Logical model for the PROTECT-CHILD bio_sample table.

Logical model for the PROTECT-CHILD clinical_event table. Each visit record captures either the start or end of a clinical event.

Logical model for the PROTECT-CHILD clinical_event_type table.

Logical model for the PROTECT-CHILD clinical_variable table. Includes weight, height, diuresis, and concomitant disease.

Logical model for the PROTECT-CHILD concomitant_medication table.

Logical model for the PROTECT-CHILD donor table.

Logical model for the PROTECT-CHILD imm_pat table. Phase field (Induction / Maintenance) maps to MedicationStatement.category.

Logical model for the PROTECT-CHILD immunological_data table. Covers blood group, Rh, HLA allele typing, DSA, Banff category, C4d, and ANCA.

Logical model for the PROTECT-CHILD immunosuppressant catalogue table.

Logical model for the PROTECT-CHILD instrumental_investigation table.

Logical model for the PROTECT-CHILD lab_result table.

Logical model for the PROTECT-CHILD lab_test catalogue table.

Logical model for the PROTECT-CHILD microbiology table. Covers viral serology, DNA quantification, culture results, and BKVAN evidence.

Logical model for the PROTECT-CHILD patient table.

Logical model for the PROTECT-CHILD pre_medication table.

Logical model for the PROTECT-CHILD transplant table.

Logical model for the PROTECT-CHILD visit table.

Logical model for the PROTECT-CHILD vital_sign table. Contains standard vitals and ABPM measurements.

Biological sample linked to a transplant visit, aligned with the DMv1.2 bio_sample table. Patient navigable via Specimen.subject. Visit linked via extension[visit_id]. Analysis intent (genomic_sample / epigenomic_sample) is represented as BioSampleAnalysisRequest (ServiceRequest) resources with specimen = Reference(BioSample). send_ingemm_date maps to the native Specimen.receivedTime.

A work order representing the intent to perform omics analysis (genomic or epigenomic) on a BioSample. One instance per analysis type per sample. Analysis intent (genomic_sample / epigenomic_sample) is carried here as ServiceRequest.code; Specimen.type remains free for specimen material type. specimen = Reference(BioSample).

A clinical event for a transplant patient, aligned with the DMv1.2 clinical_event table. Event phase (START/END) is represented via native Condition lifecycle. The diagnosis-type events dgf, episodes-aki-after-ltx, histologic-evidence-cni-toxicity and hypoxic-ischemic-event-pltx are ClinicalEvent types (Condition.code from ClinicalEventTypeVS). The coded value vascular_complication_type is in Condition.evidence.code. Non-diagnosis boolean flags (concomitant-medications, treatment-adherence) are ClinicalEventFlagObservation resources. Free-text fields are in Condition.note. Dialysis episodes, retransplantation, and transplant-list entry are linked ClinicalEventProcedure resources via Procedure.reasonReference.

Non-diagnosis boolean flag associated with a clinical event (DMv1.2 clinical_event table): concomitant-medications or treatment-adherence. Each instance represents one true flag; absence of an instance for a given code means the flag is false. Linked to the parent ClinicalEvent via Observation.focus. Diagnosis-type flags (dgf, episodes-aki-after-ltx, histologic-evidence-cni-toxicity, hypoxic-ischemic-event-pltx) are ClinicalEvent Conditions.

A procedure sub-event associated with a clinical event (DMv1.2 dialysis episodes, retransplantation, transplant-list entry). Linked to the parent ClinicalEvent Condition via Procedure.reasonReference.

Clinical variables recorded for a transplant patient at a visit, aligned with the DMv1.2 clinical_variable table. Captures weight, height, and diuresis. Concomitant disease(s) are ConcomitantDisease (Condition) resources. Vital signs (BP, HR, O2, temperature) are in the VitalSign profile.

A comorbid or concomitant disease recorded for a transplant patient at a visit (DMv1.2 clinical_variable.concomitant_disease). Represented as a Condition on the patient's problem list. One instance per concomitant disease.

Concomitant medication record for a transplant patient at a visit, aligned with the DMv1.2 concomitant_medication table.

Type of liver graft (complete vs partial) captured as an Observation. Only applicable for liver or combined transplants — invariant pc-donor-1 enforces this when tx_type extension is present.

Immunological data panel for a transplant patient at a given visit, aligned with the DMv1.2 immunological_data table. Covers ABO/Rh blood typing, HLA allele typing (IMGT/HLA notation), DSA, Banff category, C4d, ANCA, and related fields.

Conformance: Systems producing this resource SHALL populate identifier, status, category, code, subject, encounter, and at least one component. Systems consuming this resource SHALL be able to process all defined components.

Immunosuppressive drug catalogue entry. imm_id is carried as an identifier; the drug name maps to Medication.code.

Pharmacokinetic monitoring result (pre-dose trough level, 2 h post-dose level / C2, or AUC) for an immunosuppressant therapy record. Linked to the parent ImmPat MedicationStatement via Observation.partOf. Use Observation.subject to carry the patient directly for FHIR searchability.

Immunosuppressive treatment record for a transplant patient (induction or maintenance), aligned with the DMv1.2 imm_pat table. Covers both induction and maintenance phases via MedicationStatement.category. Patient is navigable via context (Visit) → Visit.subject. Pharmacokinetic monitoring values (pre_dose_level, csa_2h_post_dose_level, auc) are represented as linked ImmPatPKObservation resources via Observation.partOf.

Catalogue entry for an instrumental investigation test type, aligned with the instrumental_investigation table.

An intraoperative complication that occurred during a transplant procedure (DMv1.2 transplant.intraoperative_complications). Represented as a Condition (encounter-diagnosis) and linked from the Transplant Procedure via Procedure.complicationDetail. One instance per complication. Free-text 'other' complications (intraoperative_complications_other) are carried in Condition.note.

Individual laboratory result for a transplant recipient, aligned with the lab_result table.

Definition of a laboratory test (catalogue entry), aligned with the lab_test table. Systems SHALL use LOINC codes from LabTestNameVS as the primary code. Local codes from LabTestLocalCS SHALL only be used for calculated values without a single unambiguous LOINC code.

Microbiology panel for transplant recipients and/or donors. Component slices cover virology (EBV, CMV, Parvovirus B19, HSV, Adenovirus, VZV, BKV) plus organ-specific findings. The transplant type (extension[tx-type]) is required when organ-specific components are populated; invariants pc-micro-1 and pc-micro-2 enforce applicability. Infection diagnoses (EBV hepatitis, BKVAN) are separate MicrobiologyDiagnosis (Condition) resources.

An infection-related diagnosis identified through microbiology/histology in a transplant recipient (DMv1.2 microbiology.ebv_hepatitis_liver, evidence_bkvan). Represented as a Condition. EBV hepatitis applies to liver/combined transplants; BK virus-associated nephropathy (BKVAN) to kidney/combined.

Panel Observation for patient or donor age at transplant (age_years, age_months). Category is #survey to distinguish from laboratory results. One instance per patient or donor. Subject accepts PatientTransplant or Donor.

Instrumental investigation performed on a transplant patient, aligned with the pat_inst_inv table. All DM fields map to native Observation elements — no extensions.

Panel Observation for pre-transplant immunological scalar facts: maximum PRA, most recent PRA, and histological diagnosis date. Category is #laboratory. One instance per transplant recipient. ABO/Rh and HLA typing are in ImmunologicalData.

Primary disease that led to transplantation (diag_primary_disease, date_diag_primary_disease). A single profile for both liver and renal primary disease; the affected organ is given in Condition.bodySite. date_diag_primary_disease maps to Condition.onsetDateTime.

Pre-transplant medication record aligned with the pre_medication table.

A subsidiary pre-transplant medication record (rituximab desensitisation or antiviral prophylaxis) linked to its parent PreMedication via MedicationStatement.partOf. status #completed = given; status #not-taken = explicitly not given.

A PROTECT-CHILD participating transplant centre. center_no (1–4) is carried as identifier.value in the study-centre namespace. All PatientTransplant resources reference their centre via Patient.managingOrganization.

Procedure profile representing a transplant, aligned with DMv1.2 transplant table. The donor is linked via extension[donor_id]. The associated Visit is linked natively via Procedure.encounter. Intraoperative details are represented as a single TransplantDetails panel Observation linked via Observation.partOf.

A surgical anastomosis performed as part of a transplant procedure (DMv1.2 transplant.type_surgical_biliary_anastomosis, type_ureteral_graft_anastomosis, other_type_ureteral_graft_anastomosis). Modelled as a Procedure linked to the transplant via Procedure.partOf, matching the OMOP PROCEDURE_OCCURRENCE representation. Biliary anastomoses apply to liver/combined transplants; ureteral anastomoses to kidney/combined. Free-text 'other' ureteral anastomosis types are carried in Procedure.code.text.

Intraoperative and peri-operative details panel for a transplant, aligned with the DMv1.2 transplant table. Non-organ-specific detail fields are components of a single Observation linked to the Transplant Procedure via Observation.partOf. One instance per transplant. Organ-specific surgical fields are modelled separately: anastomoses as TransplantAnastomosis (Procedure) via Procedure.partOf, and intraoperative complications as IntraoperativeComplication (Condition) via Procedure.complicationDetail.

Transplant donor profile based on the FHIR Patient resource, aligned with the donor table.

Transplant recipient profile based on the FHIR Patient resource, aligned with the DMv1.2 patient table. Blood group, Rh, and HLA data are in ImmunologicalData. Age at transplant is in PatientDemographicsObservation; PRA and histological date are in PatientImmunologyObservation. Patient.birthDate SHOULD also be populated when known. Primary disease diagnoses are PatientPrimaryDiseaseDiagnosis (Condition).

Encounter profile representing a visit in the transplant follow-up schedule. All clinical resources back-reference this Visit via their native encounter/context element or a slim extension on the resource itself. No extensions are needed on Visit.

Vital signs panel for a transplant patient at a visit, aligned with the DMv1.2 vital_sign table. Captures standard vitals plus ABPM (24-hour ambulatory blood pressure) metrics.

Reference to the donor associated with this transplant.

Records the transplant type (liver / kidney / combined) on resources that carry organ-specific data fields, enabling organ-specific FHIRPath invariants within a single resource.

visit_id – reference to the Visit during which this sample was collected.

ABO blood groups for transplant recipients and donors.

Banff classification category for allograft rejection assessment.

Types of surgical biliary anastomosis (DMv1.2 transplant.type_surgical_biliary_anastomosis). Liver and combined transplants only.

Allowed analysis type codes for BioSampleAnalysisRequest.code.

Codes for ClinicalEventFlagObservation.code — one per non-diagnosis boolean DM flag on the clinical_event table. Presence of an Observation with this code means the flag is true.

Allowed procedure types for ClinicalEventProcedure.

Allowed clinical event types in the PROTECT-CHILD study (DMv1.2).

Allowed concomitant disease codes in clinical_variable (DMv1.2).

HLA class of a donor-specific antibody (DSA): Class I or Class II.

Type of donor liver graft (donor.liver_type: Whole or Split).

Allowed UCUM dose units for immunosuppressant therapy records (DMv1.2 imm_pat.unit field).

ValueSet of immunosuppressive drug types.

Allowed PK observation types for ImmPatPKObservation.

Allowed phase values for MedicationStatement.category on ImmPat records.

ValueSet of instrumental investigation tests conducted.

Allowed intraoperative complications during transplantation.

Allowed UCUM units of measurement for lab result values (DMv1.2 unit field).

Allowed laboratory test names for the PROTECT-CHILD data model. LOINC codes are used as the primary standard; local codes from LabTestLocalCS are used only for calculated or composite measures without a single unambiguous LOINC equivalent.

Mean fluorescence intensity (MFI) strength category for donor-specific antibodies.

Infection-related diagnoses captured in the microbiology table: EBV hepatitis on the liver allograft, and histological evidence of BK virus-associated nephropathy (BKVAN).

Allowed results for the instrumental investigation test (Normal, Abnormal).

Allowed antihypertensive drugs for antihypertensive_treatment.

Rhesus (Rh) blood group factor: positive or negative.

Types of surgical anastomosis performed during transplantation — biliary (liver) or ureteral (kidney). Used as Procedure.code on TransplantAnastomosis; free-text 'other' anastomosis types are carried in Procedure.code.text.

Allowed transplant types.

Types of ureteral graft anastomosis (DMv1.2 transplant.type_ureteral_graft_anastomosis). Kidney and combined only.

Types of vascular complication occurring after solid-organ transplantation.

Allowed types of visits in the transplant follow-up schedule (DMv1.2).

ABO blood groups for transplant recipients and donors.

Banff working classification of kidney/liver allograft pathology categories (Solez et al.). See https://www.banfffoundation.org/ for the full classification.

Intended omics analysis type for a biological sample. Used as the ServiceRequest.code on BioSampleAnalysisRequest resources.

Coded non-diagnosis flags used in ClinicalEventFlagObservation.code to represent boolean DM fields on the clinical_event table. Presence of a flag Observation means the flag is true; absence means false.

Types of procedures linked to a ClinicalEvent via ClinicalEventProcedure.reasonReference. Used for dialysis episodes, retransplantation, and transplant-list entry (DMv1.2).

Types of clinical events in the PROTECT-CHILD study (DMv1.2), replacing outcome_type and post_event_type.

Concomitant disease codes used in the DMv1.2 clinical_variable table. Coded values are carried as ConcomitantDisease (Condition) resources via Condition.code.

Post-transplant donor-specific antibody HLA class.

Type of liver donation (whole vs split), per donor.liver_type.

Local component codes for immunological data panel slices. HLA allele positions use per-position codes (hla-a-1, hla-a-2, …) so that pattern-discriminator slicing can distinguish allele 1 from allele 2. Non-HLA codes cover DSA, Banff, C4d, ANCA, and related fields.

Local code for the PROTECT-CHILD composite immunological data panel, which covers ABO/Rh typing, HLA allele typing, DSA, Banff category, C4d, and ANCA.

Types of immunosuppressive drugs used in the transplant setting.

Types of pharmacokinetic monitoring observations for immunosuppressant therapy (DMv1.2 pre_dose_level, csa_2h_post_dose_level, auc).

Whether the immunosuppressant record is for induction or maintenance phase (DMv1.2). Used as MedicationStatement.category codes.

Types of instrumental investigation tests conducted (expanded for DMv1.2).

Intraoperative complications during transplantation (liver or kidney).

Local codes for laboratory tests that do not have a single unambiguous LOINC code in the PROTECT-CHILD context (e.g., calculated values or composite measures).

Mean fluorescence intensity category for DSA.

Local codes for microbiology panel Observation components.

Distinguishes maximum (historical) vs most recent PRA measurements. Used as component codes in PatientImmunologyObservation.

Local codes for the free-text components of a patient instrumental investigation (abnormality, other investigation).

Result of the instrumental investigation test conducted (Normal / Abnormal).

Local codes for PROTECT-CHILD patient observation panels and components.

Antihypertensive drugs used as pre-transplant medication.

Rh factor for transplant recipients and donors.

Codes for transplant-level details captured as Observation components.

Type of solid-organ transplant (liver, kidney, combined liver-kidney).

Types of biliary anastomosis used in liver transplantation.

Types of ureteral graft anastomosis used in transplantation (DMv1.2).

Types of vascular complications in transplant (DMv1.2).

Type of visit in the transplant follow-up schedule.

Local codes for vital-sign metrics with no published LOINC code: the vital-signs panel, systolic/diastolic blood pressure percentiles, daytime/night-time mean systolic and diastolic blood pressure, blood pressure load, and nocturnal dip percentages.

Single identifier namespace for PROTECT-CHILD record business identifiers (patient, donor, visit, transplant, and all per-visit clinical/lab/medication/specimen/event records). The resource type distinguishes the kind of record. Identifiers follow one convention: TOKEN-CENTRE-SEQUENCE, for example REC-1-0001 (patient, centre 1, sequence 1) or LBR-1-0006 (lab result); study-wide catalogue entries such as lab tests are not centre-qualified and use TOKEN-SEQUENCE, for example LBT-0001. Identifiers carry no clinical meaning.

Namespace for PROTECT-CHILD study centre identifiers (center_no = 1–4).

12-month post-transplant follow-up visit for recipient REC-1-0001. The vital-sign panel and the creatinine result recorded at the 1-month visit repeat here — the shape follow-up data takes across the study timeline.

6-month post-transplant follow-up visit. The concomitant medication in progress since January and the abdominal imaging performed for the follow-up are recorded against this visit.

Example biological sample aligned with DMv1.2. genomic_sample=true, epigenomic_sample=false.

Non-diagnosis boolean flag associated with the clinical event: treatment adherence was confirmed. The presence of this Observation means the flag is true; it links to its parent ClinicalEvent via Observation.focus.

Hemodialysis episode linked to a clinical event via reasonReference.

Retransplantation event linked to the graft-failure clinical event. retransplantation=true is implicit from the existence of this resource.

Date patient was listed for retransplantation, linked to the triggering clinical event.

Example clinical event recording the start of a liver rejection episode at an unscheduled clinical-event visit.

Acute kidney injury in the first week after liver transplantation, requiring temporary renal replacement therapy. Recorded against the transplant admission.

Example clinical variables for a transplant patient at a 1-month follow-up visit (DMv1.2).

Example concomitant disease (hypertension) recorded for a transplant patient at a follow-up visit (DMv1.2).

Example ongoing concomitant antihypertensive medication (DMv1.2).

Tacrolimus trough level (C0) linked to the maintenance ImmPat record via partOf.

Tacrolimus reduced from 0.1 to 0.06 mg/kg after EBV reactivation — the first-line response, and what leaves the graft exposed to the rejection two months later.

Methylprednisolone pulse, 10 mg/kg/day × 3 days, for the November rejection episode. Recorded as #maintenance — the DM has no rejection-treatment phase.

Biopsy work-up at the rejection episode: C4d, DSA class and MFI, antibody type, ANCA. banff_category is left empty on purpose — BanffCategoryCS is the KIDNEY classification; liver rejection uses the Banff RAI, which this model does not carry.

Pre-transplant immunological typing for recipient REC-1-0001: ABO/Rh group, the full HLA typing (A, B, C, DRB1, DP, DQB1) in IMGT/HLA notation, and the pre-transplant DSA screen. Recorded at the pre-transplant visit.

Methylprednisolone as an immunosuppressant catalogue entry.

Example induction immunosuppressant record (methylprednisolone) at time of transplant.

Example maintenance immunosuppressant record (tacrolimus) at 1-month visit. PK monitoring values are separate ImmPatPKObservation resources linked via Observation.partOf.

Basiliximab catalogue entry, used for induction in the kidney worked example.

Tacrolimus (FK506) catalogue entry, referenced by the maintenance ImmPat records in both worked examples.

Example instrumental investigation catalogue entry — Liver doppler ultrasound.

Example intraoperative complication (major bleeding) linked to the example transplant via Procedure.complicationDetail.

Example creatinine result for a transplant recipient.

Creatinine repeated at 12 months. Improved from 1.2, but 0.8 mg/dL is still above the paediatric reference range (~0.4–0.7), so it is flagged H — do not apply adult ranges.

ALT at the rejection visit. The rise from 86 to 210 U/L prompts the graft biopsy.

Alanine aminotransferase result for recipient REC-1-0001 at the 1-month follow-up visit.

Alanine aminotransferase result for recipient REC-1-0001 at the 12-month follow-up visit.

Albumin result for recipient REC-1-0001 at the 1-month follow-up visit.

Albumin result for recipient REC-1-0001 at the 12-month follow-up visit.

GGT at the rejection visit — the cholestatic component, with the bilirubin.

Total bilirubin at the rejection visit, raised with the transaminases and GGT.

Example lab test catalogue entry — Albumin, reported in g/dL.

Example microbiology diagnosis — EBV-associated hepatitis of the liver allograft.

Example microbiology panel for a liver transplant recipient.

Example liver doppler ultrasound result for a transplant recipient.

Liver biopsy taken when EBV DNA was detected. EBV hepatitis is a histological diagnosis — serology and viral load cannot separate it from rejection. Evidence for MicrobiologyDiagnosisExample1.

Pre-transplant antihypertensive field, recorded as #not-taken: none was needed, as children with cirrhosis are typically hypotensive. Her hypertension appears after transplant — see ConcomitantDiseaseExample1.

Rituximab, linked to the parent PreMedication via partOf. effectiveDateTime is the last dose (date_last_rituximab). Waiting-list desensitisation of a sensitised candidate (peak PRA 80%), not directed at a particular donor — the graft came from a deceased donor.

Example biliary anastomosis (duct-to-duct) performed as part of the example liver transplant, linked via Procedure.partOf.

Example transplant details panel for a liver transplant (DMv1.2).

Example vital signs panel for a transplant recipient at 1-month visit.

The same vital-signs panel repeated at the 12-month follow-up visit, showing how a panel recurs across the visit timeline.

Unscheduled visit prompted by the acute rejection episode. The rejection Condition, its treatment-adherence flag and the biopsy immunology panel are all recorded against this visit.

Age at donation for the transplant donor (PatientDemographicsObservation; subject = Reference(Donor)).

Partial (reduced-size) liver graft — a whole adult liver would be large-for-size for a 32.5 kg recipient.

ServiceRequest representing genomic_sample = true for BioSampleExample1.

Age at transplant for the recipient (PatientDemographicsObservation).

Primary liver disease diagnosis leading to transplantation.

PRA and histological diagnosis date for the recipient (PatientImmunologyObservation).

Primary renal disease diagnosis leading to transplantation.

Pre-transplant (baseline) episode for recipient REC-1-0001, running from the desensitisation work-up through the transplant admission and early post-operative period. The PRA and HLA typing, the rituximab desensitisation and pre-transplant medication, the transplant procedure with its anastomosis and intra-operative complication, and the induction immunosuppression all carry their back-reference to this visit. The data model has no separate visit type for a transplant admission, so the baseline visit covers it; the surgery keeps its own date in Procedure.performed.

Example transplant instance mapped from the DMv1.2 transplant table.

Example Patient instance conforming to Donor.

Example Patient instance conforming to DMv1.2 PatientTransplant.

Example visit. Clinical resources (ClinicalVariable, Microbiology, PreMedication, etc.) carry the back-reference to this Visit via their own .encounter / .context element or extension.

First scheduled follow-up visit after transplantation.

BK-virus infection with biopsy-proven nephropathy — the typed event the microbiology panel and histology support.

Histological evidence of BK-virus-associated nephropathy on the graft biopsy.

BK-virus surveillance in blood, urine and graft biopsy — the kidney-specific analytes of the microbiology panel, which a liver record does not carry.

Acute rejection on repeat biopsy, following the immunosuppression reduction that BKVAN required — a recognised route into rejection.

Basiliximab induction, 20 mg on the day of transplant and day 4 — the standard paediatric regimen.

Banff category, C4d and DSA from the repeat biopsy. A class II DSA alongside a C4d-negative Banff 4 picture — antibody present, but not antibody-mediated rejection, hence a steroid pulse.

Unscheduled visit at which BK-virus nephropathy was diagnosed on graft biopsy.

Acute rejection on a repeat biopsy, three months after BKVAN. The two are separated in time on purpose — BKVAN mimics rejection histologically and the treatments are opposed. See the worked-example page.

Serum creatinine at the termination visit.

Serum creatinine at the first scheduled follow-up, still above range as the graft recovers.

Creatinine risen from 1.6 to 2.4 mg/dL — what brings him in and prompts the graft biopsy.

Creatinine risen from 2.4 to 3.1 mg/dL — what triggers the repeat biopsy.

Delayed graft function in the first week after transplantation, requiring haemodialysis. This is the kidney-specific clinical event the liver example cannot carry.

Doppler ultrasound of the transplanted kidney at the 1-month visit.

Graft loss ten months after transplantation, after BKVAN and a rejection that did not fully respond. The study outcome — without it, a failed graft is indistinguishable from loss to follow-up.

Renal replacement therapy given for the delayed graft function episode, linked to it via reasonReference.

Intraoperative ischaemia of the graft kidney, referenced from the transplant Procedure via complicationDetail.

Living related donor for recipient REC-2-0001. Contrast with the deceased donor in the liver example.

Maintenance tacrolimus, started on the day of transplant alongside induction — a CNI does not wait for discharge.

Baseline work-up through the transplant admission and early post-operative period for recipient REC-2-0001.

Primary disease leading to transplantation: chronic kidney disease stage 5. The affected organ is carried in Condition.bodySite.

Paediatric kidney transplant recipient at the University of Padova (centre 2).

Age of recipient REC-2-0001 at transplantation.

Placement back on the transplant waiting list after graft failure (DMv1.2 clinical_event.date_entry_transplant_list).

Haemodialysis restarted on graft failure. Still running: the profile pins status to #completed, so ongoing therapy is shown by an open performedPeriod, not by status.

Methylprednisolone pulse, 10 mg/kg/day × 3 days, for the Banff 4 rejection. Recorded as #maintenance — the DM has no rejection-treatment phase.

Tacrolimus halved once BKVAN was proven — the only established treatment, and the step that exposes the graft to the rejection three months later.

Pre-dose (C0) tacrolimus level at the 1-month visit, linked to the maintenance record via Observation.partOf.

End-of-follow-up visit at which graft failure was recorded, dialysis restarted and the recipient relisted.

Living-donor kidney transplantation for recipient REC-2-0001. TransplantTypeCS codes one organ per transplant record.

Standard ureteroneocystostomy performed as part of the transplant, linked to it via Procedure.partOf. The liver example carries a biliary anastomosis in the same slot.

Blood pressure and heart rate at the first scheduled follow-up.

La Paz University Hospital, Madrid, Spain (center_no = 1).

University of Padova, Italy (center_no = 2).

Son Espases University Hospital, Palma, Spain (center_no = 3).

University Medical Centre Hamburg-Eppendorf, Germany (center_no = 4).

A paediatric kidney transplant recipient (REC-2-0001, Padova) from the pre-transplant work-up through the living-donor transplant, delayed graft function, follow-up, and a rejection episode with BK-virus nephropathy — assembled as one collection Bundle in which every internal reference resolves.

A single paediatric liver transplant recipient (REC-1-0001, La Paz) from enrolment through donor, transplant, intra-operative findings, follow-up visit, labs, biospecimen, immunosuppression, microbiology and post-transplant clinical events — assembled as one collection Bundle in which every internal reference resolves.