MII IG Kerndatensatz-Modul Molekulares Tumorboard
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Beispiel Bundle: mii-exa-mtb-kim-musterperson-bundle

Language: de

Bundle mii-exa-mtb-kim-musterperson-bundle of type transaction

Entry 1 - fullUrl = http://example.org/fhir/ClinicalImpression/mii-exa-mtb-kim-musterperson-behandlungsepisode

Resso}:

Language: de

Profile: MII PR MTB Behandlungsepisode version: 2027.0.0-ballot.1

status: Completed

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-01-20 --> 2023-03-28

problem: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

investigation

code: Genetic finding

item: Diagnostic Report for 'Genetic analysis report' for '->Kim Musterperson (no stated gender), DoB: 1956-03-14'

investigation

code: Pathology synoptic report

item: Diagnostic Report for 'Pathology synoptic report' for '->Kim Musterperson (no stated gender), DoB: 1956-03-14'

investigation

code: ECOG performance status finding

item: Observation ECOG performance status

investigation

code: Was consent given

item: Observation Was consent given

supportingInfo:

Request:

PUT ClinicalImpression/mii-exa-mtb-kim-musterperson-behandlungsepisode

Entry 2 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-musterperson-aufklaerung

Resso}:

Language: de

Profile: MII PR MTB Consent version: 2027.0.0-ballot.1

status: Final

code: Was consent given

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-01-02

value: Yes (qualifier value)

Request:

PUT Observation/mii-exa-mtb-kim-musterperson-aufklaerung

Entry 3 - fullUrl = http://example.org/fhir/Patient/PatientKimMusterperson

Resso}:

Language: de

Kim Musterperson (no stated gender), DoB: 1956-03-14

Request:

PUT Patient/PatientKimMusterperson

Entry 4 - fullUrl = http://example.org/fhir/Observation/MTBObservationCA125-1

Resso}:

Language: de

status: Final

category: Laboratory studies (set), Laboratory

code: Cancer Ag 125 [Units/volume] in Body fluid

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2022-04-22

value: 42.3 IU/ml (Details: UCUM code[iU]/ml = '[iU]/ml')

Request:

PUT Observation/MTBObservationCA125-1

Entry 5 - fullUrl = http://example.org/fhir/Observation/MTBObservationCA125-2

Resso}:

Language: de

status: Final

category: Laboratory studies (set), Laboratory

code: Cancer Ag 125 [Units/volume] in Body fluid

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2022-07-18

value: 45.8 IU/ml (Details: UCUM code[iU]/ml = '[iU]/ml')

Request:

PUT Observation/MTBObservationCA125-2

Entry 6 - fullUrl = http://example.org/fhir/Observation/MTBObservationCA125-3

Resso}:

Language: de

status: Final

category: Laboratory studies (set), Laboratory

code: Cancer Ag 125 [Units/volume] in Body fluid

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2022-10-24

value: 49.7 IU/ml (Details: UCUM code[iU]/ml = '[iU]/ml')

Request:

PUT Observation/MTBObservationCA125-3

Entry 7 - fullUrl = http://example.org/fhir/Observation/MTBObservationCA125-4

Resso}:

Language: de

status: Final

category: Laboratory studies (set), Laboratory

code: Cancer Ag 125 [Units/volume] in Body fluid

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2022-12-27

value: 67.2 IU/ml (Details: UCUM code[iU]/ml = '[iU]/ml')

Request:

PUT Observation/MTBObservationCA125-4

Entry 8 - fullUrl = http://example.org/fhir/Observation/MTBObservationCA125-5

Resso}:

Language: de

status: Final

category: Laboratory studies (set), Laboratory

code: Cancer Ag 125 [Units/volume] in Body fluid

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-03-24

value: 43.7 IU/ml (Details: UCUM code[iU]/ml = '[iU]/ml')

Request:

PUT Observation/MTBObservationCA125-5

Entry 9 - fullUrl = http://example.org/fhir/Observation/MTBObservationCA125-6

Resso}:

Language: de

status: Final

category: Laboratory studies (set), Laboratory

code: Cancer Ag 125 [Units/volume] in Body fluid

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-06-20

value: 78.2 IU/ml (Details: UCUM code[iU]/ml = '[iU]/ml')

Request:

PUT Observation/MTBObservationCA125-6

Entry 10 - fullUrl = http://example.org/fhir/DiagnosticReport/PatientKimMusterperson-MolecularPathologyReport-1

Resso}:

Language: de

Profile: MII PR MTB Molecular Pathology Report version: 2027.0.0-ballot.1

Pathology synoptic report

SubjectKim Musterperson (no stated gender), DoB: 1956-03-14

Report Details

CodeValueFlags
HER2 Ag [Presence] in Tissue by Immune stain2+Final

Request:

PUT DiagnosticReport/PatientKimMusterperson-MolecularPathologyReport-1

Entry 11 - fullUrl = http://example.org/fhir/Specimen/PatientKimMusterperson-AscitesSpecimen-2

Resso}:

Language: de

Profile: MII PR Onkologie Specimen

accessionIdentifier: Z230201/23

type: Ascitic fluid specimen (specimen)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

Collections

-Collected[x]
*2023-02-01

Request:

PUT Specimen/PatientKimMusterperson-AscitesSpecimen-2

Entry 12 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-0a-Her2neu

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, Genetik, A characterization of a given biomarker observation.

code: HER2 Ag [Presence] in Tissue by Immune stain

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: 2+

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Components

-CodeValue[x]
*Gene studied [ID]ERBB2

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-0a-Her2neu

Entry 13 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyInterpret-0a-Her2neu

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: HER2 Ag [Interpretation] in Tissue

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: HER2-low (IHC 2+/ISH negative)

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Components

-CodeValue[x]
*Gene studied [ID]ERBB2

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyInterpret-0a-Her2neu

Entry 14 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-0b-Folat-Ra

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: Immune stain study

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: 70 % (Details: UCUM code{/100} = '{/100}')

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Components

-CodeValue[x]
*Gene studied [ID]FOLR1

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-0b-Folat-Ra

Entry 15 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-0c-Trop2

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: Immune stain study

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Positive

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Components

-CodeValue[x]
*Gene studied [ID]TACSTD2

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-0c-Trop2

Entry 16 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-1-CA125

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: Cancer Ag 125 [Presence] in Tissue by Immune stain

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Die Tumorzellen sind partiell positiv für CA125,...

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Components

-CodeValue[x]
*Gene studied [ID]TACSTD2

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-1-CA125

Entry 17 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-2-Pax8

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: PAX8 Ag [Presence] in Tissue by Immune stain

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Tumorzellen durchgehend nukleär für Pax 8

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-2-Pax8

Entry 18 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-3-WT1

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: Observation using immunohistochemistry (observable entity)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Tumorzellen durchgehend nukleär für WT1

bodySite: Nukleär

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Components

-CodeValue[x]
*Gene studied [ID]WT1

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-3-WT1

Entry 19 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-4-ER

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: Cells.estrogen receptor/cells in Tissue by Immune stain

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: 70 % (Details: UCUM code/100 = '/100')

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-4-ER

Entry 20 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-5-PR

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: Cells.progesterone receptor/cells in Tissue by Immune stain

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: 30 % (Details: UCUM code/100 = '/100')

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-5-PR

Entry 21 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-6-p53

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: P53 protein Ag [Presence] in Tissue by Immune stain

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Kräftige nukleäre Überexpression von p53

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-6-p53

Entry 22 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-MolecularPathologyObservation-7-p53

Resso}:

Language: de

Profile: MII PR MTB Immunohistochemistry version: 2027.0.0-ballot.1

status: Final

category: Laboratory, A characterization of a given biomarker observation.

code: P53 protein Ag [Presence] in Tissue by Immune stain

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Kräftige nukleäre Überexpression von p53

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Request:

PUT Observation/PatientKimMusterperson-MolecularPathologyObservation-7-p53

Entry 23 - fullUrl = http://example.org/fhir/Procedure/PatientKimMusterperson-Procedure-1

Resso}:

Language: de

Profile: MII PR Prozedur Procedure

status: Completed

category: Radiographic imaging procedure

code: Computertomographie [CT], nativ

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2022-04-20

bodySite: Abdomen, Thoracic structure

Request:

PUT Procedure/PatientKimMusterperson-Procedure-1

Entry 24 - fullUrl = http://example.org/fhir/Procedure/PatientKimMusterperson-Procedure-2

Resso}:

Language: de

Profile: MII PR Prozedur Procedure

status: Completed

category: Radiographic imaging procedure

code: Computertomographie [CT], nativ

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2022-07-15

bodySite: Abdomen, Thoracic structure

Request:

PUT Procedure/PatientKimMusterperson-Procedure-2

Entry 25 - fullUrl = http://example.org/fhir/Procedure/PatientKimMusterperson-Procedure-3

Resso}:

Language: de

Profile: MII PR Prozedur Procedure

status: Completed

category: Radiographic imaging procedure

code: Computertomographie [CT], nativ

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2022-10-22

bodySite: Abdomen, Thoracic structure

Request:

PUT Procedure/PatientKimMusterperson-Procedure-3

Entry 26 - fullUrl = http://example.org/fhir/Procedure/PatientKimMusterperson-Procedure-4

Resso}:

Language: de

Profile: MII PR Prozedur Procedure

status: Completed

category: Radiographic imaging procedure

code: Computertomographie [CT], nativ

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2022-12-19

bodySite: Abdomen, Thoracic structure

Request:

PUT Procedure/PatientKimMusterperson-Procedure-4

Entry 27 - fullUrl = http://example.org/fhir/Procedure/PatientKimMusterperson-Procedure-5

Resso}:

Language: de

Profile: MII PR Prozedur Procedure

status: Completed

category: Radiographic imaging procedure

code: Computertomographie [CT], nativ

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2023-03-20

bodySite: Abdomen, Thoracic structure

Request:

PUT Procedure/PatientKimMusterperson-Procedure-5

Entry 28 - fullUrl = http://example.org/fhir/Procedure/PatientKimMusterperson-Procedure-6

Resso}:

Language: de

Profile: MII PR Prozedur Procedure

status: Completed

category: Radiographic imaging procedure

code: Computertomographie [CT], nativ

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2023-08-20

bodySite: Abdomen, Thoracic structure

Request:

PUT Procedure/PatientKimMusterperson-Procedure-6

Entry 29 - fullUrl = http://example.org/fhir/Procedure/PatientKimMusterperson-Procedure-7

Resso}:

Language: de

Profile: MII PR Prozedur Procedure

status: Completed

category: Radiographic imaging procedure

code: Computertomographie [CT], nativ

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2023-10-22

bodySite: Abdomen, Thoracic structure

Request:

PUT Procedure/PatientKimMusterperson-Procedure-7

Entry 30 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-1

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Metastatic malignant neoplasm (disorder)

value: kein Hinweis auf thorakale Metastasierung

Request:

PUT Observation/PatientKimMusterperson-Observation-1

Entry 31 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-2

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Recurrent

value: kein Hinweis auf Lokalrezidiv

Request:

PUT Observation/PatientKimMusterperson-Observation-2

Entry 32 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-3

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Ascites

value: kein Aszites

Request:

PUT Observation/PatientKimMusterperson-Observation-3

Entry 33 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-4

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Status post (contextual qualifier) (qualifier value)

value: Flüssigkeitskollektion angrenzend DD postoperativ

bodySite: Entire duodenum

Request:

PUT Observation/PatientKimMusterperson-Observation-4

Entry 34 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-5

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Status post (contextual qualifier) (qualifier value)

value: konstante Flüssigkeitskollektion angrenzend

bodySite: Entire duodenum

Request:

PUT Observation/PatientKimMusterperson-Observation-5

Entry 35 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-6

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Ascites

value: kein Aszites

Request:

PUT Observation/PatientKimMusterperson-Observation-6

Entry 36 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-7

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Recurrent

value: kein Hinweis auf Lokalrezidiv

Request:

PUT Observation/PatientKimMusterperson-Observation-7

Entry 37 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-8

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: im linken Oberlappen der Lunge diskrete milchglasartige Trübung

value: kein Hinweis auf thorakale Filiae

Request:

PUT Observation/PatientKimMusterperson-Observation-8

Entry 38 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-9

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Status post (contextual qualifier) (qualifier value)

value: regrediente Flüssigkeitskollektion am Leberrand

bodySite: Entire liver

Request:

PUT Observation/PatientKimMusterperson-Observation-9

Entry 39 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-10

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Status post (contextual qualifier) (qualifier value)

value: Darüberhinaus kein Hinweis auf Leberfilialisierung.

bodySite: Entire liver

Request:

PUT Observation/PatientKimMusterperson-Observation-10

Entry 40 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-11

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Ascites

value: kein Aszites

Request:

PUT Observation/PatientKimMusterperson-Observation-11

Entry 41 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-12

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Recurrent

value: kein Hinweis auf Lokalrezidiv

Request:

PUT Observation/PatientKimMusterperson-Observation-12

Entry 42 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-13

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: regrediente Milchglasinfiltrate im linken Oberlappen

value: a.e. atypisch entzündlich

Request:

PUT Observation/PatientKimMusterperson-Observation-13

Entry 43 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-14

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: mediastinaler Lymphknoten

value: vermehrter mediastinaler Lymphknotenbesatz ohne Kontrastmittelaufnahme

Request:

PUT Observation/PatientKimMusterperson-Observation-14

Entry 44 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-15

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: mediastinaler Lymphknoten

value: ohne pathologische Vergrößerung

Request:

PUT Observation/PatientKimMusterperson-Observation-15

Entry 45 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-16

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Progredienter Aszites

value: 700 ml (Details: UCUM codemL = 'mL')

Request:

PUT Observation/PatientKimMusterperson-Observation-16

Entry 46 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-17

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Peritonealblatt

value: Peritonealblatt mit zunehmender, unregelmäßiger KM-Aufnahme

Request:

PUT Observation/PatientKimMusterperson-Observation-17

Entry 47 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-18

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Peritonealkarzinose

value: Progress

Request:

PUT Observation/PatientKimMusterperson-Observation-18

Entry 48 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-19

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: kleinen Becken

value: Lokalrezidiv bei kontrastmittelaufnehmender Raumforderung

Request:

PUT Observation/PatientKimMusterperson-Observation-19

Entry 49 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-20

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Aszites

value: Regredient

Request:

PUT Observation/PatientKimMusterperson-Observation-20

Entry 50 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-21

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: im kleinen Becken

value: rückläufige KM-Aufnahme der lokalrezidivsuspekten Raumforderung

Request:

PUT Observation/PatientKimMusterperson-Observation-21

Entry 51 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-22

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: zahlenmäßig vermehrten LK im Mediastinum

value: noch flaue, aber insgesamt regrediente KM-Aufnhame

Request:

PUT Observation/PatientKimMusterperson-Observation-22

Entry 52 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-23

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Läsion

value: keine neue

Request:

PUT Observation/PatientKimMusterperson-Observation-23

Entry 53 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-24

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Ascites

value: kein Aszites

Request:

PUT Observation/PatientKimMusterperson-Observation-24

Entry 54 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-25

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: Lokalrezidiv

value: regredientes Lokalrezidiv ohne KM-Aufnahme im kleinen Becken

Request:

PUT Observation/PatientKimMusterperson-Observation-25

Entry 55 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-26

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: kleinen Becken

value: geringer Aszites

Request:

PUT Observation/PatientKimMusterperson-Observation-26

Entry 56 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-27

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: vormals KM-aufnehmendes Lokalrezidiv im kleinen Becken

value: aktuell metrisch nur noch schwer fassbar

bodySite: True pelvis

Request:

PUT Observation/PatientKimMusterperson-Observation-27

Entry 57 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-29

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: mediastinale Lymphknoten

value: formal noch vermehrte

Request:

PUT Observation/PatientKimMusterperson-Observation-29

Entry 58 - fullUrl = http://example.org/fhir/Observation/PatientKimMusterperson-Observation-30

Resso}:

Language: de

partOf: Procedure Computertomographie [CT], nativ

status: Final

code: mediastinale Lymphknoten

value: nicht mehr KM-aufnehmende

Request:

PUT Observation/PatientKimMusterperson-Observation-30

Entry 59 - fullUrl = http://example.org/fhir/ClinicalImpression/MII-EXA-MTB-Follow-Up-ClinicalImpression-1

Resso}:

Language: de

Profile: MII PR MTB Clinical Impresssion version: 2027.0.0-ballot.1

status: Completed

code: Follow-up encounter (procedure)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-10-22

previous: ClinicalImpression: status = completed; effective[x] = 2023-01-20 --> 2023-03-28

Investigations

-Code
*completed

supportingInfo:

Request:

PUT ClinicalImpression/MII-EXA-MTB-Follow-Up-ClinicalImpression-1

Entry 60 - fullUrl = http://example.org/fhir/Procedure/MII-EXA-MTB-Systemische-Therapie-1

Resso}:

Language: de

Profile: MII PR MTB Systemische Therapie version: 2027.0.0-ballot.1

MII EX Onko Systemische Therapie Intention: kurativ

basedOn: CarePlan: status = active; intent = plan; category = prätherapeutische Tumorkonferenz (Festlegung der Therapiestrategie); created = 2023-03-28

status: Completed

statusReason: regular-completion

category: Chemotherapy (procedure)

code: Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2023-06-24 --> 2023-10-12

Request:

PUT Procedure/MII-EXA-MTB-Systemische-Therapie-1

Entry 61 - fullUrl = http://example.org/fhir/MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-1

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-06-24 --> 2023-06-24

note:

24.06.2023 Z1 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-06-24

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-1

Entry 62 - fullUrl = http://example.org/fhir/MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-2

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

status: Completed

statusReason: E

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-07-16 --> 2023-07-16

note:

16.07.2023 Z2 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-07-16

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-2

Entry 63 - fullUrl = http://example.org/fhir/MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-3

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

status: Completed

statusReason: E

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-08-07 --> 2023-08-07

note:

07.08.2023 Z3 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-08-07

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-3

Entry 64 - fullUrl = http://example.org/fhir/MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-4

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-08-29 --> 2023-08-29

note:

29.08.2023 Z4 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-08-29

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-4

Entry 65 - fullUrl = http://example.org/fhir/MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-5

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

status: Completed

statusReason: E

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-09-20 --> 2023-09-20

note:

20.09.2023 Z2 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-09-20

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-5

Entry 66 - fullUrl = http://example.org/fhir/MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-6

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-10-12 --> 2023-10-12

note:

12.10.2023 Z3 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-10-12

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MII-EXA-MTB-Systemische-Therapie-Medication-6

Entry 67 - fullUrl = http://example.org/fhir/Observation/MII-EXA-MTB-Response-Befund-1

Resso}:

Language: de

Profile: MII PR MTB Response Befund version: 2027.0.0-ballot.1

partOf: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

status: Final

code: Status of regression of tumor (observable entity)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

focus: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

effective: 2023-08-20

value: Complete Response

method: RECIST

Components

-CodeValue[x]
*Presence of metastatic neoplasm in regional lymph node (observable entity)kein Lymphknotenbefall nachweisbar

Request:

PUT Observation/MII-EXA-MTB-Response-Befund-1

Entry 68 - fullUrl = http://example.org/fhir/Observation/MII-EXA-MTB-Response-Befund-2

Resso}:

Language: de

Profile: MII PR MTB Response Befund version: 2027.0.0-ballot.1

partOf: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie

status: Final

code: Status of regression of tumor (observable entity)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

focus: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

effective: 2023-10-22

value: Partial Response

method: RECIST

Components

-CodeValue[x]
*Presence of metastatic neoplasm in regional lymph node (observable entity)kein Lymphknotenbefall nachweisbar

Request:

PUT Observation/MII-EXA-MTB-Response-Befund-2

Entry 69 - fullUrl = http://example.org/fhir/Claim/MII-EXA-MTB-Antrag-Kostenuebernahme-1

Resso}:

Language: de

Profile: MII PR MTB Antrag Kostenuebernahme version: 2027.0.0-ballot.1

status: Active

type: institutional

use: Claim

patient: Kim Musterperson (no stated gender), DoB: 1956-03-14

created: 2023-03-10

provider: Organization Example General Hospital

priority: Normal

Relateds

-Relationship
*initial-claim

prescription: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

CareTeams

-SequenceProviderResponsible
*1Organization Example Health Insurance Co.true

Insurances

-SequenceFocalCoverageClaimResponse
*1trueCoverage: status = active; type = extended healthcare; period = 2023-01-01 --> 2025-12-31ClaimResponse: status = active; type = institutional; use = claim; created = 2023-05-01; outcome = complete

Request:

PUT Claim/MII-EXA-MTB-Antrag-Kostenuebernahme-1

Entry 70 - fullUrl = http://example.org/fhir/ClaimResponse/MII-EXA-MTB-Antwort-Kostenuebernahme-1

Resso}:

Language: de

Profile: MII PR MTB Anwort Kostenuebernahme version: 2027.0.0-ballot.1

status: Active

type: institutional

use: Claim

patient: Kim Musterperson (no stated gender), DoB: 1956-03-14

created: 2023-05-01

insurer: Organization Example General Hospital

request: Claim: status = active; type = institutional; use = claim; created = 2023-03-10; priority = Normal

outcome: Processing Complete

Request:

PUT ClaimResponse/MII-EXA-MTB-Antwort-Kostenuebernahme-1

Entry 71 - fullUrl = http://example.org/fhir/Specimen/PatientKimMusterperson-Specimen-1

Resso}:

Language: de

Profile: MII PR Patho Specimen

identifier: Z 230201/23

accessionIdentifier: Z 230201/23

status: Available

type: Ascitic fluid specimen

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

Collections

-Collected[x]QuantityMethod
*2023-01-0220 mL (Details: UCUM codemL = 'mL')Percutaneous drainage of ascites

Request:

PUT Specimen/PatientKimMusterperson-Specimen-1

Entry 72 - fullUrl = http://example.org/fhir/Procedure/MTBChemo1Procedure

Resso}:

Language: de

Profile: MII PR MTB Systemische Vortherapie version: 2027.0.0-ballot.1

MII EX Onko Systemische Therapie Intention: kurativ

status: Completed

category: Therapeutic procedure

code: Chemotherapy

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2023-01-04 --> 2023-05-24

outcome: Reguläres Ende mit Substanzwechsel

Request:

PUT Procedure/MTBChemo1Procedure

Entry 73 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement1

Resso}:

partOf: Procedure Chemotherapy

status: Completed

medication: Z1 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-01-04

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement1

Entry 74 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement1-1

Resso}:

partOf:

status: Completed

medication: Carboplatin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-01-04

note:

Z1 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-01-04

DoseAndRates

-Dose[x]
*5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement1-1

Entry 75 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement1-2

Resso}:

partOf:

status: Completed

medication: Doxorubicin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-01-04

note:

Z1 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-01-04

DoseAndRates

-Dose[x]
*30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement1-2

Entry 76 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement2

Resso}:

partOf: Procedure Chemotherapy

status: Completed

medication: Z2 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-02-01

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement2

Entry 77 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement2-1

Resso}:

partOf:

status: Completed

medication: Carboplatin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-02-01

note:

Z2 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-02-01

DoseAndRates

-Dose[x]
*5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement2-1

Entry 78 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement2-2

Resso}:

partOf:

status: Completed

medication: Doxorubicin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-02-01

note:

Z2 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-02-01

DoseAndRates

-Dose[x]
*30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement2-2

Entry 79 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement3

Resso}:

partOf: Procedure Chemotherapy

status: Completed

medication: Z3 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-03-01

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement3

Entry 80 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement3-1

Resso}:

partOf:

status: Completed

medication: Carboplatin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-03-01

note:

Z3 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-03-01

DoseAndRates

-Dose[x]
*5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement3-1

Entry 81 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement3-2

Resso}:

partOf:

status: Completed

medication: Doxorubicin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-03-01

note:

Z3 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-03-01

DoseAndRates

-Dose[x]
*30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement3-2

Entry 82 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement4

Resso}:

partOf: Procedure Chemotherapy

status: Completed

medication: Z4 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-03-29

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement4

Entry 83 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement4-1

Resso}:

partOf:

status: Completed

medication: Carboplatin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-03-29

note:

Z4 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-03-29

DoseAndRates

-Dose[x]
*5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement4-1

Entry 84 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement4-2

Resso}:

partOf:

status: Completed

medication: Doxorubicin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-03-29

note:

Z4 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-03-29

DoseAndRates

-Dose[x]
*30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement4-2

Entry 85 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement5

Resso}:

partOf: Procedure Chemotherapy

status: Completed

medication: Z5 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-04-26

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement5

Entry 86 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement5-1

Resso}:

partOf:

status: Completed

medication: Carboplatin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-04-26

note:

Z5 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-04-26

DoseAndRates

-Dose[x]
*5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement5-1

Entry 87 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement5-2

Resso}:

partOf:

status: Completed

medication: Doxorubicin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-04-26

note:

Z5 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-04-26

DoseAndRates

-Dose[x]
*30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement5-2

Entry 88 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement6

Resso}:

partOf: Procedure Chemotherapy

status: Completed

medication: Z6 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-05-24

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement6

Entry 89 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement6-1

Resso}:

partOf:

status: Completed

medication: Carboplatin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-05-24

note:

Z6 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-05-24

DoseAndRates

-Dose[x]
*5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement6-1

Entry 90 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo1MedicationStatement6-2

Resso}:

partOf:

status: Completed

medication: Doxorubicin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-05-24

note:

Z6 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1

dosage

timing: Events: 2023-05-24

DoseAndRates

-Dose[x]
*30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')

Request:

PUT MedicationStatement/MTBChemo1MedicationStatement6-2

Entry 91 - fullUrl = http://example.org/fhir/Procedure/MTBChemo2Procedure

Resso}:

Language: de

Profile: MII PR MTB Systemische Vortherapie version: 2027.0.0-ballot.1

MII EX Onko Systemische Therapie Intention: kurativ

basedOn: CarePlan: status = active; intent = plan; category = prätherapeutische Tumorkonferenz (Festlegung der Therapiestrategie); created = 2023-03-28

status: Completed

category: Therapeutic procedure

code: Chemotherapy

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

performed: 2023-06-24 --> 2023-10-12

outcome: Reguläres Ende

Request:

PUT Procedure/MTBChemo2Procedure

Entry 92 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo2MedicationStatement1

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Chemotherapy

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-06-24

note:

Z1 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-06-24

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MTBChemo2MedicationStatement1

Entry 93 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo2MedicationStatement2

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Chemotherapy

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-07-16

note:

Z2 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-07-16

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MTBChemo2MedicationStatement2

Entry 94 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo2MedicationStatement3

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Chemotherapy

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-08-07

note:

Z3 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-08-07

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MTBChemo2MedicationStatement3

Entry 95 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo2MedicationStatement4

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Chemotherapy

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-08-29

note:

Z4 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-08-29

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MTBChemo2MedicationStatement4

Entry 96 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo2MedicationStatement5

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Chemotherapy

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-09-20

note:

Z5 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-09-20

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MTBChemo2MedicationStatement5

Entry 97 - fullUrl = http://example.org/fhir/MedicationStatement/MTBChemo2MedicationStatement6

Resso}:

basedOn: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

partOf: Procedure Chemotherapy

status: Completed

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2023-10-12

note:

Z6 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22

dosage

timing: Events: 2023-10-12

DoseAndRates

-Dose[x]
*6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')

Request:

PUT MedicationStatement/MTBChemo2MedicationStatement6

Entry 98 - fullUrl = http://example.org/fhir/DiagnosticReport/mii-exa-mtb-kim-musterperson-ngs-bericht

Resso}:

Language: de

Profile: MII PR MTB NGS-Bericht version: 2027.0.0-ballot.1

Genetic analysis report (Genetics)

SubjectKim Musterperson (no stated gender), DoB: 1956-03-14
Reported2023-03-28 00:00:00+0000

Report Details

CodeValueFlags
Genetic variant assessmentPresentFinal
Genetic variant assessmentPresentFinal
Genetic variant assessmentPresentFinal

Request:

PUT DiagnosticReport/mii-exa-mtb-kim-musterperson-ngs-bericht

Entry 99 - fullUrl = http://example.org/fhir/Procedure/mii-exa-mtb-kim-musterperson-genomic-study

Resso}:

Language: de

Profile: MII PR MTB Genomic Study version: 2027.0.0-ballot.1

Genomic Study Analysis Extension: Procedure: extension = Next-Generation (NGS)/Massively parallel sequencing (MPS),SNV,SNV,GRCh38; status = completed; category = Laboratory

Genomic Study Analysis Extension: Procedure: status = completed; category = Laboratory

Genomic Study Analysis Extension: Procedure: extension = Immunohistochemistry; status = completed; category = Laboratory

status: Completed

category: Laboratory

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

Request:

PUT Procedure/mii-exa-mtb-kim-musterperson-genomic-study

Entry 100 - fullUrl = http://example.org/fhir/Procedure/mii-exa-mtb-kim-musterperson-genomic-study-analysis-1

Resso}:

Language: de

Profile: MII PR MTB Genomic Study Analysis version: 2027.0.0-ballot.1

Genomic Study Analysis Method Type: Next-Generation (NGS)/Massively parallel sequencing (MPS)

Genomic Study Analysis Change Type: SNV

Genomic Study Analysis Genome Build: GRCh38

status: Completed

category: Laboratory

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

Request:

PUT Procedure/mii-exa-mtb-kim-musterperson-genomic-study-analysis-1

Entry 101 - fullUrl = http://example.org/fhir/Procedure/mii-exa-mtb-kim-musterperson-genomic-study-analysis-2

Resso}:

Language: de

Profile: MII PR MTB Genomic Study Analysis version: 2027.0.0-ballot.1

status: Completed

category: Laboratory

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

Request:

PUT Procedure/mii-exa-mtb-kim-musterperson-genomic-study-analysis-2

Entry 102 - fullUrl = http://example.org/fhir/Procedure/mii-exa-mtb-kim-musterperson-genomic-study-analysis-3

Resso}:

Language: de

Profile: MII PR MTB Genomic Study Analysis version: 2027.0.0-ballot.1

Genomic Study Analysis Method Type: Immunohistochemistry

status: Completed

category: Laboratory

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

Request:

PUT Procedure/mii-exa-mtb-kim-musterperson-genomic-study-analysis-3

Entry 103 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-musterperson-EinfacheVariante-TP53

Resso}:

Language: de

Profile: MII PR MTB Einfache Variante version: 2027.0.0-ballot.1

status: Final

category: Laboratory, Genetik

code: Genetic variant assessment

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Present

component

code: Gene studied [ID]

value: TP53

component

code: Amino acid change (pHGVS)

value: NP_000537.3:p.Arg213Ter

Request:

PUT Observation/mii-exa-mtb-kim-musterperson-EinfacheVariante-TP53

Entry 104 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-musterperson-DiagnostischeImplikation-TP53

Resso}:

Language: de

Profile: MII PR MTB Diagnostische Implikation version: 2027.0.0-ballot.1

status: Final

category: Laboratory, Genetik

code: Diagnostic Implication

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

derivedFrom: Observation Genetic variant assessment

Components

-CodeValue[x]
*Genetic variation clinical significance [Imp]Pathogenic

Request:

PUT Observation/mii-exa-mtb-kim-musterperson-DiagnostischeImplikation-TP53

Entry 105 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-musterperson-EinfacheVariante-PIK3R1

Resso}:

Language: de

Profile: MII PR MTB Einfache Variante version: 2027.0.0-ballot.1

status: Final

category: Laboratory, Genetik

code: Genetic variant assessment

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Present

component

code: Gene studied [ID]

value: PIK3R1

component

code: Amino acid change (pHGVS)

value: NP_852664.1:p.(Glu160Ter)

Request:

PUT Observation/mii-exa-mtb-kim-musterperson-EinfacheVariante-PIK3R1

Entry 106 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-musterperson-TherapeutischeImplikation-PIK3R1

Resso}:

Language: de

Profile: MII PR MTB Therapeutische Implikation version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Evidenzgraduierung: m3

status: Final

category: Laboratory, Genetik

code: Therapeutic Implication

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

derivedFrom: Observation Genetic variant assessment

component

code: Conclusion Text

value: Ausweislich praeklinischer Daten liegt ein Ansprechen auf MEK-Inhibition nahe (PMID: 31209687, EL m3).

component

code: Medication assessed [ID]

value: Mitogen-aktivierte Proteinkinase (MEK)-Inhibitoren

Request:

PUT Observation/mii-exa-mtb-kim-musterperson-TherapeutischeImplikation-PIK3R1

Entry 107 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-musterperson-CNVariante-CCNE1

Resso}:

Language: de

Profile: MII PR MTB Copy Number Variant version: 2027.0.0-ballot.1

status: Final

category: Laboratory, Genetik

code: Genetic variant assessment

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Present

component

code: Gene studied [ID]

value: CCNE1

component

code: type

value: high-level-gain

component

code: Genomic structural variant copy number

value: 7 1 (Details: UCUM code1 = '1')

Request:

PUT Observation/mii-exa-mtb-kim-musterperson-CNVariante-CCNE1

Entry 108 - fullUrl = http://example.org/fhir/ServiceRequest/mii-exa-mtb-study-request-cldn6

Resso}:

Language: de

Profile: MII PR MTB Studieneinschluss Anfrage version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Priorität: 2.1

MII EX MTB Empfehlung Publikation: http://www.ncbi.nlm.nih.gov/pubmed/37872225

status: Draft

intent: Proposal

category: Clinical trial (procedure)

code: Referral to clinical trial (procedure)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

supportingInfo: ResearchStudy: identifier = https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct#MII_NS_MTB_NCT#04503278; status = active; primaryPurposeType = treatment; phase = phase-1; condition = Solid tumor configuration; keyword = ; period = 2020-09-16 --> 2040-01

Request:

PUT ServiceRequest/mii-exa-mtb-study-request-cldn6

Entry 109 - fullUrl = http://example.org/fhir/ResearchStudy/mii-exa-mtb-study-cldn6

Resso}:

Language: de

Profile: MII PR MTB Studie version: 2027.0.0-ballot.1

identifier: MII_NS_MTB_NCT/04503278

status: Active

primaryPurposeType: treatment

phase: phase-1

condition: Solid tumor configuration

keyword: Non-small cell lung cancer (NSCLC)

enrollment: Group: type = person; actual = false; quantity = 145

period: 2020-09-16 --> 2040-01

sponsor: Organization BioNTech Cell & Gene Therapies GmbH

principalInvestigator: PractitionerRole Study coordinator

site: Location Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska Universitetssjukhuset

arm

name: Part 1 - CLDN6 CAR-T: Dose escalation in lymphodepleted patients until the MTD and/or RP2D

arm

name: Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX: Dose escalation until the MTD and/or RP2D

objective

name: Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship

type: primary

objective

name: Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs

type: primary

objective

name: Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period

type: primary

objective

name: Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay

type: secondary

objective

name: Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per response evaluation criteria in solid tumors [RECIST 1.1]) is observed as best overall response

type: secondary

objective

name: Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response

type: secondary

objective

name: Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective progressive disease (PD) per RECIST 1.1/recurrence or death from any cause, whichever occurs first

type: secondary

Request:

PUT ResearchStudy/mii-exa-mtb-study-cldn6

Entry 110 - fullUrl = http://example.org/fhir/Group/mii-exa-mtb-study-cldn6-eligibility-criteria

Resso}:

Language: de

type: Person

actual: false

quantity: 145

characteristic

code: Eligibility Criteria

value: Inclusion Criteria: * Each patient enrolled in the trial must have CLDN6-positive tumor regardless of tumor histology defined as ≥ 50% of tumor cells expressing ≥ 2+ CLDN6 protein using a semi-quantitative immunohistochemistry (IHC) assay in a central laboratory for specific detection of CLDN6 protein expression in formalin-fixed, paraffin-embedded (FFPE) neoplastic tissues. * Availability of a FFPE tumor tissue sample. FFPE can be from an archival tumor tissue sample, and it should be from the most recent tumor tissue obtained. If this is not available, patient must be biopsied for CLDN6 staining. * Must have histological documentation of the original primary tumor via a pathology report. * Must have measurable disease per RECIST 1.1 (except for germ cell tumors, where patients can be evaluated according to Cancer-Antigen (CA)-125, Alpha-fetoprotein or human chorionic gonadotropin \[as applicable\] or ovarian cancer, where patients can be evaluated according to CA-125. The pre-treatment sample must be at least twice the upper limit of normal). * Must have a histologically confirmed solid tumor that is metastatic or unresectable and for which there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy. * Must be ≥ 18 years of age at the time the pre-screening informed consent is signed. * Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the trial and are willing to participate in the trial prior to any trial-related assessments or procedures. * Must have an Eastern Cooperative Oncology Group performance status of 0 to 1. * Must have adequate coagulation function at screening as defined in the protocol. * Must have adequate hematologic function at screening as defined in the protocol. * Must have adequate hepatic function at screening as defined in the protocol. * Must have adequate renal function at screening as defined in the protocol. * Must be able to attend trial visits as required by the protocol. * Women of childbearing potential (WOCBP) must have a negative serum (beta-human chorionic gonadotropin) test/value at screening. Patients who are post-menopausal or permanently sterilized can be considered as not having reproductive potential. * WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and thereafter. * WOCBP and men that are sexually active with a WOCBP and have not had a vasectomy must agree to use highly effective birth control method(s), as defined in the protocol. True abstinence is an acceptable alternative to the use of contraception. * Men must agree not to father a child or donate sperm, and WOCBP must agree not to become pregnant during the trial and for at least 12 months after the CLDN6 CAR-T infusion or CLDN6 RNA-LPX treatment. For Part 2 only: * Histologically or cytologically confirmed solid tumor fulfilling inclusion criteria 1-4 that is metastatic or unresectable, and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy. Exclusion Criteria: * Has received prior CAR-T therapy, except CLDN6 CAR-T therapy. * Has received vaccination with live virus vaccines within 6 weeks prior to the start of lymphodepletion (LD). * Receives concurrent systemic (oral or i.v.) steroid therapy \> 10 mg prednisolone daily, or its equivalent, for an underlying condition. * Has side effects of any prior therapy or procedures for any medical condition not recovered to national cancer institute common terminology criteria for adverse events (CTCAE v.5) Grade ≤ 1. Medical conditions: * Current evidence of new or growing brain or spinal metastases during screening. Patients with known brain or spinal metastases may be eligible if they: 1. Have had radiotherapy or another appropriate therapy for the brain or spinal metastases, 2. Have no neurological symptoms, 3. Have stable brain or spinal disease on the computer tomography or magnetic resonance imaging scan within 4 weeks before signing of the ICF, 4. Are not undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for the last 14 days prior to screening (≤ 10 mg prednisolone daily or equivalent), 5. Do not require steroid therapy within 7 days before the first dose of CLDN6 CAR-T, 6. Do not have anticipated imminent fracture or cord compression due to spinal bone metastases. * Has history of epilepsy. Isolated seizures in the past or febrile seizures in childhood are permitted; has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago. * Pericardial effusion requiring any drainage is excluded. * Has an active autoimmune disease including but not limited to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Has any active immunologic disorder requiring immunosuppression with steroids or other immunosuppressive agents with the exception of patients with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and euthyroid patients with a history of Grave's disease. Patients with controlled hyperthyroidism must be negative for thyroglobulin, thyroid peroxidase antibodies, and thyroid-stimulating immunoglobulin prior to trial drug administration. * Seropositivity for human immunodeficiency virus. * Known history/positive serology for hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy). Patients with positive serology must have hepatitis B virus viral load below the limit of quantification. * Active hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed. * Has a known hypersensitivity to a component of CLDN6 CAR-T or CLDN6 RNA-LPX cancer vaccine drug product, or another similar compound. * Only for patients recruited for Part 2 with LD chemotherapy (CLDN6 CAR-T + CLDN6 RNA-LPX with LD chemotherapy): history of severe immediate hypersensitivity reaction to LD chemotherapy consisting of cyclophosphamide or fludarabine. * Has a history of another primary cancer within the 2 years prior to enrollment except for the following: Non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, prostate cancer with currently undetectable prostate specific antigen, or other non-metastatic carcinoma that has been in complete remission without treatment for more than 2 years. * Receipt of allogenic stem cell transplantation in the 5 years prior to enrollment into the trial. * Patients with acute or chronic graft versus host disease. Other comorbidities: * Has abnormal electrocardiograms that are clinically significant, such as QT prolongation. * In the opinion of the Investigator, has any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the trial results; these conditions include, but are not limited to: 1. Ongoing or active infection requiring antibiotic/antiviral/antifungal therapy 2. Concurrent congestive heart failure (New York Heart Association Functional Classification Class III or IV) 3. Concurrent unstable angina 4. Concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation) 5. Acute coronary syndrome within the previous 6 months 6. Significant pulmonary disease (shortness of breath at rest or on mild exertion) for example due concurrent severe obstructive pulmonary disease. * Has a cognitive, psychological or psychosocial impediment that would impair the ability of the patient to receive therapy according to the protocol or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures. * Is pregnant or breastfeeding

exclude: false

characteristic

code: Accepts Healthy Volunteers

value: false

exclude: false

characteristic

code: Age

value: 18-? year

exclude: false

characteristic

code: Age Group

value: Group: type = person; actual = false

exclude: false

Request:

PUT Group/mii-exa-mtb-study-cldn6-eligibility-criteria

Entry 111 - fullUrl = http://example.org/fhir/Group/mii-exa-mtb-study-cldn6-eligibility-criteria-age-groups

Resso}:

Language: de

type: Person

actual: false

characteristic

code: Age Group (Adult)

value: Adulthood (qualifier value)

exclude: false

characteristic

code: Age Group (Older Adult)

value: Old age (qualifier value)

exclude: false

Request:

PUT Group/mii-exa-mtb-study-cldn6-eligibility-criteria-age-groups

Entry 112 - fullUrl = http://example.org/fhir/Group/mii-exa-mtb-study-cldn6-comparison-group-0

Resso}:

Language: de

type: Person

actual: false

Characteristics

-CodeValue[x]Exclude
*Exposed toBiological: CLDN6 CAR-Tfalse

Request:

PUT Group/mii-exa-mtb-study-cldn6-comparison-group-0

Entry 113 - fullUrl = http://example.org/fhir/EvidenceVariable/mii-exa-mtb-study-cldn6-evidence-variable-0

Resso}:

Language: de

status: Active

UseContexts

-CodeValue[x]
*SNOMED CT: 362956003 (Procedure/intervention (navigational concept))Biological

Characteristics

-Definition[x]
*Group: type = person; actual = false; quantity = 145

Request:

PUT EvidenceVariable/mii-exa-mtb-study-cldn6-evidence-variable-0

Entry 114 - fullUrl = http://example.org/fhir/Group/mii-exa-mtb-study-cldn6-comparison-group-1

Resso}:

Language: de

type: Person

actual: false

Characteristics

-CodeValue[x]Exclude
*Exposed toBiological: CLDN6 uRNA-LPX/CLDN6 modRNA-LPXfalse

Request:

PUT Group/mii-exa-mtb-study-cldn6-comparison-group-1

Entry 115 - fullUrl = http://example.org/fhir/EvidenceVariable/mii-exa-mtb-study-cldn6-evidence-variable-1

Resso}:

Language: de

status: Active

UseContexts

-CodeValue[x]
*SNOMED CT: 362956003 (Procedure/intervention (navigational concept))Biological

Characteristics

-Definition[x]
*Group: type = person; actual = false; quantity = 145

Request:

PUT EvidenceVariable/mii-exa-mtb-study-cldn6-evidence-variable-1

Entry 116 - fullUrl = http://example.org/fhir/Organization/mii-exa-mtb-study-sponsor-biontech

Resso}:

Language: de

type: Clinical Research Sponsor

name: BioNTech Cell & Gene Therapies GmbH

Request:

PUT Organization/mii-exa-mtb-study-sponsor-biontech

Entry 117 - fullUrl = http://example.org/fhir/PractitionerRole/mii-exa-mtb-study-investigator-biontech

Resso}:

Language: de

Profile: MII PR Studie Beteiligte Person

code: Study coordinator

Request:

PUT PractitionerRole/mii-exa-mtb-study-investigator-biontech

Entry 118 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-0

Resso}:

Language: de

name: Peter MacCallum Cancer Centre

address: Melbourne Victoria 3000 Australia

Positions

-LongitudeLatitude
*144.96332-37.814

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-0

Entry 119 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-1

Resso}:

Language: de

name: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

address: Berlin 12200 Germany

Positions

-LongitudeLatitude
*13.4105352.52437

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-1

Entry 120 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-2

Resso}:

Language: de

name: Universitätsklinikum Erlangen - Hämatologie & Intrinsische Onkologie - Medizinische Klinik 5

address: Erlangen 91054 Germany

Positions

-LongitudeLatitude
*11.0078349.59099

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-2

Entry 121 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-3

Resso}:

Language: de

name: Universitätsklinikum Hamburg Eppendorf - II Medizinische Klinik und Poliklinik

address: Hamburg 20246 Germany

Positions

-LongitudeLatitude
*10.0153453.57532

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-3

Entry 122 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-4

Resso}:

Language: de

name: Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation

address: Hannover 30625 Germany

Positions

-LongitudeLatitude
*9.7332252.37052

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-4

Entry 123 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-5

Resso}:

Language: de

name: Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

address: Heidelberg 69120 Germany

Positions

-LongitudeLatitude
*8.6907949.40768

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-5

Entry 124 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-6

Resso}:

Language: de

name: Universitätsklinikum Köln AÖR-Centrum für Integrierte Onkologie (CIO)-Studienzentrum der Klinik I für Innere Medizin (CTU Cologne)

address: Köln 50937 Germany

Positions

-LongitudeLatitude
*6.9550.93333

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-6

Entry 125 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-7

Resso}:

Language: de

name: Universitätsmedizin Mainz - III Medizinische Klinik und Poliklinik

address: Mainz 55131 Germany

Positions

-LongitudeLatitude
*8.279149.98419

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-7

Entry 126 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-8

Resso}:

Language: de

name: Universitätsklinikum Regensburg - Klinik und Poliklinik für Innere Medizin III

address: Regensburg 93053 Germany

Positions

-LongitudeLatitude
*12.1016149.01513

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-8

Entry 127 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-9

Resso}:

Language: de

name: He Nederlands Kanker Instituut (The Netherlands Cancer Institute) - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

address: Amsterdam 1066 Netherlands

Positions

-LongitudeLatitude
*4.8896952.37403

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-9

Entry 128 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-10

Resso}:

Language: de

name: Erasmus MC - Universitair Medisch Centrum - Medical oncology

address: Rotterdam 3015 Netherlands

Positions

-LongitudeLatitude
*4.4791751.9225

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-10

Entry 129 - fullUrl = http://example.org/fhir/Location/mii-exa-mtb-study-cldn6-location-11

Resso}:

Language: de

name: Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska Universitetssjukhuset

address: Stockholm 14186 Sweden

Positions

-LongitudeLatitude
*18.064959.33258

Request:

PUT Location/mii-exa-mtb-study-cldn6-location-11

Entry 130 - fullUrl = http://example.org/fhir/ResearchStudy/mii-exa-mtb-study-tedova

Resso}:

Language: de

Profile: MII PR MTB Studie version: 2027.0.0-ballot.1

identifier: MII_NS_MTB_NCT/04713514

status: Active

Request:

PUT ResearchStudy/mii-exa-mtb-study-tedova

Entry 131 - fullUrl = http://example.org/fhir/ServiceRequest/mii-exa-mtb-study-request-tedova

Resso}:

Language: de

Profile: MII PR MTB Studieneinschluss Anfrage version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Priorität: 2.2

status: Draft

intent: Proposal

category: Clinical trial (procedure)

code: Referral to clinical trial (procedure)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

supportingInfo: ResearchStudy: identifier = https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct#MII_NS_MTB_NCT#04713514; status = active

Request:

PUT ServiceRequest/mii-exa-mtb-study-request-tedova

Entry 132 - fullUrl = http://example.org/fhir/ResearchStudy/mii-exa-mtb-study-ccne1

Resso}:

Language: de

Profile: MII PR MTB Studie version: 2027.0.0-ballot.1

status: Active

Request:

PUT ResearchStudy/mii-exa-mtb-study-ccne1

Entry 133 - fullUrl = http://example.org/fhir/ServiceRequest/mii-exa-mtb-study-request-ccne1

Resso}:

Language: de

Profile: MII PR MTB Studieneinschluss Anfrage version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Priorität: 2.3

status: Draft

intent: Proposal

category: Clinical trial (procedure)

code: Referral to clinical trial (procedure)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

supportingInfo: ResearchStudy: status = active

Request:

PUT ServiceRequest/mii-exa-mtb-study-request-ccne1

Entry 134 - fullUrl = http://example.org/fhir/MedicationRequest/mii-exa-mtb-medication-request-mirvetuximab

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Systemische Therapie version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Priorität: 1

MII EX MTB Empfehlung Evidenzgraduierung: m1A

MII EX MTB Empfehlung Publikation: http://doi.org/10.1200/JCO.2022.40.16_suppl.5512

MII EX MTB Empfehlung Publikation: http://www.ncbi.nlm.nih.gov/pubmed/38055253

status: Completed

intent: Proposal

medication: MIRVETUXIMAB SORAVTANSINE

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

reasonReference: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

basedOn: CarePlan: status = active; intent = plan; category = prätherapeutische Tumorkonferenz (Festlegung der Therapiestrategie); created = 2023-03-28

Request:

PUT MedicationRequest/mii-exa-mtb-medication-request-mirvetuximab

Entry 135 - fullUrl = http://example.org/fhir/MedicationRequest/mii-exa-mtb-medication-request-trastuzumab-deruxtecan

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Systemische Therapie version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Priorität: 3

MII EX MTB Empfehlung Evidenzgraduierung: m1B

MII EX MTB Empfehlung Publikation: http://www.ncbi.nlm.nih.gov/pubmed/35665782

MII EX MTB Empfehlung Publikation: http://www.ncbi.nlm.nih.gov/pubmed/37870536

MII EX MTB Empfehlung Publikation: http://doi.org/10.1200/JCO.2023.41.17_suppl.LBA3000

status: Draft

intent: Proposal

medication: Trastuzumab deruxtecan

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

reasonReference: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

Request:

PUT MedicationRequest/mii-exa-mtb-medication-request-trastuzumab-deruxtecan

Entry 136 - fullUrl = http://example.org/fhir/MedicationRequest/mii-exa-mtb-medication-request-adavosertib

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Systemische Therapie version: 2027.0.0-ballot.1

status: Draft

intent: Option

medication: ADAVOSERTIB

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

reasonReference: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

Request:

PUT MedicationRequest/mii-exa-mtb-medication-request-adavosertib

Entry 137 - fullUrl = http://example.org/fhir/MedicationRequest/mii-exa-mtb-medication-request-carboplatin

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Systemische Therapie version: 2027.0.0-ballot.1

status: Draft

intent: Option

medication: Carboplatin

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

reasonReference: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

Request:

PUT MedicationRequest/mii-exa-mtb-medication-request-carboplatin

Entry 138 - fullUrl = http://example.org/fhir/RequestGroup/mii-exa-mtb-request-group-adavosertib-carboplatin

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Kombinationstherapie version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Priorität: 4

MII EX MTB Empfehlung Evidenzgraduierung: m1B

MII EX MTB Empfehlung Publikation: http://www.ncbi.nlm.nih.gov/pubmed/37236033

status: Draft

intent: Proposal

code: Chemotherapie + zielgerichtete Substanzen

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

Actions

-Resource
*MedicationRequest: status = draft; intent = option; medication[x] = Carboplatin; authoredOn = 2023-03-28

Request:

PUT RequestGroup/mii-exa-mtb-request-group-adavosertib-carboplatin

Entry 139 - fullUrl = http://example.org/fhir/MedicationRequest/mii-exa-mtb-medication-request-lunresertib

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Systemische Therapie version: 2027.0.0-ballot.1

status: Draft

intent: Option

medication: LUNRESERTIB

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

reasonReference: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

Request:

PUT MedicationRequest/mii-exa-mtb-medication-request-lunresertib

Entry 140 - fullUrl = http://example.org/fhir/MedicationRequest/mii-exa-mtb-medication-request-camonsertib

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Systemische Therapie version: 2027.0.0-ballot.1

status: Draft

intent: Option

medication: CAMONSERTIB

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

reasonReference: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

Request:

PUT MedicationRequest/mii-exa-mtb-medication-request-camonsertib

Entry 141 - fullUrl = http://example.org/fhir/RequestGroup/mii-exa-mtb-request-group-lunresertib-camonsertib

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Kombinationstherapie version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Priorität: 5

MII EX MTB Empfehlung Evidenzgraduierung: m1B

MII EX MTB Empfehlung Publikation: http://doi.org/10.1158/1535-7163.TARG-23-PR008

status: Draft

intent: Proposal

code: zielgerichtete Substanzen

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

Actions

-Resource
*MedicationRequest: status = draft; intent = option; medication[x] = CAMONSERTIB; authoredOn = 2023-03-28

Request:

PUT RequestGroup/mii-exa-mtb-request-group-lunresertib-camonsertib

Entry 142 - fullUrl = http://example.org/fhir/MedicationRequest/mii-exa-mtb-medication-request-cobimetinib

Resso}:

Language: de

Profile: MII PR MTB Therapieempfehlung Systemische Therapie version: 2027.0.0-ballot.1

MII EX MTB Empfehlung Priorität: 6

MII EX MTB Empfehlung Evidenzgraduierung: m3

MII EX MTB Empfehlung Publikation: http://www.ncbi.nlm.nih.gov/pubmed/31209687

status: Draft

intent: Option

medication: COBIMETINIB

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

authoredOn: 2023-03-28

reasonReference: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

Request:

PUT MedicationRequest/mii-exa-mtb-medication-request-cobimetinib

Entry 143 - fullUrl = http://example.org/fhir/CarePlan/mii-exa-mtb-kim-musterperson-therapieplan

Resso}:

Language: de

Profile: MII PR MTB Therapieplan version: 2027.0.0-ballot.1

status: Active

intent: Plan

category: prätherapeutische Tumorkonferenz (Festlegung der Therapiestrategie)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

created: 2023-03-28

addresses: Condition Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

supportingInfo: ClinicalImpression: status = completed; effective[x] = 2023-01-20 --> 2023-03-28

activity

outcomeReference: Procedure Chemotherapy

reference: MedicationRequest: extension = 1,m1A,http://doi.org#10.1200/JCO.2022.40.16_suppl.5512,http://www.ncbi.nlm.nih.gov/pubmed#38055253; status = completed; intent = proposal; medication[x] = MIRVETUXIMAB SORAVTANSINE; authoredOn = 2023-03-28

activity

reference: ServiceRequest Referral to clinical trial (procedure)

activity

reference: ServiceRequest Referral to clinical trial (procedure)

activity

reference: ServiceRequest Referral to clinical trial (procedure)

activity

reference: MedicationRequest: extension = 3,m1B,http://www.ncbi.nlm.nih.gov/pubmed#35665782,http://www.ncbi.nlm.nih.gov/pubmed#37870536,http://doi.org#10.1200/JCO.2023.41.17_suppl.LBA3000; status = draft; intent = proposal; medication[x] = Trastuzumab deruxtecan; authoredOn = 2023-03-28

activity

reference: RequestGroup Chemotherapie + zielgerichtete Substanzen

activity

reference: RequestGroup zielgerichtete Substanzen

activity

reference: MedicationRequest: extension = 6,m3,http://www.ncbi.nlm.nih.gov/pubmed#31209687; status = draft; intent = option; medication[x] = COBIMETINIB; authoredOn = 2023-03-28

activity

reference: ServiceRequest Genetic consultation (procedure)

activity

reference: ServiceRequest Refer for histology (procedure)

activity

reference: ServiceRequest Biopsy (procedure)

Request:

PUT CarePlan/mii-exa-mtb-kim-musterperson-therapieplan

Entry 144 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-tumorzellgehalt-aszites

Resso}:

Language: de

Profile: MII PR MTB Tumorzellgehalt version: 2027.0.0-ballot.1

status: Final

code: Cells with cytogenetic abnormality [#] in Blood or Tissue by Molecular genetics method

value: 0.028 % (Details: UCUM code% = '%')

method: Histologisch

Request:

PUT Observation/mii-exa-mtb-kim-tumorzellgehalt-aszites

Entry 145 - fullUrl = http://example.org/fhir/ServiceRequest/mii-exa-mtb-kim-humangenetische-beratung-aszites

Resso}:

Language: de

Profile: MII PR MTB Human-genetische Beratung Auftrag version: 2027.0.0-ballot.1

status: Completed

intent: Proposal

code: Genetic consultation (procedure)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

reasonCode: Zweittumor

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Request:

PUT ServiceRequest/mii-exa-mtb-kim-humangenetische-beratung-aszites

Entry 146 - fullUrl = http://example.org/fhir/ServiceRequest/mii-exa-mtb-kim-histologie-evaluation-aszites

Resso}:

Language: de

Profile: MII PR MTB Histologie-Evaluation Auftrag version: 2027.0.0-ballot.1

status: Draft

intent: Proposal

code: Refer for histology (procedure)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

reasonReference: Observation Cells with cytogenetic abnormality [#] in Blood or Tissue by Molecular genetics method

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Request:

PUT ServiceRequest/mii-exa-mtb-kim-histologie-evaluation-aszites

Entry 147 - fullUrl = http://example.org/fhir/ServiceRequest/mii-exa-mtb-kim-rebiopsie-aszites

Resso}:

Language: de

Profile: MII PR MTB Biopsie Auftrag version: 2027.0.0-ballot.1

status: Completed

intent: Proposal

code: Biopsy (procedure)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

reasonReference: Observation Cells with cytogenetic abnormality [#] in Blood or Tissue by Molecular genetics method

specimen: Specimen: accessionIdentifier = Z230201/23; type = Ascitic fluid specimen (specimen)

Request:

PUT ServiceRequest/mii-exa-mtb-kim-rebiopsie-aszites

Entry 148 - fullUrl = http://example.org/fhir/Condition/mii-exa-mtb-kim-diagnose

Resso}:

Language: de

Profile: MII PR MTB Diagnose Primärtumor version: 2027.0.0-ballot.1

Condition Asserted Date: 2021-06-10

clinicalStatus: Active

verificationStatus: Unconfirmed

category: Neoplastic disease

code: Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

bodySite: Ovar

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

recordedDate: 2021-06-10

stage

assessment: Observation Tumor stage

type: Stage at Diagnosis

stage

assessment: Observation Histologic grade of neoplasm (observable entity)

type: Histologic type of proliferative mass

Request:

PUT Condition/mii-exa-mtb-kim-diagnose

Entry 149 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-tumorausbreitung

Resso}:

Language: de

Profile: MII PR MTB Tumorausbreitung version: 2027.0.0-ballot.1

status: Final

category: Aware of diagnosis

code: Tumor stage

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2021-06-10

value: Local tumor spread

Request:

PUT Observation/mii-exa-mtb-kim-tumorausbreitung

Entry 150 - fullUrl = http://example.org/fhir/Observation/mii-exa-mtb-kim-oncotree

Resso}:

Language: de

Profile: MII PR MTB Oncotree Klassifikation version: 2027.0.0-ballot.1

status: Final

code: Histologic grade of neoplasm (observable entity)

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

effective: 2021-06-10

value: HGONEC

Request:

PUT Observation/mii-exa-mtb-kim-oncotree

Entry 151 - fullUrl = http://example.org/fhir/Condition/PatientKimMusterperson-PrimaryDiagnosis-2

Resso}:

Condition Asserted Date: 2021-06-10

clinicalStatus: Active

verificationStatus: Unconfirmed

category: Neoplastic disease

code: Bösartige Neubildung: Peritoneum, nicht näher bezeichnet

bodySite: Ovar

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

recordedDate: 2021-06-10

Request:

PUT Condition/PatientKimMusterperson-PrimaryDiagnosis-2

Entry 152 - fullUrl = http://example.org/fhir/Observation/mii-exa-onko-allgemeiner-leistungszustand-ecog

Resso}:

status: Final

code: ECOG performance status

subject: Kim Musterperson (no stated gender), DoB: 1956-03-14

value: Gehfähig, Selbstversorgung möglich, aber nicht arbeitsfähig; kann mehr als 50 % der Wachzeit aufstehen (50 - 60 % nach Karnofsky)

Request:

PUT Observation/mii-exa-onko-allgemeiner-leistungszustand-ecog

Entry 153 - fullUrl = http://example.org/fhir/Organization/MyHospital

Resso}:

Language: de

type: Healthcare Provider

name: Example General Hospital

address: 1234 Health St Medicity CareState 12345 DE

Request:

PUT Organization/MyHospital

Entry 154 - fullUrl = http://example.org/fhir/Organization/MyInsurer

Resso}:

Language: de

type: Insurance Company

name: Example Health Insurance Co.

address: 789 Insurance Blvd Policytown InsureState 98765 DE

Request:

PUT Organization/MyInsurer

Entry 155 - fullUrl = http://example.org/fhir/Coverage/MyCoverage

Resso}:

Language: de

status: Active

type: extended healthcare

beneficiary: Kim Musterperson (no stated gender), DoB: 1956-03-14

period: 2023-01-01 --> 2025-12-31

payor: Organization Example Health Insurance Co.

Request:

PUT Coverage/MyCoverage