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

Versiones (1)
  1. 10/11/2023 10/11/2023 - 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 novembro de 2023

DOI

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Licencia

Creative Commons BY 4.0
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CombiCaRe study

Inglés

Intervention

12 formularios  
  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
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Intervention

12 formularios
  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])
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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