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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