ID

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.

Uploaded on

November 10, 2023

DOI

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License

Creative Commons BY 4.0
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CombiCaRe study

English

POD 60/Discontinuation

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
Study termination
Description

Study termination

Alias
UMLS CUI [1,1]
C4684792
Was the trial terminated premature for this patient?
Description

premature termination

Data type

boolean

Alias
UMLS CUI [1,1]
C4684792
Date of premature trial termination / last contact
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C4684792
Reason for premature end of study participation
Description

Reason end

Data type

text

Alias
UMLS CUI [1,1]
C1709849
If other reason, please specify
Description

specify reason

Data type

text

Alias
UMLS CUI [1,1]
C1521902
Cause of death
Description

Cause of death

Data type

text

Alias
UMLS CUI [1,1]
C0007465
If other cause of death, please specify
Description

specify death

Data type

text

Alias
UMLS CUI [1,1]
C1521902
Discharge
Description

Discharge

Alias
UMLS CUI [1,1]
C0030685
Has the patient been discharged?
Description

discharge

Data type

boolean

Alias
UMLS CUI [1,1]
C0030685
Date of discharge
Description

Date of discharge

Data type

date

Alias
UMLS CUI [1,1]
C2361123
Patient needed intensive care unit (ICU) stay?
Description

ICU stay

Data type

boolean

Alias
UMLS CUI [1,1]
C0583239
Number of days in ICU
Description

ICU days

Data type

integer

Alias
UMLS CUI [1,1]
C0023303
UMLS CUI [1,2]
C0021708
Date of visit
Description

Date of visit

Alias
UMLS CUI [1,1]
C1320303
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1,1]
C1320303
Translational Studies
Description

Translational Studies

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

Blood sample

Data type

boolean

Alias
UMLS CUI [1,1]
C5401001
Pancreas-associated postoperative morbidity (since last visit)
Description

Pancreas-associated postoperative morbidity (since last visit)

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C3872643
Pancreas-associated postoperative morbidity
Description

Pancreas-associated

Data type

boolean

Alias
UMLS CUI [1,1]
C0332281
UMLS CUI [1,2]
C0030274
1. postoperative pancreatic fistula (POPF) according to the ISGPS classification
Description

POPF

Data type

text

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C0030290
2. intraabdominal fluid-collection or abscess
Description

intraabdominal fluid-collection or abscess

Data type

boolean

Alias
UMLS CUI [1,1]
C4285843
UMLS CUI [2,1]
C0243001
3. delayed gastric emptying (DGE) according to the ISGPS definitions
Description

delayed gastric emptying

Data type

text

Alias
UMLS CUI [1,1]
C0740411
4. postpancreatectomy hemorrhage (PPH) according to the ISGPS definitions
Description

PPH

Data type

text

Alias
UMLS CUI [1,1]
C0030279
UMLS CUI [1,2]
C0919874
Other postoperative morbidities (since last visit)
Description

Other postoperative morbidities (since last visit)

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C3872643
Bile leakage as defined by the International Study Group of Liver Surgery (ISGLS)
Description

Bile leakage

Data type

text

Alias
UMLS CUI [1,1]
C0400997
Insufficiency of the biliodigestive anastomosis
Description

biliodigestive anastomosis insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0231179
UMLS CUI [1,2]
C0401006
Perioperative bleeding
Description

Perioperative bleeding

Data type

boolean

Alias
UMLS CUI [1,1]
C4546042
Gastrointestinal bleeding
Description

Gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0017181
Postoperative ileus
Description

Postoperative ileus

Data type

boolean

Alias
UMLS CUI [1,1]
C0400877
Postoperative sepsis
Description

Postoperative sepsis

Data type

boolean

Alias
UMLS CUI [1,1]
C3698200
If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'
Description

If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C3273494
UMLS CUI [1,2]
C0877248
Chemotherapy-related complications (since last visit)
Description

Chemotherapy-related complications (since last visit)

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0742247
Anemia (Hb < 8 g/dl)
Description

Anemia (Hb < 8 g/dl)

Data type

boolean

Alias
UMLS CUI [1,1]
C0002871
Thrombocytopenia
Description

Thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0040034
Leukopenia
Description

Leukopenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0023530
Allergic reactions
Description

Allergic reactions

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
Serotonin syndrome
Description

Serotonin syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0699828
Mucositis
Description

Mucositis

Data type

boolean

Alias
UMLS CUI [1,1]
C0333355
stomatitis
Description

stomatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0038362
cheilitis
Description

cheilitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0007971
esophagitis
Description

esophagitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0014868
proctitis
Description

proctitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0033246
Diarrhea
Description

Diarrhea

Data type

boolean

Alias
UMLS CUI [1,1]
C0011991
Nausea
Description

Nausea

Data type

boolean

Alias
UMLS CUI [1,1]
C0027497
Vomiting
Description

Vomiting

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
Alopecia
Description

Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C0002170
Hand-and-foot syndrome
Description

Hand-and-foot syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0549410
Central neurotoxicity
Description

Central neurotoxicity

Data type

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C0205099
Peripheral neuropathy
Description

Peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
Renal failure
Description

Renal failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
GFR decreased
Description

GFR decreased

Data type

boolean

Alias
UMLS CUI [1,1]
C0853068
If GFR decreased, please specify
Description

specify GFR

Data type

float

Measurement units
  • ml/min
Alias
UMLS CUI [1,1]
C1521902
ml/min
serum creatinine increased
Description

serum creatinine increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0700225
If serum creatinine increased, please specify
Description

specify serum creatinine

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1,1]
C1521902
mg/dl
BUN increased
Description

BUN increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0151539
If BUN increased, please specify
Description

specify BUN

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1,1]
C1521902
mg/dl
urine production decreased
Description

urine production decreased

Data type

boolean

Alias
UMLS CUI [1,1]
C3887784
If urine production decreased, please specify
Description

specify urine production

Data type

integer

Measurement units
  • ml/24 Std.
Alias
UMLS CUI [1,1]
C1521902
ml/24 Std.
Liver damage
Description

Liver damage

Data type

boolean

Alias
UMLS CUI [1,1]
C0151763
AST > 5 x ULN
Description

AST > 5 x ULN

Data type

boolean

Alias
UMLS CUI [1,1]
C3888966
ALT > 5 x ULN
Description

ALT > 5 x ULN

Data type

boolean

Alias
UMLS CUI [1,1]
C3888967
AP > 5 x ULN
Description

AP > 5 x ULN

Data type

boolean

Alias
UMLS CUI [1,1]
C4315528
GGT > 5 x ULN
Description

GGT > 5 x ULN

Data type

boolean

Alias
UMLS CUI [1,1]
C0239702
bilirubine > 1.5 x ULN
Description

bilirubine > 1.5 x ULN

Data type

boolean

Alias
UMLS CUI [1,1]
C0311468
Cardiotoxicity
Description

Cardiotoxicity

Data type

boolean

Alias
UMLS CUI [1,1]
C0876994
Bronchospasm
Description

Bronchospasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0006266
If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'
Description

If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Readmission to hosptial
Description

Readmission to hosptial

Alias
UMLS CUI [1,1]
C0745042
Readmission to hospital since last visit
Description

Readmission

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C3872643
If yes, please enter readmission in eForm 'Readmission To Hospital'
Description

If yes, please enter readmission in eForm 'Readmission To Hospital'

Alias
UMLS CUI [1,1]
C0600290
UMLS CUI [1,2]
C3273494
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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Similar models

POD 60/Discontinuation

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
Study termination
C4684792 (UMLS CUI [1,1])
premature termination
Item
Was the trial terminated premature for this patient?
boolean
C4684792 (UMLS CUI [1,1])
Date
Item
Date of premature trial termination / last contact
date
C0805839 (UMLS CUI [1,1])
C0011008 (UMLS CUI [2,1])
C4684792 (UMLS CUI [2,2])
Item
Reason for premature end of study participation
text
C1709849 (UMLS CUI [1,1])
CL.17
Code List
Reason for premature end of study participation
CL Item
patient's withdrawal of informed consent (1)
C1707492 (UMLS CUI [1,1])
CL Item
lost to follow up (2)
C1302313 (UMLS CUI [1,1])
CL Item
death (3)
C1306577 (UMLS CUI [1,1])
CL Item
termination of the study by sponsor (4)
C1710224 (UMLS CUI [1,1])
CL Item
other (5)
C0205394 (UMLS CUI [1,1])
specify reason
Item
If other reason, please specify
text
C1521902 (UMLS CUI [1,1])
Item
Cause of death
text
C0007465 (UMLS CUI [1,1])
CL.18
Code List
Cause of death
CL Item
related to surgery (1)
C1704787 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
CL Item
related to tumor disease (2)
C2826292 (UMLS CUI [1,1])
CL Item
related to oncologic treatment other than surgery (3)
C1704787 (UMLS CUI [1,1])
C0597030 (UMLS CUI [1,2])
CL Item
other (4)
C0205394 (UMLS CUI [1,1])
CL Item
unknown (5)
C0439673 (UMLS CUI [1,1])
specify death
Item
If other cause of death, please specify
text
C1521902 (UMLS CUI [1,1])
Item Group
Discharge
C0030685 (UMLS CUI [1,1])
discharge
Item
Has the patient been discharged?
boolean
C0030685 (UMLS CUI [1,1])
Date of discharge
Item
Date of discharge
date
C2361123 (UMLS CUI [1,1])
ICU stay
Item
Patient needed intensive care unit (ICU) stay?
boolean
C0583239 (UMLS CUI [1,1])
ICU days
Item
Number of days in ICU
integer
C0023303 (UMLS CUI [1,1])
C0021708 (UMLS CUI [1,2])
Item Group
Date of visit
C1320303 (UMLS CUI [1,1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
Item Group
Translational Studies
C1519620 (UMLS CUI [1,1])
Blood sample
Item
Blood sample taken (peripheral vein)
boolean
C5401001 (UMLS CUI [1,1])
Item Group
Pancreas-associated postoperative morbidity (since last visit)
C0032790 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C3872643 (UMLS CUI [1,3])
Pancreas-associated
Item
Pancreas-associated postoperative morbidity
boolean
C0332281 (UMLS CUI [1,1])
C0030274 (UMLS CUI [1,2])
Item
1. postoperative pancreatic fistula (POPF) according to the ISGPS classification
text
C0032790 (UMLS CUI [1,1])
C0030290 (UMLS CUI [1,2])
CL.13
Code List
1. postoperative pancreatic fistula (POPF) according to the ISGPS classification
CL Item
No (1)
C1298908 (UMLS CUI [1,1])
CL Item
Biochemical Leak (2)
C0205474 (UMLS CUI [1,1])
C0332234 (UMLS CUI [1,2])
CL Item
Grade B POPF (3)
C0441806 (UMLS CUI [1,1])
CL Item
Grade C POPF (4)
C0441807 (UMLS CUI [1,1])
intraabdominal fluid-collection or abscess
Item
2. intraabdominal fluid-collection or abscess
boolean
C4285843 (UMLS CUI [1,1])
C0243001 (UMLS CUI [2,1])
Item
3. delayed gastric emptying (DGE) according to the ISGPS definitions
text
C0740411 (UMLS CUI [1,1])
CL.15
Code List
3. delayed gastric emptying (DGE) according to the ISGPS definitions
CL Item
no (1)
C1298908 (UMLS CUI [1,1])
CL Item
Grade A (2)
C0309195 (UMLS CUI [1,1])
CL Item
Grade B (3)
C0441806 (UMLS CUI [1,1])
CL Item
Grade C (4)
C0441807 (UMLS CUI [1,1])
Item
4. postpancreatectomy hemorrhage (PPH) according to the ISGPS definitions
text
C0030279 (UMLS CUI [1,1])
C0919874 (UMLS CUI [1,2])
CL.15
Code List
4. postpancreatectomy hemorrhage (PPH) according to the ISGPS definitions
CL Item
no (1)
C1298908 (UMLS CUI [1,1])
CL Item
Grade A (2)
C0309195 (UMLS CUI [1,1])
CL Item
Grade B (3)
C0441806 (UMLS CUI [1,1])
CL Item
Grade C (4)
C0441807 (UMLS CUI [1,1])
Item Group
Other postoperative morbidities (since last visit)
C0032790 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C3872643 (UMLS CUI [1,4])
Item
Bile leakage as defined by the International Study Group of Liver Surgery (ISGLS)
text
C0400997 (UMLS CUI [1,1])
CL.15
Code List
Bile leakage as defined by the International Study Group of Liver Surgery (ISGLS)
CL Item
no (1)
C1298908 (UMLS CUI [1,1])
CL Item
Grade A (2)
C0309195 (UMLS CUI [1,1])
CL Item
Grade B (3)
C0441806 (UMLS CUI [1,1])
CL Item
Grade C (4)
C0441807 (UMLS CUI [1,1])
biliodigestive anastomosis insufficiency
Item
Insufficiency of the biliodigestive anastomosis
boolean
C0231179 (UMLS CUI [1,1])
C0401006 (UMLS CUI [1,2])
Perioperative bleeding
Item
Perioperative bleeding
boolean
C4546042 (UMLS CUI [1,1])
Gastrointestinal bleeding
Item
Gastrointestinal bleeding
boolean
C0017181 (UMLS CUI [1,1])
Postoperative ileus
Item
Postoperative ileus
boolean
C0400877 (UMLS CUI [1,1])
Postoperative sepsis
Item
Postoperative sepsis
boolean
C3698200 (UMLS CUI [1,1])
Item Group
If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'
C3273494 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Chemotherapy-related complications (since last visit)
C3872643 (UMLS CUI [1,1])
C0742247 (UMLS CUI [1,2])
Anemia (Hb < 8 g/dl)
Item
Anemia (Hb < 8 g/dl)
boolean
C0002871 (UMLS CUI [1,1])
Thrombocytopenia
Item
Thrombocytopenia
boolean
C0040034 (UMLS CUI [1,1])
Leukopenia
Item
Leukopenia
boolean
C0023530 (UMLS CUI [1,1])
Allergic reactions
Item
Allergic reactions
boolean
C1527304 (UMLS CUI [1,1])
Serotonin syndrome
Item
Serotonin syndrome
boolean
C0699828 (UMLS CUI [1,1])
Mucositis
Item
Mucositis
boolean
C0333355 (UMLS CUI [1,1])
stomatitis
Item
stomatitis
boolean
C0038362 (UMLS CUI [1,1])
cheilitis
Item
cheilitis
boolean
C0007971 (UMLS CUI [1,1])
esophagitis
Item
esophagitis
boolean
C0014868 (UMLS CUI [1,1])
proctitis
Item
proctitis
boolean
C0033246 (UMLS CUI [1,1])
Diarrhea
Item
Diarrhea
boolean
C0011991 (UMLS CUI [1,1])
Nausea
Item
Nausea
boolean
C0027497 (UMLS CUI [1,1])
Vomiting
Item
Vomiting
boolean
C0042963 (UMLS CUI [1,1])
Alopecia
Item
Alopecia
boolean
C0002170 (UMLS CUI [1,1])
Hand-and-foot syndrome
Item
Hand-and-foot syndrome
boolean
C0549410 (UMLS CUI [1,1])
Central neurotoxicity
Item
Central neurotoxicity
boolean
C0235032 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])
Peripheral neuropathy
Item
Peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
Renal failure
Item
Renal failure
boolean
C0035078 (UMLS CUI [1,1])
GFR decreased
Item
GFR decreased
boolean
C0853068 (UMLS CUI [1,1])
specify GFR
Item
If GFR decreased, please specify
float
C1521902 (UMLS CUI [1,1])
serum creatinine increased
Item
serum creatinine increased
boolean
C0700225 (UMLS CUI [1,1])
specify serum creatinine
Item
If serum creatinine increased, please specify
float
C1521902 (UMLS CUI [1,1])
BUN increased
Item
BUN increased
boolean
C0151539 (UMLS CUI [1,1])
specify BUN
Item
If BUN increased, please specify
float
C1521902 (UMLS CUI [1,1])
urine production decreased
Item
urine production decreased
boolean
C3887784 (UMLS CUI [1,1])
specify urine production
Item
If urine production decreased, please specify
integer
C1521902 (UMLS CUI [1,1])
Liver damage
Item
Liver damage
boolean
C0151763 (UMLS CUI [1,1])
AST > 5 x ULN
Item
AST > 5 x ULN
boolean
C3888966 (UMLS CUI [1,1])
ALT > 5 x ULN
Item
ALT > 5 x ULN
boolean
C3888967 (UMLS CUI [1,1])
AP > 5 x ULN
Item
AP > 5 x ULN
boolean
C4315528 (UMLS CUI [1,1])
GGT > 5 x ULN
Item
GGT > 5 x ULN
boolean
C0239702 (UMLS CUI [1,1])
bilirubine > 1.5 x ULN
Item
bilirubine > 1.5 x ULN
boolean
C0311468 (UMLS CUI [1,1])
Cardiotoxicity
Item
Cardiotoxicity
boolean
C0876994 (UMLS CUI [1,1])
Bronchospasm
Item
Bronchospasm
boolean
C0006266 (UMLS CUI [1,1])
Item Group
If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Readmission to hosptial
C0745042 (UMLS CUI [1,1])
Readmission
Item
Readmission to hospital since last visit
boolean
C0019993 (UMLS CUI [1,1])
C3872643 (UMLS CUI [1,2])
Item Group
If yes, please enter readmission in eForm 'Readmission To Hospital'
C0600290 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
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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