdverseEventCode `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode` from this IG
AdverseEvent.seriousness | required | AdverseEventGrade `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade` from this IG

This structure is derived from AdverseEvent

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
Slices pour extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:end-date | S | 0..1 | dateTime | End date URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
event |  | 1..1 | CodeableConcept | Term to describe the adverse event Binding: Adverse Event Code Value Set (extensible)
subject | S | 1..1 | Reference(Oncology Patient) | Subject impacted by event
date | S | 1..1 | dateTime | Date of diagnosis
seriousness | S | 1..1 | CodeableConcept | Grade of the adverse event Binding: Adverse Event Grade Value Set (required)
coding |  |  |  |
code |  | 0..1 | code | Symbol in syntax defined by the system
suspectEntity |  |  |  |
instance | S | 1..1 | Reference(Oncology-related Medication Statement) | Refers to the specific entity that caused the adverse event
subjectMedicalHistory | S | 0..* | Reference(Tumor Pathology Event) | AdverseEvent.subjectMedicalHistory
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformité | ValueSet | URI
AdverseEvent.event | extensible | AdverseEventCode `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode` from this IG
AdverseEvent.seriousness | required | AdverseEventGrade `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade` from this IG

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
id | Σ | 0..1 | id | 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): A human language.
Bindings Additionnels | But
AllLanguages | Binding Max
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
Slices pour extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:end-date | S | 0..1 | dateTime | End date URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
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 | 1..1 | CodeableConcept | Term to describe the adverse event Binding: Adverse Event Code Value Set (extensible)
subject | S Σ | 1..1 | Reference(Oncology Patient) | Subject impacted by event
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of
date | S Σ | 1..1 | dateTime | Date of diagnosis
detected | Σ | 0..1 | dateTime | When the event was detected
recordedDate | Σ | 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 | S Σ | 1..1 | CodeableConcept | Grade of the adverse event Binding: Adverse Event Grade Value Set (required)
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
system | Σ | 0..1 | uri | Identity of the terminology system
version | Σ | 0..1 | string | Version of the system - if relevant
code | Σ | 0..1 | code | Symbol in syntax defined by the system
display | Σ | 0..1 | string | Representation defined by the system
userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user
text | Σ | 0..1 | string | Plain text representation of the concept
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 | Σ | 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 | S Σ | 1..1 | Reference(Oncology-related Medication Statement) | Refers to the specific entity that caused the adverse event
causality | Σ | 0..* | BackboneElement | Information on the possible cause of the 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
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 | S Σ | 0..* | Reference(Tumor Pathology Event) | AdverseEvent.subjectMedicalHistory
referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument
study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings

Path | Conformité | ValueSet | URI
AdverseEvent.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Bindings Additionnels | But
AllLanguages | Binding Max
AdverseEvent.actuality | required | AdverseEventActuality `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` from the FHIR Standard
AdverseEvent.category | extensible | AdverseEventCategory `http://hl7.org/fhir/ValueSet/adverse-event-category` from the FHIR Standard
AdverseEvent.event | extensible | AdverseEventCode `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode` from this IG
AdverseEvent.seriousness | required | AdverseEventGrade `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade` from this IG
AdverseEvent.severity | required | AdverseEventSeverity `http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1` from the FHIR Standard
AdverseEvent.outcome | required | AdverseEventOutcome `http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1` from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment `http://hl7.org/fhir/ValueSet/adverse-event-causality-assess` from the FHIR Standard
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod `http://hl7.org/fhir/ValueSet/adverse-event-causality-method` from the FHIR Standard

This structure is derived from AdverseEvent

Résumé

Mandatory: 3 elements
Must-Support: 6 elements

Structures

This structure refers to these other structures:

- Oncology Patient (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-patient)
- Oncology-related Medication Statement (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-medication-statement)
- Tumor Pathology Event (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/tumor-pathology-event)

Extensions

This structure refers to these extensions:

- https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date

Key Elements View

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
Slices pour extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
extension:end-date | S | 0..1 | dateTime | End date URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. ele-1: All FHIR elements must have a @value or children
event | Σ | 1..1 | CodeableConcept | Term to describe the adverse event Binding: Adverse Event Code Value Set (extensible) ele-1: All FHIR elements must have a @value or children
subject | S Σ | 1..1 | Reference(Oncology Patient) | Subject impacted by event ele-1: All FHIR elements must have a @value or children
date | S Σ | 1..1 | dateTime | Date of diagnosis ele-1: All FHIR elements must have a @value or children
seriousness | S Σ | 1..1 | CodeableConcept | Grade of the adverse event Binding: Adverse Event Grade Value Set (required) ele-1: All FHIR elements must have a @value or children
suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event ele-1: All FHIR elements must have a @value or children
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
instance | S Σ | 1..1 | Reference(Oncology-related Medication Statement) | Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
subjectMedicalHistory | S Σ | 0..* | Reference(Tumor Pathology Event) | AdverseEvent.subjectMedicalHistory ele-1: All FHIR elements must have a @value or children
Documentation for this format

#### Terminology Bindings

Path | Conformité | ValueSet | URI
AdverseEvent.actuality | required | AdverseEventActuality `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` from the FHIR Standard
AdverseEvent.event | extensible | AdverseEventCode `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode` from this IG
AdverseEvent.seriousness | required | AdverseEventGrade `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade` from this IG

Differential View

This structure is derived from AdverseEvent

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
Slices pour extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:end-date | S | 0..1 | dateTime | End date URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
event |  | 1..1 | CodeableConcept | Term to describe the adverse event Binding: Adverse Event Code Value Set (extensible)
subject | S | 1..1 | Reference(Oncology Patient) | Subject impacted by event
date | S | 1..1 | dateTime | Date of diagnosis
seriousness | S | 1..1 | CodeableConcept | Grade of the adverse event Binding: Adverse Event Grade Value Set (required)
coding |  |  |  |
code |  | 0..1 | code | Symbol in syntax defined by the system
suspectEntity |  |  |  |
instance | S | 1..1 | Reference(Oncology-related Medication Statement) | Refers to the specific entity that caused the adverse event
subjectMedicalHistory | S | 0..* | Reference(Tumor Pathology Event) | AdverseEvent.subjectMedicalHistory
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformité | ValueSet | URI
AdverseEvent.event | extensible | AdverseEventCode `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode` from this IG
AdverseEvent.seriousness | required | AdverseEventGrade `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade` from this IG

Snapshot View

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
id | Σ | 0..1 | id | 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): A human language.
Bindings Additionnels | But
AllLanguages | Binding Max
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
Slices pour extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:end-date | S | 0..1 | dateTime | End date URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
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 | 1..1 | CodeableConcept | Term to describe the adverse event Binding: Adverse Event Code Value Set (extensible)
subject | S Σ | 1..1 | Reference(Oncology Patient) | Subject impacted by event
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of
date | S Σ | 1..1 | dateTime | Date of diagnosis
detected | Σ | 0..1 | dateTime | When the event was detected
recordedDate | Σ | 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 | S Σ | 1..1 | CodeableConcept | Grade of the adverse event Binding: Adverse Event Grade Value Set (required)
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
system | Σ | 0..1 | uri | Identity of the terminology system
version | Σ | 0..1 | string | Version of the system - if relevant
code | Σ | 0..1 | code | Symbol in syntax defined by the system
display | Σ | 0..1 | string | Representation defined by the system
userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user
text | Σ | 0..1 | string | Plain text representation of the concept
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 | Σ | 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 | S Σ | 1..1 | Reference(Oncology-related Medication Statement) | Refers to the specific entity that caused the adverse event
causality | Σ | 0..* | BackboneElement | Information on the possible cause of the 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
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 | S Σ | 0..* | Reference(Tumor Pathology Event) | AdverseEvent.subjectMedicalHistory
referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument
study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings

Path | Conformité | ValueSet | URI
AdverseEvent.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Bindings Additionnels | But
AllLanguages | Binding Max
AdverseEvent.actuality | required | AdverseEventActuality `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` from the FHIR Standard
AdverseEvent.category | extensible | AdverseEventCategory `http://hl7.org/fhir/ValueSet/adverse-event-category` from the FHIR Standard
AdverseEvent.event | extensible | AdverseEventCode `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode` from this IG
AdverseEvent.seriousness | required | AdverseEventGrade `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade` from this IG
AdverseEvent.severity | required | AdverseEventSeverity `http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1` from the FHIR Standard
AdverseEvent.outcome | required | AdverseEventOutcome `http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1` from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment `http://hl7.org/fhir/ValueSet/adverse-event-causality-assess` from the FHIR Standard
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod `http://hl7.org/fhir/ValueSet/adverse-event-causality-method` from the FHIR Standard

This structure is derived from AdverseEvent

Résumé

Mandatory: 3 elements
Must-Support: 6 elements

Structures

This structure refers to these other structures:

- Oncology Patient (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-patient)
- Oncology-related Medication Statement (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-medication-statement)
- Tumor Pathology Event (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/tumor-pathology-event)

Extensions

This structure refers to these extensions:

- https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date

Other representations of profile: CSV, Excel, Schematron