0 Evaluaciones

ID

45880

Descripción

CombiCaRe Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study. Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Palabras clave

  1. 10/11/23 10/11/23 - Nelly Zental
Titular de derechos de autor

Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Subido en

10 de noviembre de 2023

DOI

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Licencia

Creative Commons BY 4.0

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    CombiCaRe study

    Intervention

    1. StudyEvent: combicare trial
      1. Screening
      2. Intervention
      3. POD 3
      4. POD 7
      5. POD 14 / Discharge
      6. POD 30
      7. POD 60/Discontinuation
      8. Signature
    2. StudyEvent: Readmission To Hospital
      1. Readmission To Hospital
    3. StudyEvent: Adverse Events
      1. Adverse Events
    4. StudyEvent: Concomitant Medication
      1. Concomitant Medication
    5. StudyEvent: Protocol Violation
      1. Protocol violation
    5-FU treatment
    Descripción

    5-FU treatment

    Alias
    UMLS CUI [1,1]
    C0016360
    UMLS CUI [1,2]
    C1533734
    Start of 5-FU chemotherapy (date)
    Descripción

    Start 5-FU date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0016360
    UMLS CUI [1,3]
    C0392920
    Start of 5-FU chemotherapy (time)
    Descripción

    Start 5-FU time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0016360
    UMLS CUI [1,3]
    C0392920
    Planned dose of 5-FU chemotherapy
    Descripción

    Planned dose 5-FU

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C2826283
    mg
    Modification of planned 5-FU dose?
    Descripción

    Modification 5-FU dose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1707811
    Reason for 5-FU dose modification
    Descripción

    Reason modification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    If other, please specify
    Descripción

    specify reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1521902
    Dose administered
    Descripción

    Dose administered

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C2348343
    mg
    End of 5-FU chemotherapy (date)
    Descripción

    End 5-FU date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0016360
    UMLS CUI [1,3]
    C0392920
    End of 5-FU chemotherapy (time)
    Descripción

    End 5-FU time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0016360
    UMLS CUI [1,3]
    C0392920
    Calcium folinate and Granisetron treatment
    Descripción

    Calcium folinate and Granisetron treatment

    Alias
    UMLS CUI [1,1]
    C0061863
    UMLS CUI [2,1]
    C0023413
    Modification of planned Calcium folinate treatment?
    Descripción

    Modification Calcium folinate

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1299575
    UMLS CUI [1,2]
    C0023413
    Reason for Calcium folinate dose modification
    Descripción

    Reason modification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    If other, please specify
    Descripción

    specify reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1521902
    Modification of planned Granisetron treatment?
    Descripción

    Modification Granisetron

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1299575
    UMLS CUI [1,2]
    C0061863
    If yes, please specify discrepancy
    Descripción

    specify discrepancy

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    UMLS CUI [1,2]
    C3840684)
    Surgery
    Descripción

    Surgery

    Alias
    UMLS CUI [1,1]
    C0543467
    Date of surgery
    Descripción

    Date of surgery

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0543467
    Intraoperative re-evaluation of resectability
    Descripción

    Intraoperative re-evaluation of resectability

    Alias
    UMLS CUI [1,1]
    C0456904
    UMLS CUI [1,2]
    C0681840
    UMLS CUI [1,3]
    C5396338
    Result of intraoperative re-evaluation of resectability
    Descripción

    Result re-evaluation

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0456904
    UMLS CUI [1,3]
    C0681840
    UMLS CUI [1,4]
    C5396338
    Exclusion of liver metastasis
    Descripción

    Exclusion of liver metastasis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2828389
    UMLS CUI [1,2]
    C0494165
    Exclusion of peritoneal carcinomatosis
    Descripción

    Exclusion of peritoneal carcinomatosis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2828389
    UMLS CUI [1,2]
    C0346990
    Exclusion of superior mesenteric / hepatic artery encasement
    Descripción

    Exclusion of superior mesenteric / hepatic artery encasement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2828389
    UMLS CUI [1,2]
    C4524504
    UMLS CUI [1,3]
    C0019145
    UMLS CUI [1,4]
    C0162861
    Tumor location (pancreas)
    Descripción

    Tumor location (pancreas)

    Alias
    UMLS CUI [1,1]
    C2063875
    uncinate process
    Descripción

    uncinate process

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0227580
    head
    Descripción

    head

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0227579
    body
    Descripción

    body

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0227582
    tail
    Descripción

    tail

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0227590
    Surgery Details
    Descripción

    Surgery Details

    Alias
    UMLS CUI [1,1]
    C5204320
    Start skin incision (time)
    Descripción

    Start

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0191279
    UMLS CUI [1,2]
    C1301880
    End of surgery (time)
    Descripción

    End

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0543467
    Performed surgical intervention
    Descripción

    surgical intervention

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C4035998
    If other, please specify
    Descripción

    specify surgical intervention

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    Additional resections
    Descripción

    Additional resections

    Alias
    UMLS CUI [1,1]
    C1524062
    UMLS CUI [1,2]
    C0015252
    Vascular (venous) resections and reconstructions
    Descripción

    Vascular resections

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0189617
    Vascular (venous) resections and reconstructions
    Descripción

    Vascular (venous) resections and reconstructions

    Alias
    UMLS CUI [1,1]
    C0189617
    portal venous resection
    Descripción

    portal venous resection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0226727
    UMLS CUI [1,2]
    C00152526
    VMS resection
    Descripción

    VMS resection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0226742
    UMLS CUI [1,2]
    C0015252
    other
    Descripción

    other

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    If other vascular resection, please specify
    Descripción

    specify vascular resections

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    Additional resections
    Descripción

    Additional resections

    Alias
    UMLS CUI [1,1]
    C1524062
    UMLS CUI [1,2]
    C0015252
    Additional resections
    Descripción

    Additional resections

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1706712
    UMLS CUI [1,2]
    C0015252
    If yes, please specify additional resections
    Descripción

    If yes, please specify additional resections

    Alias
    UMLS CUI [1,1]
    C1521902
    lymphadenectomy
    Descripción

    lymphadenectomy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0024203
    extrapancreatic resections
    Descripción

    extrapancreatic resections

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0015252
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C0030274
    other
    Descripción

    other

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    If extrapancreatic resection, please specify
    Descripción

    specify extrapancreatic resection

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    If other, please specify
    Descripción

    specify other

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    Blood loss and Transfusion
    Descripción

    Blood loss and Transfusion

    Alias
    UMLS CUI [1,1]
    C3163616
    UMLS CUI [1,2]
    C0005841
    Intraoperative blood loss (as estimated from the anesthesia protocol)
    Descripción

    Intraoperative blood loss

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C5208110
    If yes, please specify
    Descripción

    specify blood loss

    Tipo de datos

    float

    Unidades de medida
    • ml
    Alias
    UMLS CUI [1,1]
    C1521902
    ml
    Blood transfusion
    Descripción

    Blood transfusion

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005841
    Type of blood transfusion
    Descripción

    Type of blood transfusion

    Alias
    UMLS CUI [1,1]
    C5420007
    red blood cell concentrates
    Descripción

    red blood cell concentrates

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0086252
    Volume of red blood cell concentrates
    Descripción

    Volume red blood cell concentrates

    Tipo de datos

    float

    Unidades de medida
    • ml
    Alias
    UMLS CUI [1,1]
    C0086252
    UMLS CUI [1,2]
    C1264726
    ml
    fresh frozen plasma (FFP)
    Descripción

    fresh frozen plasma (FFP)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1293883
    Volume of fresh frozen plasma (FFP)
    Descripción

    Volume FFPs

    Tipo de datos

    float

    Unidades de medida
    • ml
    Alias
    UMLS CUI [1,1]
    C1293883
    UMLS CUI [1,2]
    C1264726
    ml
    thrombocyte concentrates
    Descripción

    thrombocyte concentrates

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1293886
    Volume of thrombocyte concentrates
    Descripción

    Volume thrombocyte concentrates

    Tipo de datos

    float

    Unidades de medida
    • ml
    Alias
    UMLS CUI [1,1]
    C1293886
    UMLS CUI [1,2]
    C1264726
    ml
    Translational Studies
    Descripción

    Translational Studies

    Alias
    UMLS CUI [1,1]
    C1519620
    Blood sample taken (portal vein and peripheral vein)
    Descripción

    Blood sample

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C2324289
    UMLS CUI [1,3]
    C5401001
    Bone marrow sample taken
    Descripción

    Bone marrow

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005954
    Tumor tissue sample taken
    Descripción

    Tumor tissue

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358
    Concomitant Medication
    Descripción

    Concomitant Medication

    Alias
    UMLS CUI [1,1]
    C2347852
    Any changes in Concomitant Medication (since last visit)?
    Descripción

    changes in Concomitant Medication

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3872643
    UMLS CUI [1,2]
    C0392747
    If yes, please fill out eForm 'Concomitant Medication'
    Descripción

    If yes, please fill out eForm 'Concomitant Medication'

    Alias
    UMLS CUI [1,1]
    C3273494
    UMLS CUI [1,2]
    C2347852
    Adverse Events
    Descripción

    Adverse Events

    Alias
    UMLS CUI [1,1]
    C0877248
    Any Adverse Events occurred since last visit?
    Descripción

    Adverse Events occurred

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3872643
    If yes, please fill out eForm 'Adverse Events'
    Descripción

    If yes, please fill out eForm 'Adverse Events'

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C3273494
    Protocol violations
    Descripción

    Protocol violations

    Alias
    UMLS CUI [1,1]
    C1709750
    Any protocol violations occurred since last visit?
    Descripción

    protocol violations occurred

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3872643
    If yes, please fill out eForm 'Protocol Violation'
    Descripción

    If yes, please fill out eForm 'Protocol Violation'

    Alias
    UMLS CUI [1,1]
    C3273494

    Similar models

    Intervention

    1. StudyEvent: combicare trial
      1. Screening
      2. Intervention
      3. POD 3
      4. POD 7
      5. POD 14 / Discharge
      6. POD 30
      7. POD 60/Discontinuation
      8. Signature
    2. StudyEvent: Readmission To Hospital
      1. Readmission To Hospital
    3. StudyEvent: Adverse Events
      1. Adverse Events
    4. StudyEvent: Concomitant Medication
      1. Concomitant Medication
    5. StudyEvent: Protocol Violation
      1. Protocol violation
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    5-FU treatment
    C0016360 (UMLS CUI [1,1])
    C1533734 (UMLS CUI [1,2])
    Start 5-FU date
    Item
    Start of 5-FU chemotherapy (date)
    date
    C0808070 (UMLS CUI [1,1])
    C0016360 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [1,3])
    Start 5-FU time
    Item
    Start of 5-FU chemotherapy (time)
    time
    C1301880 (UMLS CUI [1,1])
    C0016360 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [1,3])
    Planned dose 5-FU
    Item
    Planned dose of 5-FU chemotherapy
    float
    C2826283 (UMLS CUI [1,1])
    Modification 5-FU dose
    Item
    Modification of planned 5-FU dose?
    boolean
    C1707811 (UMLS CUI [1,1])
    Item
    Reason for 5-FU dose modification
    text
    C0392360 (UMLS CUI [1,1])
    Code List
    Reason for 5-FU dose modification
    CL Item
    toxicity (1)
    C0013221 (UMLS CUI [1,1])
    CL Item
    allergy (2)
    C0013182 (UMLS CUI [1,1])
    CL Item
    other (3)
    C0205394 (UMLS CUI [1,1])
    specify reason
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Dose administered
    Item
    Dose administered
    float
    C2348343 (UMLS CUI [1,1])
    End 5-FU date
    Item
    End of 5-FU chemotherapy (date)
    date
    C0806020 (UMLS CUI [1,1])
    C0016360 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [1,3])
    End 5-FU time
    Item
    End of 5-FU chemotherapy (time)
    time
    C1522314 (UMLS CUI [1,1])
    C0016360 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [1,3])
    Item Group
    Calcium folinate and Granisetron treatment
    C0061863 (UMLS CUI [1,1])
    C0023413 (UMLS CUI [2,1])
    Modification Calcium folinate
    Item
    Modification of planned Calcium folinate treatment?
    boolean
    C1299575 (UMLS CUI [1,1])
    C0023413 (UMLS CUI [1,2])
    Item
    Reason for Calcium folinate dose modification
    text
    C0392360 (UMLS CUI [1,1])
    Code List
    Reason for Calcium folinate dose modification
    CL Item
    toxicity (1)
    C0013221 (UMLS CUI [1,1])
    CL Item
    allergy (2)
    C0013182 (UMLS CUI [1,1])
    CL Item
    other (3)
    C0205394 (UMLS CUI [1,1])
    specify reason
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Modification Granisetron
    Item
    Modification of planned Granisetron treatment?
    boolean
    C1299575 (UMLS CUI [1,1])
    C0061863 (UMLS CUI [1,2])
    specify discrepancy
    Item
    If yes, please specify discrepancy
    text
    C1521902 (UMLS CUI [1,1])
    C3840684) (UMLS CUI [1,2])
    Item Group
    Surgery
    C0543467 (UMLS CUI [1,1])
    Date of surgery
    Item
    Date of surgery
    date
    C0011008 (UMLS CUI [1,1])
    C0543467 (UMLS CUI [1,2])
    Item Group
    Intraoperative re-evaluation of resectability
    C0456904 (UMLS CUI [1,1])
    C0681840 (UMLS CUI [1,2])
    C5396338 (UMLS CUI [1,3])
    Item
    Result of intraoperative re-evaluation of resectability
    text
    C1274040 (UMLS CUI [1,1])
    C0456904 (UMLS CUI [1,2])
    C0681840 (UMLS CUI [1,3])
    C5396338 (UMLS CUI [1,4])
    Code List
    Result of intraoperative re-evaluation of resectability
    CL Item
    intraoperative eligibility (1)
    C0013893 (UMLS CUI [1,1])
    C0456904 (UMLS CUI [1,2])
    CL Item
    violation of intraoperative eligibility (2)
    C1709750 (UMLS CUI [1,1])
    C0456904 (UMLS CUI [1,2])
    C0013893 (UMLS CUI [1,3])
    Exclusion of liver metastasis
    Item
    Exclusion of liver metastasis
    boolean
    C2828389 (UMLS CUI [1,1])
    C0494165 (UMLS CUI [1,2])
    Exclusion of peritoneal carcinomatosis
    Item
    Exclusion of peritoneal carcinomatosis
    boolean
    C2828389 (UMLS CUI [1,1])
    C0346990 (UMLS CUI [1,2])
    Exclusion of superior mesenteric / hepatic artery encasement
    Item
    Exclusion of superior mesenteric / hepatic artery encasement
    boolean
    C2828389 (UMLS CUI [1,1])
    C4524504 (UMLS CUI [1,2])
    C0019145 (UMLS CUI [1,3])
    C0162861 (UMLS CUI [1,4])
    Item Group
    Tumor location (pancreas)
    C2063875 (UMLS CUI [1,1])
    uncinate process
    Item
    uncinate process
    boolean
    C0227580 (UMLS CUI [1,1])
    head
    Item
    head
    boolean
    C0227579 (UMLS CUI [1,1])
    body
    Item
    body
    boolean
    C0227582 (UMLS CUI [1,1])
    tail
    Item
    tail
    boolean
    C0227590 (UMLS CUI [1,1])
    Item Group
    Surgery Details
    C5204320 (UMLS CUI [1,1])
    Start
    Item
    Start skin incision (time)
    time
    C0191279 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    End
    Item
    End of surgery (time)
    time
    C1522314 (UMLS CUI [1,1])
    C0543467 (UMLS CUI [1,2])
    Item
    Performed surgical intervention
    text
    C4035998 (UMLS CUI [1,1])
    Code List
    Performed surgical intervention
    CL Item
    partial pancreaticoduodenectomy (1)
    C0728938 (UMLS CUI [1,1])
    C0085162 (UMLS CUI [1,2])
    CL Item
    total pancreaticoduodenectomy (2)
    C2945589 (UMLS CUI [1,1])
    CL Item
    pancreatic left resection (3)
    C0400472 (UMLS CUI [1,1])
    CL Item
    other (4)
    C0205394 (UMLS CUI [1,1])
    specify surgical intervention
    Item
    If other, please specify
    text
    C1521902 (UMLS CUI [1,1])
    Item Group
    Additional resections
    C1524062 (UMLS CUI [1,1])
    C0015252 (UMLS CUI [1,2])
    Vascular resections
    Item
    Vascular (venous) resections and reconstructions
    boolean
    C0189617 (UMLS CUI [1,1])
    Item Group
    Vascular (venous) resections and reconstructions
    C0189617 (UMLS CUI [1,1])
    portal venous resection
    Item
    portal venous resection
    boolean
    C0226727 (UMLS CUI [1,1])
    C00152526 (UMLS CUI [1,2])
    VMS resection
    Item
    VMS resection
    boolean
    C0226742 (UMLS CUI [1,1])
    C0015252 (UMLS CUI [1,2])
    other
    Item
    other
    boolean
    C0205394 (UMLS CUI [1,1])
    specify vascular resections
    Item
    If other vascular resection, please specify
    text
    C1521902 (UMLS CUI [1,1])
    Item Group
    Additional resections
    C1524062 (UMLS CUI [1,1])
    C0015252 (UMLS CUI [1,2])
    Additional resections
    Item
    Additional resections
    boolean
    C1706712 (UMLS CUI [1,1])
    C0015252 (UMLS CUI [1,2])
    Item Group
    If yes, please specify additional resections
    C1521902 (UMLS CUI [1,1])
    lymphadenectomy
    Item
    lymphadenectomy
    boolean
    C0024203 (UMLS CUI [1,1])
    extrapancreatic resections
    Item
    extrapancreatic resections
    boolean
    C0015252 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C0030274 (UMLS CUI [1,3])
    other
    Item
    other
    boolean
    C0205394 (UMLS CUI [1,1])
    specify extrapancreatic resection
    Item
    If extrapancreatic resection, please specify
    text
    C1521902 (UMLS CUI [1,1])
    specify other
    Item
    If other, please specify
    text
    C1521902 (UMLS CUI [1,1])
    Item Group
    Blood loss and Transfusion
    C3163616 (UMLS CUI [1,1])
    C0005841 (UMLS CUI [1,2])
    Intraoperative blood loss
    Item
    Intraoperative blood loss (as estimated from the anesthesia protocol)
    boolean
    C5208110 (UMLS CUI [1,1])
    specify blood loss
    Item
    If yes, please specify
    float
    C1521902 (UMLS CUI [1,1])
    Blood transfusion
    Item
    Blood transfusion
    boolean
    C0005841 (UMLS CUI [1,1])
    Item Group
    Type of blood transfusion
    C5420007 (UMLS CUI [1,1])
    red blood cell concentrates
    Item
    red blood cell concentrates
    boolean
    C0086252 (UMLS CUI [1,1])
    Volume red blood cell concentrates
    Item
    Volume of red blood cell concentrates
    float
    C0086252 (UMLS CUI [1,1])
    C1264726 (UMLS CUI [1,2])
    fresh frozen plasma (FFP)
    Item
    fresh frozen plasma (FFP)
    boolean
    C1293883 (UMLS CUI [1,1])
    Volume FFPs
    Item
    Volume of fresh frozen plasma (FFP)
    float
    C1293883 (UMLS CUI [1,1])
    C1264726 (UMLS CUI [1,2])
    thrombocyte concentrates
    Item
    thrombocyte concentrates
    boolean
    C1293886 (UMLS CUI [1,1])
    Volume thrombocyte concentrates
    Item
    Volume of thrombocyte concentrates
    float
    C1293886 (UMLS CUI [1,1])
    C1264726 (UMLS CUI [1,2])
    Item Group
    Translational Studies
    C1519620 (UMLS CUI [1,1])
    Blood sample
    Item
    Blood sample taken (portal vein and peripheral vein)
    boolean
    C1277698 (UMLS CUI [1,1])
    C2324289 (UMLS CUI [1,2])
    C5401001 (UMLS CUI [1,3])
    Bone marrow
    Item
    Bone marrow sample taken
    boolean
    C0005954 (UMLS CUI [1,1])
    Tumor tissue
    Item
    Tumor tissue sample taken
    boolean
    C0475358 (UMLS CUI [1,1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI [1,1])
    changes in Concomitant Medication
    Item
    Any changes in Concomitant Medication (since last visit)?
    boolean
    C3872643 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    Item Group
    If yes, please fill out eForm 'Concomitant Medication'
    C3273494 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item Group
    Adverse Events
    C0877248 (UMLS CUI [1,1])
    Adverse Events occurred
    Item
    Any Adverse Events occurred since last visit?
    boolean
    C3872643 (UMLS CUI [1,1])
    Item Group
    If yes, please fill out eForm 'Adverse Events'
    C0877248 (UMLS CUI [1,1])
    C3273494 (UMLS CUI [1,2])
    Item Group
    Protocol violations
    C1709750 (UMLS CUI [1,1])
    protocol violations occurred
    Item
    Any protocol violations occurred since last visit?
    boolean
    C3872643 (UMLS CUI [1,1])
    Item Group
    If yes, please fill out eForm 'Protocol Violation'
    C3273494 (UMLS CUI [1,1])

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