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.

regimen_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.