Generated Narrative: ClinicalImpression mii-exa-mtb-kim-musterperson-behandlungsepisode Profile: MII PR MTB Behandlungsepisodeversion: null2026.0.0) 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 423740007 investigation code: Was consent given item: Observation Was consent given supportingInfo: Procedure Computertomographie [CT], nativ Observation Metastatic malignant neoplasm (disorder) Observation Recurrent Observation Ascites Observation Status post (contextual qualifier) (qualifier value) Procedure Computertomographie [CT], nativ Observation Status post (contextual qualifier) (qualifier value) Observation Ascites Observation Recurrent Observation Atypical Procedure Computertomographie [CT], nativ Observation Status post (contextual qualifier) (qualifier value) Observation Status post (contextual qualifier) (qualifier value) Observation Ascites Observation Recurrent Observation Recurrent Observation Mediastinal lymph node group Observation Mediastinal lymph node group Procedure Computertomographie [CT], nativ Procedure/PatientKimMusterperson-Procedure-4a Procedure/PatientKimMusterperson-Procedure-4b Procedure/PatientKimMusterperson-Procedure-4c Procedure/PatientKimMusterperson-Procedure-4d Observation Progressive Observation Entire peritoneal serous membrane of peritoneum Observation Carcinomatosis of peritoneum Observation True pelvis Procedure/PatientKimMusterperson-SystemicTherapy-1 Procedure/PatientKimMusterperson-SystemicTherapy-2 Procedure/PatientKimMusterperson-SystemicTherapy-3 Procedure 367336001 Procedure Computertomographie [CT], nativ Observation Ascites Observation True pelvis Observation Localized enlarged lymph nodes Observation Lesion Procedure 367336001 Procedure Computertomographie [CT], nativ Observation Ascites Observation Recurrent Procedure Computertomographie [CT], nativ Observation True pelvis Observation Status post (contextual qualifier) (qualifier value) Observation/PatientKimMusterperson-Observation-28 Observation Mediastinal lymph node group Observation Mediastinal lymph node group
Generated Narrative: Observation mii-exa-mtb-kim-musterperson-aufklaerung Profile: MII PR MTB Consentversion: null2026.0.0) status: Final code: Was consent given subject: Kim Musterperson (no stated gender), DoB: 1956-03-14 effective: 2023-01-02 value: Yes (qualifier value)
Generated Narrative: Patient PatientKimMusterperson Kim Musterperson (no stated gender), DoB: 1956-03-14
Generated Narrative: Observation MTBObservationCA125-1 status: Final category: Laboratory studies (set), Labor 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')
Cancer Ag 125 [Units/volume] in Body fluid
Generated Narrative: Observation MTBObservationCA125-2 status: Final category: Laboratory studies (set), Labor 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')
Generated Narrative: Observation MTBObservationCA125-3 status: Final category: Laboratory studies (set), Labor 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')
Generated Narrative: Observation MTBObservationCA125-4 status: Final category: Laboratory studies (set), Labor 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')
Generated Narrative: Observation MTBObservationCA125-5 status: Final category: Laboratory studies (set), Labor 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')
Generated Narrative: Observation MTBObservationCA125-6 status: Final category: Laboratory studies (set), Labor 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')
Generated Narrative: DiagnosticReport PatientKimMusterperson-MolecularPathologyReport-1 Profile: MII PR MTB Molecular Pathology Reportversion: null2026.0.0) Pathology synoptic report Subject Kim Musterperson (no stated gender), DoB: 1956-03-14 Report Details Code Value Flags HER2 Ag [Presence] in Tissue by Immune stain 2+ Final
Generated Narrative: Specimen PatientKimMusterperson-AscitesSpecimen-2 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
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-0a-Her2neu Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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 - Code Value[x] * Gene studied [ID] ERBB2
HER2 Ag [Presence] in Tissue by Immune stain
Observation using immunohistochemistry (observable entity)
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyInterpret-0a-Her2neu Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, A characterization of a given biomarker observation. code: HER2 [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 - Code Value[x] * Gene studied [ID] ERBB2
Human epidermal growth factor receptor 2 low
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-0b-Folat-Ra Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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 - Code Value[x] * Gene studied [ID] FOLR1
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-0c-Trop2 Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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 - Code Value[x] * Gene studied [ID] TACSTD2
Tumor-associated calcium signal transducer 2
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-1-CA125 Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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 - Code Value[x] * Gene studied [ID] TACSTD2
Cancer Ag 125 [Presence] in Tissue by Immune stain
Die Tumorzellen sind partiell positiv für CA125,...
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-2-Pax8 Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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)
PAX8 Ag [Presence] in Tissue by Immune stain
Tumorzellen durchgehend nukleär für Pax 8
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-3-WT1 Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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 - Code Value[x] * Gene studied [ID] WT1
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-4-ER Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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)
Cells.estrogen receptor/cells in Tissue by Immune stain
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-5-PR Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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)
Cells.progesterone receptor/cells in Tissue by Immune stain
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-6-p53 Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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)
P53 protein Ag [Presence] in Tissue by Immune stain
Kräftige nukleäre Überexpression von p53
Generated Narrative: Observation PatientKimMusterperson-MolecularPathologyObservation-7-p53 Profile: MII PR MTB Immunohistochemistryversion: null2026.0.0) status: Final category: Labor, 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)
Generated Narrative: Procedure PatientKimMusterperson-Procedure-1 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
Generated Narrative: Procedure PatientKimMusterperson-Procedure-2 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
Generated Narrative: Procedure PatientKimMusterperson-Procedure-3 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
Generated Narrative: Procedure PatientKimMusterperson-Procedure-4 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
Generated Narrative: Procedure PatientKimMusterperson-Procedure-5 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
Generated Narrative: Procedure PatientKimMusterperson-Procedure-6 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
Generated Narrative: Procedure PatientKimMusterperson-Procedure-7 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
Generated Narrative: Observation PatientKimMusterperson-Observation-1 partOf: Procedure Computertomographie [CT], nativ status: Final code: Metastatic malignant neoplasm (disorder) value: kein Hinweis auf thorakale Metastasierung
Metastatic malignant neoplasm (disorder)
No evidence of (contextual qualifier) (qualifier value)
kein Hinweis auf thorakale Metastasierung
Generated Narrative: Observation PatientKimMusterperson-Observation-2 partOf: Procedure Computertomographie [CT], nativ status: Final code: Recurrent value: kein Hinweis auf Lokalrezidiv
Generated Narrative: Observation PatientKimMusterperson-Observation-3 partOf: Procedure Computertomographie [CT], nativ status: Final code: Ascites value: kein Aszites
Generated Narrative: Observation PatientKimMusterperson-Observation-4 partOf: Procedure Computertomographie [CT], nativ status: Final code: Status post (contextual qualifier) (qualifier value) value: Flüssigkeitskollektion angrenzend DD postoperativ bodySite: Entire duodenum
Status post (contextual qualifier) (qualifier value)
Resection of segment of liver (procedure)
Flüssigkeitskollektion angrenzend DD postoperativ
Generated Narrative: Observation PatientKimMusterperson-Observation-5 partOf: Procedure Computertomographie [CT], nativ status: Final code: Status post (contextual qualifier) (qualifier value) value: konstante Flüssigkeitskollektion angrenzend bodySite: Entire duodenum
konstante Flüssigkeitskollektion angrenzend
Generated Narrative: Observation PatientKimMusterperson-Observation-6 partOf: Procedure Computertomographie [CT], nativ status: Final code: Ascites value: kein Aszites
Generated Narrative: Observation PatientKimMusterperson-Observation-7 partOf: Procedure Computertomographie [CT], nativ status: Final code: Recurrent value: kein Hinweis auf Lokalrezidiv
Generated Narrative: Observation PatientKimMusterperson-Observation-8 partOf: Procedure Computertomographie [CT], nativ status: Final code: im linken Oberlappen der Lunge diskrete milchglasartige Trübung value: kein Hinweis auf thorakale Filiae
im linken Oberlappen der Lunge diskrete milchglasartige Trübung
Generated Narrative: Observation PatientKimMusterperson-Observation-9 partOf: Procedure Computertomographie [CT], nativ status: Final code: Status post (contextual qualifier) (qualifier value) value: regrediente Flüssigkeitskollektion am Leberrand bodySite: Entire liver
regrediente Flüssigkeitskollektion am Leberrand
Generated Narrative: Observation PatientKimMusterperson-Observation-10 partOf: Procedure Computertomographie [CT], nativ status: Final code: Status post (contextual qualifier) (qualifier value) value: Darüberhinaus kein Hinweis auf Leberfilialisierung. bodySite: Entire liver
Metastatic malignant neoplasm to liver (disorder)
Darüberhinaus kein Hinweis auf Leberfilialisierung.
Generated Narrative: Observation PatientKimMusterperson-Observation-11 partOf: Procedure Computertomographie [CT], nativ status: Final code: Ascites value: kein Aszites
Generated Narrative: Observation PatientKimMusterperson-Observation-12 partOf: Procedure Computertomographie [CT], nativ status: Final code: Recurrent value: kein Hinweis auf Lokalrezidiv
Generated Narrative: Observation PatientKimMusterperson-Observation-13 partOf: Procedure Computertomographie [CT], nativ status: Final code: regrediente Milchglasinfiltrate im linken Oberlappen value: a.e. atypisch entzündlich
regrediente Milchglasinfiltrate im linken Oberlappen
Generated Narrative: Observation PatientKimMusterperson-Observation-14 partOf: Procedure Computertomographie [CT], nativ status: Final code: mediastinaler Lymphknoten value: vermehrter mediastinaler Lymphknotenbesatz ohne Kontrastmittelaufnahme
vermehrter mediastinaler Lymphknotenbesatz ohne Kontrastmittelaufnahme
Generated Narrative: Observation PatientKimMusterperson-Observation-15 partOf: Procedure Computertomographie [CT], nativ status: Final code: mediastinaler Lymphknoten value: ohne pathologische Vergrößerung
Generated Narrative: Observation PatientKimMusterperson-Observation-16 partOf: Procedure Computertomographie [CT], nativ status: Final code: Progredienter Aszites value: 700 ml (Details: UCUM codemL = 'mL')
Generated Narrative: Observation PatientKimMusterperson-Observation-17 partOf: Procedure Computertomographie [CT], nativ status: Final code: Peritonealblatt value: Peritonealblatt mit zunehmender, unregelmäßiger KM-Aufnahme
Entire peritoneal serous membrane of peritoneum
Peritonealblatt mit zunehmender, unregelmäßiger KM-Aufnahme
Generated Narrative: Observation PatientKimMusterperson-Observation-18 partOf: Procedure Computertomographie [CT], nativ status: Final code: Peritonealkarzinose value: Progress
Generated Narrative: Observation PatientKimMusterperson-Observation-19 partOf: Procedure Computertomographie [CT], nativ status: Final code: kleinen Becken value: Lokalrezidiv bei kontrastmittelaufnehmender Raumforderung
Lokalrezidiv bei kontrastmittelaufnehmender Raumforderung
Generated Narrative: Observation PatientKimMusterperson-Observation-20 partOf: Procedure Computertomographie [CT], nativ status: Final code: Aszites value: Regredient
Generated Narrative: Observation PatientKimMusterperson-Observation-21 partOf: Procedure Computertomographie [CT], nativ status: Final code: im kleinen Becken value: rückläufige KM-Aufnahme der lokalrezidivsuspekten Raumforderung
rückläufige KM-Aufnahme der lokalrezidivsuspekten Raumforderung
Generated Narrative: Observation PatientKimMusterperson-Observation-22 partOf: Procedure Computertomographie [CT], nativ status: Final code: zahlenmäßig vermehrten LK im Mediastinum value: noch flaue, aber insgesamt regrediente KM-Aufnhame
zahlenmäßig vermehrten LK im Mediastinum
noch flaue, aber insgesamt regrediente KM-Aufnhame
Generated Narrative: Observation PatientKimMusterperson-Observation-23 partOf: Procedure Computertomographie [CT], nativ status: Final code: Läsion value: keine neue
Generated Narrative: Observation PatientKimMusterperson-Observation-24 partOf: Procedure Computertomographie [CT], nativ status: Final code: Ascites value: kein Aszites
Generated Narrative: Observation PatientKimMusterperson-Observation-25 partOf: Procedure Computertomographie [CT], nativ status: Final code: Lokalrezidiv value: regredientes Lokalrezidiv ohne KM-Aufnahme im kleinen Becken
regredientes Lokalrezidiv ohne KM-Aufnahme im kleinen Becken
Generated Narrative: Observation PatientKimMusterperson-Observation-26 partOf: Procedure Computertomographie [CT], nativ status: Final code: kleinen Becken value: geringer Aszites
Generated Narrative: Observation PatientKimMusterperson-Observation-27 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
vormals KM-aufnehmendes Lokalrezidiv im kleinen Becken
aktuell metrisch nur noch schwer fassbar
Generated Narrative: Observation PatientKimMusterperson-Observation-29 partOf: Procedure Computertomographie [CT], nativ status: Final code: mediastinale Lymphknoten value: formal noch vermehrte
Generated Narrative: Observation PatientKimMusterperson-Observation-30 partOf: Procedure Computertomographie [CT], nativ status: Final code: mediastinale Lymphknoten value: nicht mehr KM-aufnehmende
Generated Narrative: ClinicalImpression MII-EXA-MTB-Follow-Up-ClinicalImpression-1 Profile: MII PR MTB Clinical Impresssionversion: null2026.0.0) 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: Procedure Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie Claim: status = active; type = institutional; use = claim; created = 2023-03-10; priority = Normal ClaimResponse: status = active; type = institutional; use = claim; created = 2023-05-01; outcome = complete
Generated Narrative: Procedure MII-EXA-MTB-Systemische-Therapie-1 Profile: MII PR MTB Systemische Therapieversion: null2026.0.0) 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
Zytostatische Chemotherapie, Immuntherapie und antiretrovirale Therapie
Generated Narrative: MedicationStatement MII-EXA-MTB-Systemische-Therapie-Medication-1 Profiles: MII PR MTB Systemtherapie Medication Statement, https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-systemische-therapie-medication-statement|2026.0.0 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
24.06.2023 Z1 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MII-EXA-MTB-Systemische-Therapie-Medication-2 Profiles: MII PR MTB Systemtherapie Medication Statement, https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-systemische-therapie-medication-statement|2026.0.0 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
16.07.2023 Z2 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MII-EXA-MTB-Systemische-Therapie-Medication-3 Profiles: MII PR MTB Systemtherapie Medication Statement, https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-systemische-therapie-medication-statement|2026.0.0 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
07.08.2023 Z3 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MII-EXA-MTB-Systemische-Therapie-Medication-4 Profiles: MII PR MTB Systemtherapie Medication Statement, https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-systemische-therapie-medication-statement|2026.0.0 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
29.08.2023 Z4 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MII-EXA-MTB-Systemische-Therapie-Medication-5 Profiles: MII PR MTB Systemtherapie Medication Statement, https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-systemische-therapie-medication-statement|2026.0.0 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
20.09.2023 Z2 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MII-EXA-MTB-Systemische-Therapie-Medication-6 Profiles: MII PR MTB Systemtherapie Medication Statement, https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-systemische-therapie-medication-statement|2026.0.0 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
12.10.2023 Z3 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: Observation MII-EXA-MTB-Response-Befund-1 Profile: MII PR MTB Response Befundversion: null2026.0.0) 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 - Code Value[x] * Presence of metastatic neoplasm in regional lymph node (observable entity) kein Lymphknotenbefall nachweisbar
Status of regression of tumor (observable entity)
Presence of metastatic neoplasm in regional lymph node (observable entity)
Generated Narrative: Observation MII-EXA-MTB-Response-Befund-2 Profile: MII PR MTB Response Befundversion: null2026.0.0) 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 - Code Value[x] * Presence of metastatic neoplasm in regional lymph node (observable entity) kein Lymphknotenbefall nachweisbar
Generated Narrative: Claim MII-EXA-MTB-Antrag-Kostenuebernahme-1 Profile: MII PR MTB Antrag Kostenuebernahmeversion: null2026.0.0) 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 - Sequence Provider Responsible * 1 Organization Example Health Insurance Co. true Insurances - Sequence Focal Coverage ClaimResponse * 1 true Coverage: status = active; type = extended healthcare; period = 2023-01-01 --> 2025-12-31 ClaimResponse: status = active; type = institutional; use = claim; created = 2023-05-01; outcome = complete
Generated Narrative: ClaimResponse MII-EXA-MTB-Antwort-Kostenuebernahme-1 Profile: MII PR MTB Anwort Kostenuebernahmeversion: null2026.0.0) 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
Generated Narrative: Specimen PatientKimMusterperson-Specimen-1 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] Quantity Method * 2023-01-02 20 mL (Details: UCUM codemL = 'mL') 178012008
Generated Narrative: Procedure MTBChemo1Procedure Profile: MII PR MTB Systemische Vortherapieversion: null2026.0.0) MII EX Onko Systemische Therapie Intention: kurativ status: Completed category: 277132007 code: 367336001 subject: Kim Musterperson (no stated gender), DoB: 1956-03-14 performed: 2023-01-04 --> 2023-05-24 outcome: Reguläres Ende mit Substanzwechsel
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement1 Profile: MII PR Medikation MedicationStatement partOf: Procedure 367336001 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
Z1 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement1-1 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-01-04 status: Completed medication: L01XA02 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 DoseAndRates - Dose[x] * 5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')
Z1 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement1-2 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-01-04 status: Completed medication: L01DB01 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 DoseAndRates - Dose[x] * 30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement2 Profile: MII PR Medikation MedicationStatement partOf: Procedure 367336001 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
Z2 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement2-1 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-02-01 status: Completed medication: L01XA02 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 DoseAndRates - Dose[x] * 5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')
Z2 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement2-2 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-02-01 status: Completed medication: L01DB01 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 DoseAndRates - Dose[x] * 30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement3 Profile: MII PR Medikation MedicationStatement partOf: Procedure 367336001 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
Z3 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement3-1 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-03-01 status: Completed medication: L01XA02 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 DoseAndRates - Dose[x] * 5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')
Z3 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement3-2 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-03-01 status: Completed medication: L01DB01 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 DoseAndRates - Dose[x] * 30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement4 Profile: MII PR Medikation MedicationStatement partOf: Procedure 367336001 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
Z4 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement4-1 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-03-29 status: Completed medication: L01XA02 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 DoseAndRates - Dose[x] * 5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')
Z4 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement4-2 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-03-29 status: Completed medication: L01DB01 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 DoseAndRates - Dose[x] * 30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement5 Profile: MII PR Medikation MedicationStatement partOf: Procedure 367336001 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
Z5 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement5-1 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-04-26 status: Completed medication: L01XA02 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 DoseAndRates - Dose[x] * 5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')
Z5 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement5-2 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-04-26 status: Completed medication: L01DB01 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 DoseAndRates - Dose[x] * 30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement6 Profile: MII PR Medikation MedicationStatement partOf: Procedure 367336001 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
Z6 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2, d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement6-1 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-05-24 status: Completed medication: L01XA02 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 DoseAndRates - Dose[x] * 5 AUC (Details: UCUM codemg.min/ml = 'mg.min/ml')
Z6 Carboplatin AUC5 d1, pegliposomales Doxorubicin 30 mg/m2 d1
Generated Narrative: MedicationStatement MTBChemo1MedicationStatement6-2 Profile: MII PR Onkologie Systemische Therapie Medikation partOf: Procedure 367336001 MedicationStatement: status = completed; medication[x] = ; effective[x] = 2023-05-24 status: Completed medication: L01DB01 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 DoseAndRates - Dose[x] * 30 mg/m2 (Details: UCUM codemg/m2 = 'mg/m2')
Generated Narrative: Procedure MTBChemo2Procedure Profile: MII PR MTB Systemische Vortherapieversion: null2026.0.0) 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: 277132007 code: 367336001 subject: Kim Musterperson (no stated gender), DoB: 1956-03-14 performed: 2023-06-24 --> 2023-10-12 outcome: Reguläres Ende
Generated Narrative: MedicationStatement MTBChemo2MedicationStatement1 Profile: MII PR Medikation MedicationStatement 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 367336001 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
Z1 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MTBChemo2MedicationStatement2 Profile: MII PR Medikation MedicationStatement 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 367336001 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
Z2 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MTBChemo2MedicationStatement3 Profile: MII PR Medikation MedicationStatement 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 367336001 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
Z3 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MTBChemo2MedicationStatement4 Profile: MII PR Medikation MedicationStatement 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 367336001 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
Z4 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MTBChemo2MedicationStatement5 Profile: MII PR Medikation MedicationStatement 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 367336001 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
Z5 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: MedicationStatement MTBChemo2MedicationStatement6 Profile: MII PR Medikation MedicationStatement 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 367336001 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 DoseAndRates - Dose[x] * 6 mg/kg KG (Details: UCUM codemg/kg{KG} = 'mg/kg{KG}')
Z6 Mirvetuximab soravtansine 6mg/kg KG, Wdh d22
Generated Narrative: DiagnosticReport mii-exa-mtb-kim-musterperson-ngs-bericht Profile: MII PR MTB NGS-Berichtversion: null2026.0.0) Genetic analysis report (Genetics) Subject Kim Musterperson (no stated gender), DoB: 1956-03-14 Reported 2023-03-28 00:00:00+0000 Report Details Code Value Flags Genetic variant assessment Present Final Genetic variant assessment Present Final Genetic variant assessment Present Final
Generated Narrative: Procedure mii-exa-mtb-kim-musterperson-genomic-study Profile: MII PR MTB Genomic Studyversion: null2026.0.0) Genomic Study Analysis Extension: Procedure: extension = Next-Generation (NGS)/Massively parallel sequencing (MPS),SNV,SNV,GRCh38; status = completed; category = Labor Genomic Study Analysis Extension: Procedure: status = completed; category = Labor Genomic Study Analysis Extension: Procedure: extension = Immunohistochemistry; status = completed; category = Labor status: Completed category: Labor subject: Kim Musterperson (no stated gender), DoB: 1956-03-14
Generated Narrative: Procedure mii-exa-mtb-kim-musterperson-genomic-study-analysis-1 Profile: MII PR MTB Genomic Study Analysisversion: null2026.0.0) 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: Labor subject: Kim Musterperson (no stated gender), DoB: 1956-03-14
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Generated Narrative: Procedure mii-exa-mtb-kim-musterperson-genomic-study-analysis-2 Profile: MII PR MTB Genomic Study Analysisversion: null2026.0.0) status: Completed category: Labor subject: Kim Musterperson (no stated gender), DoB: 1956-03-14
Generated Narrative: Procedure mii-exa-mtb-kim-musterperson-genomic-study-analysis-3 Profile: MII PR MTB Genomic Study Analysisversion: null2026.0.0) Genomic Study Analysis Method Type: Immunohistochemistry status: Completed category: Labor subject: Kim Musterperson (no stated gender), DoB: 1956-03-14
Generated Narrative: Observation mii-exa-mtb-kim-musterperson-EinfacheVariante-TP53 Profile: MII PR MTB Einfache Varianteversion: null2026.0.0) 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
Generated Narrative: Observation mii-exa-mtb-kim-musterperson-DiagnostischeImplikation-TP53 Profile: MII PR MTB Diagnostische Implikationversion: null2026.0.0) status: Final category: Laboratory, Genetik code: Diagnostic Implication subject: Kim Musterperson (no stated gender), DoB: 1956-03-14 derivedFrom: Observation Genetic variant assessment Components - Code Value[x] * Genetic variation clinical significance [Imp] Pathogenic
Generated Narrative: Observation mii-exa-mtb-kim-musterperson-EinfacheVariante-PIK3R1 Profile: MII PR MTB Einfache Varianteversion: null2026.0.0) 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: NM_181523.2:p.E160*
Generated Narrative: Observation mii-exa-mtb-kim-musterperson-TherapeutischeImplikation-PIK3R1 Profile: MII PR MTB Therapeutische Implikationversion: null2026.0.0) 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
Ausweislich praeklinischer Daten liegt ein Ansprechen auf MEK-Inhibition nahe (PMID: 31209687, EL m3).
Mitogen-aktivierte Proteinkinase (MEK)-Inhibitoren
Generated Narrative: Observation mii-exa-mtb-kim-musterperson-CNVariante-CCNE1 Profile: MII PR MTB Copy Number Variantversion: null2026.0.0) 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')
Generated Narrative: ServiceRequest mii-exa-mtb-study-request-cldn6 Profile: MII PR MTB Studieneinschluss Anfrageversion: null2026.0.0) 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
Generated Narrative: ResearchStudy mii-exa-mtb-study-cldn6 Profile: MII PR MTB Studieversion: null2026.0.0) 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
Part 1 - CLDN6 CAR-T: Dose escalation in lymphodepleted patients until the MTD and/or RP2D
Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX: Dose escalation until the MTD and/or RP2D
Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship
Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs
Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period
Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay
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
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
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
Generated Narrative: Group mii-exa-mtb-study-cldn6-eligibility-criteria 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
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
Generated Narrative: Group mii-exa-mtb-study-cldn6-eligibility-criteria-age-groups 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
Generated Narrative: Group mii-exa-mtb-study-cldn6-comparison-group-0 type: Person actual: false Characteristics - Code Value[x] Exclude * Exposed to Biological: CLDN6 CAR-T false
Generated Narrative: EvidenceVariable mii-exa-mtb-study-cldn6-evidence-variable-0 status: Active UseContexts - Code Value[x] * SNOMED CT: 362956003 (Procedure/intervention (navigational concept)) Biological Characteristics - Definition[x] * Group: type = person; actual = false; quantity = 145
Procedure/intervention (navigational concept)
Generated Narrative: Group mii-exa-mtb-study-cldn6-comparison-group-1 type: Person actual: false Characteristics - Code Value[x] Exclude * Exposed to Biological: CLDN6 uRNA-LPX/CLDN6 modRNA-LPX false
Biological: CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
Generated Narrative: EvidenceVariable mii-exa-mtb-study-cldn6-evidence-variable-1 status: Active UseContexts - Code Value[x] * SNOMED CT: 362956003 (Procedure/intervention (navigational concept)) Biological Characteristics - Definition[x] * Group: type = person; actual = false; quantity = 145
Generated Narrative: Organization mii-exa-mtb-study-sponsor-biontech type: Clinical Research Sponsor name: BioNTech Cell & Gene Therapies GmbH
Generated Narrative: PractitionerRole mii-exa-mtb-study-investigator-biontech Profile: MII PR Studie Beteiligte Person code: Study coordinator
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-0 name: Peter MacCallum Cancer Centre address: Melbourne Victoria 3000 Australia Positions - Longitude Latitude * 144.96332 -37.814
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-1 name: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin address: Berlin 12200 Germany Positions - Longitude Latitude * 13.41053 52.52437
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-2 name: Universitätsklinikum Erlangen - Hämatologie & Intrinsische Onkologie - Medizinische Klinik 5 address: Erlangen 91054 Germany Positions - Longitude Latitude * 11.00783 49.59099
Universitätsklinikum Erlangen - Hämatologie & Intrinsische Onkologie - Medizinische Klinik 5
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-3 name: Universitätsklinikum Hamburg Eppendorf - II Medizinische Klinik und Poliklinik address: Hamburg 20246 Germany Positions - Longitude Latitude * 10.01534 53.57532
Universitätsklinikum Hamburg Eppendorf - II Medizinische Klinik und Poliklinik
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-4 name: Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation address: Hannover 30625 Germany Positions - Longitude Latitude * 9.73322 52.37052
Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-5 name: Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg address: Heidelberg 69120 Germany Positions - Longitude Latitude * 8.69079 49.40768
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-6 name: Universitätsklinikum Köln AÖR-Centrum für Integrierte Onkologie (CIO)-Studienzentrum der Klinik I für Innere Medizin (CTU Cologne) address: Köln 50937 Germany Positions - Longitude Latitude * 6.95 50.93333
Universitätsklinikum Köln AÖR-Centrum für Integrierte Onkologie (CIO)-Studienzentrum der Klinik I für Innere Medizin (CTU Cologne)
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-7 name: Universitätsmedizin Mainz - III Medizinische Klinik und Poliklinik address: Mainz 55131 Germany Positions - Longitude Latitude * 8.2791 49.98419
Universitätsmedizin Mainz - III Medizinische Klinik und Poliklinik
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-8 name: Universitätsklinikum Regensburg - Klinik und Poliklinik für Innere Medizin III address: Regensburg 93053 Germany Positions - Longitude Latitude * 12.10161 49.01513
Universitätsklinikum Regensburg - Klinik und Poliklinik für Innere Medizin III
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-9 name: He Nederlands Kanker Instituut (The Netherlands Cancer Institute) - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL) address: Amsterdam 1066 Netherlands Positions - Longitude Latitude * 4.88969 52.37403
He Nederlands Kanker Instituut (The Netherlands Cancer Institute) - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-10 name: Erasmus MC - Universitair Medisch Centrum - Medical oncology address: Rotterdam 3015 Netherlands Positions - Longitude Latitude * 4.47917 51.9225
Erasmus MC - Universitair Medisch Centrum - Medical oncology
Generated Narrative: Location mii-exa-mtb-study-cldn6-location-11 name: Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska Universitetssjukhuset address: Stockholm 14186 Sweden Positions - Longitude Latitude * 18.0649 59.33258
Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska Universitetssjukhuset
Generated Narrative: ResearchStudy mii-exa-mtb-study-tedova Profile: MII PR MTB Studieversion: null2026.0.0) identifier: MII_NS_MTB_NCT/04713514 status: Active
Generated Narrative: ServiceRequest mii-exa-mtb-study-request-tedova Profile: MII PR MTB Studieneinschluss Anfrageversion: null2026.0.0) 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
Generated Narrative: ResearchStudy mii-exa-mtb-study-ccne1 Profile: MII PR MTB Studieversion: null2026.0.0) status: Active
Generated Narrative: ServiceRequest mii-exa-mtb-study-request-ccne1 Profile: MII PR MTB Studieneinschluss Anfrageversion: null2026.0.0) 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
Generated Narrative: MedicationRequest mii-exa-mtb-medication-request-mirvetuximab Profile: MII PR MTB Therapieempfehlung Systemische Therapieversion: null2026.0.0) 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
Andere monoklonale Antikörper und Antikörper-Wirkstoff-Konjugate
Generated Narrative: MedicationRequest mii-exa-mtb-medication-request-trastuzumab-deruxtecan Profile: MII PR MTB Therapieempfehlung Systemische Therapieversion: null2026.0.0) 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
Generated Narrative: MedicationRequest mii-exa-mtb-medication-request-adavosertib Profile: MII PR MTB Therapieempfehlung Systemische Therapieversion: null2026.0.0) 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
Generated Narrative: MedicationRequest mii-exa-mtb-medication-request-carboplatin Profile: MII PR MTB Therapieempfehlung Systemische Therapieversion: null2026.0.0) 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
Generated Narrative: RequestGroup mii-exa-mtb-request-group-adavosertib-carboplatin Profile: MII PR MTB Therapieempfehlung Kombinationstherapieversion: null2026.0.0) 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
Chemotherapie + zielgerichtete Substanzen
Generated Narrative: MedicationRequest mii-exa-mtb-medication-request-lunresertib Profile: MII PR MTB Therapieempfehlung Systemische Therapieversion: null2026.0.0) 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
Generated Narrative: MedicationRequest mii-exa-mtb-medication-request-camonsertib Profile: MII PR MTB Therapieempfehlung Systemische Therapieversion: null2026.0.0) 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
Generated Narrative: RequestGroup mii-exa-mtb-request-group-lunresertib-camonsertib Profile: MII PR MTB Therapieempfehlung Kombinationstherapieversion: null2026.0.0) 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
Generated Narrative: MedicationRequest mii-exa-mtb-medication-request-cobimetinib Profile: MII PR MTB Therapieempfehlung Systemische Therapieversion: null2026.0.0) 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
Generated Narrative: CarePlan mii-exa-mtb-kim-musterperson-therapieplan Profile: MII PR MTB Therapieplanversion: null2026.0.0) 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 367336001 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)
Generated Narrative: Observation mii-exa-mtb-kim-tumorzellgehalt-aszites Profile: MII PR MTB Tumorzellgehaltversion: null2026.0.0) status: Final code: Cells with cytogenetic abnormality [#] in Blood or Tissue by Molecular genetics method value: 0.028 % (Details: UCUM code% = '%') method: Histologisch
Cells with cytogenetic abnormality [#] in Blood or Tissue by Molecular genetics method
Generated Narrative: ServiceRequest mii-exa-mtb-kim-humangenetische-beratung-aszites Profile: MII PR MTB Human-genetische Beratung Auftragversion: null2026.0.0) 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)
Generated Narrative: ServiceRequest mii-exa-mtb-kim-histologie-evaluation-aszites Profile: MII PR MTB Histologie-Evaluation Auftragversion: null2026.0.0) 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)
Generated Narrative: ServiceRequest mii-exa-mtb-kim-rebiopsie-aszites Profile: MII PR MTB Biopsie Auftragversion: null2026.0.0) 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)
Generated Narrative: Condition mii-exa-mtb-kim-diagnose Profile: MII PR MTB Diagnose Primärtumorversion: null2026.0.0) Condition Asserted Date: 2021-06-10 clinicalStatus: Active verificationStatus: Unconfirmed 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
Bösartige Neubildung: Peritoneum, nicht näher bezeichnet
Generated Narrative: Observation mii-exa-mtb-kim-tumorausbreitung Profile: MII PR MTB Tumorausbreitungversion: null2026.0.0) status: Final category: Aware of diagnosis code: Tumor stage subject: Kim Musterperson (no stated gender), DoB: 1956-03-14 effective: 2021-06-10 value: 255127006
Generated Narrative: Observation mii-exa-mtb-kim-oncotree Profile: MII PR MTB Oncotree Klassifikationversion: null2026.0.0) 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
Histologic grade of neoplasm (observable entity)
Generated Narrative: Condition PatientKimMusterperson-PrimaryDiagnosis-2 Profile: MII PR Onkologie Diagnose Primärtumor Condition Asserted Date: 2021-06-10 clinicalStatus: Active verificationStatus: Unconfirmed code: Bösartige Neubildung: Peritoneum, nicht näher bezeichnet bodySite: Ovar subject: Kim Musterperson (no stated gender), DoB: 1956-03-14 recordedDate: 2021-06-10
Generated Narrative: Observation mii-exa-onko-allgemeiner-leistungszustand-ecog Profile: MII PR Onkologie Allgemeiner Leistungszustand ECOG status: Final code: 423740007 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)
Gehfähig, Selbstversorgung möglich, aber nicht arbeitsfähig; kann mehr als 50 % der Wachzeit aufstehen (50 - 60 % nach Karnofsky)
Generated Narrative: Organization MyHospital type: Healthcare Provider name: Example General Hospital address: 1234 Health St Medicity CareState 12345 DE
Generated Narrative: Organization MyInsurer type: Insurance Company name: Example Health Insurance Co. address: 789 Insurance Blvd Policytown InsureState 98765 DE
Generated Narrative: Coverage MyCoverage 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.