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45880

Description

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.

Keywords

Versions (1)
  1. 11/10/23 11/10/23 - Nelly Zental
Copyright Holder

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

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November 10, 2023

DOI

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License

Creative Commons BY 4.0
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    CombiCaRe study

    English

    Intervention

    12 forms  
    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
    Description

    5-FU treatment

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

    Start 5-FU date

    Data type

    date

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

    Start 5-FU time

    Data type

    time

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

    Planned dose 5-FU

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C2826283
    mg
    Modification of planned 5-FU dose?
    Description

    Modification 5-FU dose

    Data type

    boolean

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

    Reason modification

    Data type

    text

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

    specify reason

    Data type

    text

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

    Dose administered

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C2348343
    mg
    End of 5-FU chemotherapy (date)
    Description

    End 5-FU date

    Data type

    date

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

    End 5-FU time

    Data type

    time

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

    Calcium folinate and Granisetron treatment

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

    Modification Calcium folinate

    Data type

    boolean

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

    Reason modification

    Data type

    text

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

    specify reason

    Data type

    text

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

    Modification Granisetron

    Data type

    boolean

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

    specify discrepancy

    Data type

    text

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

    Surgery

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

    Date of surgery

    Data type

    date

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

    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
    Description

    Result re-evaluation

    Data type

    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
    Description

    Exclusion of liver metastasis

    Data type

    boolean

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

    Exclusion of peritoneal carcinomatosis

    Data type

    boolean

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

    Exclusion of superior mesenteric / hepatic artery encasement

    Data type

    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)
    Description

    Tumor location (pancreas)

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

    uncinate process

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0227580
    head
    Description

    head

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0227579
    body
    Description

    body

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0227582
    tail
    Description

    tail

    Data type

    boolean

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

    Surgery Details

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

    Start

    Data type

    time

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

    End

    Data type

    time

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

    surgical intervention

    Data type

    text

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

    specify surgical intervention

    Data type

    text

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

    Additional resections

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

    Vascular resections

    Data type

    boolean

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

    Vascular (venous) resections and reconstructions

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

    portal venous resection

    Data type

    boolean

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

    VMS resection

    Data type

    boolean

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

    other

    Data type

    boolean

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

    specify vascular resections

    Data type

    text

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

    Additional resections

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

    Additional resections

    Data type

    boolean

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

    If yes, please specify additional resections

    Alias
    UMLS CUI [1,1]
    C1521902
    lymphadenectomy
    Description

    lymphadenectomy

    Data type

    boolean

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

    extrapancreatic resections

    Data type

    boolean

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

    other

    Data type

    boolean

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

    specify extrapancreatic resection

    Data type

    text

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

    specify other

    Data type

    text

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

    Blood loss and Transfusion

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

    Intraoperative blood loss

    Data type

    boolean

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

    specify blood loss

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C1521902
    ml
    Blood transfusion
    Description

    Blood transfusion

    Data type

    boolean

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

    Type of blood transfusion

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

    red blood cell concentrates

    Data type

    boolean

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

    Volume red blood cell concentrates

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C0086252
    UMLS CUI [1,2]
    C1264726
    ml
    fresh frozen plasma (FFP)
    Description

    fresh frozen plasma (FFP)

    Data type

    boolean

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

    Volume FFPs

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C1293883
    UMLS CUI [1,2]
    C1264726
    ml
    thrombocyte concentrates
    Description

    thrombocyte concentrates

    Data type

    boolean

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

    Volume thrombocyte concentrates

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C1293886
    UMLS CUI [1,2]
    C1264726
    ml
    Translational Studies
    Description

    Translational Studies

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

    Blood sample

    Data type

    boolean

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

    Bone marrow

    Data type

    boolean

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

    Tumor tissue

    Data type

    boolean

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

    Concomitant Medication

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

    changes in Concomitant Medication

    Data type

    boolean

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

    If yes, please fill out eForm 'Concomitant Medication'

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

    Adverse Events

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

    Adverse Events occurred

    Data type

    boolean

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

    If yes, please fill out eForm 'Adverse Events'

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

    Protocol violations

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

    protocol violations occurred

    Data type

    boolean

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

    If yes, please fill out eForm 'Protocol Violation'

    Alias
    UMLS CUI [1,1]
    C3273494
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    Intervention

    12 forms
    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
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    CL.10
    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])
    CL.10
    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])
    CL.11
    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])
    CL.12
    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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