TherapeuticRegimen

This element represents a therapeutic regimen which will involve a specified set of treatments for a particular condition. It can be thought of as a shorthand for a more specific set of treatments. This element is supposed to reference a more detailed regimen specification

Data model

TherapeuticRegimen

Definition of the TherapeuticRegimen element
Field Type Multiplicity Description
identifier {OntologyClass | ExternalReference} 1..1 An identifier for the regimen. REQUIRED.
start_time TimeElement 0..1 When the regimen was started. RECOMMENDED.
end_time TimeElement 0..1 When the regimen ended. An empty end_time with a populated start_time would indicate the regimen was ongoing. RECOMMENDED.
status RegimenStatus 1..1 Current status of the regimen for the enclosing MedicalAction on the Individual. REQUIRED.

RegimenStatus

Definition of the RegimenStatus enumeration
Name Ordinal Description
UNKNOWN_STATUS 0 The status of the regimen is unknown
STARTED 1 The regimen was started
COMPLETED 2 The regimen was completed
DISCONTINUED 3 The regimen was discontinued but not completed

Example

The following example describes twice daily dosing of 30 mg of losartan given orally.

therapeuticRegimen:
  externalReference:
    id: "NCT04576091"
    reference: "https://clinicaltrials.gov/ct2/show/NCT04576091"
    description: "Testing the Addition of an Anti-cancer Drug, BAY1895344, With Radiation\
      \ Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer"
  startTime:
    timestamp: "2020-03-15T13:00:00Z"
  regimenStatus: "STARTED"

Explanations

identifier

An OntologyClass or ExternalReference representing the therapeutic regimen which the subject (Individual) has followed.

start_time

When the regimen was started, as represented by a TimeElement.

end_time

When the regimen ended, as represented by a TimeElement.

regimen_status

The status of the regimen - whether it has started, completed or was discontinued. Regimens which were discontinued are RECOMMENDED to record any adverse events (MedicalAction.adverse_events) and the reason for termination (MedicalAction.treatment_termination_reason) in the enclosing MedicalAction message.