ID

45880

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2023-11-10 2023-11-10 - Nelly Zental
Rättsinnehavare

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

Uppladdad den

10 november 2023

DOI

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Licens

Creative Commons BY 4.0
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CombiCaRe study

Engelsk

POD 60/Discontinuation

12 Formulär  
  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
Beskrivning

Study termination

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

premature termination

Datatyp

boolean

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

Date

Datatyp

date

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

Reason end

Datatyp

text

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

specify reason

Datatyp

text

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

Cause of death

Datatyp

text

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

specify death

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
Discharge
Beskrivning

Discharge

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

discharge

Datatyp

boolean

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

Date of discharge

Datatyp

date

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

ICU stay

Datatyp

boolean

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

ICU days

Datatyp

integer

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

Date of visit

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

Date of visit

Datatyp

date

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

Translational Studies

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

Blood sample

Datatyp

boolean

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

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
Beskrivning

Pancreas-associated

Datatyp

boolean

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

POPF

Datatyp

text

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

intraabdominal fluid-collection or abscess

Datatyp

boolean

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

delayed gastric emptying

Datatyp

text

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

PPH

Datatyp

text

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

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)
Beskrivning

Bile leakage

Datatyp

text

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

biliodigestive anastomosis insufficiency

Datatyp

boolean

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

Perioperative bleeding

Datatyp

boolean

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

Gastrointestinal bleeding

Datatyp

boolean

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

Postoperative ileus

Datatyp

boolean

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

Postoperative sepsis

Datatyp

boolean

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

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)
Beskrivning

Chemotherapy-related complications (since last visit)

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

Anemia (Hb < 8 g/dl)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002871
Thrombocytopenia
Beskrivning

Thrombocytopenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040034
Leukopenia
Beskrivning

Leukopenia

Datatyp

boolean

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

Allergic reactions

Datatyp

boolean

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

Serotonin syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0699828
Mucositis
Beskrivning

Mucositis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0333355
stomatitis
Beskrivning

stomatitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038362
cheilitis
Beskrivning

cheilitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007971
esophagitis
Beskrivning

esophagitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0014868
proctitis
Beskrivning

proctitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033246
Diarrhea
Beskrivning

Diarrhea

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011991
Nausea
Beskrivning

Nausea

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027497
Vomiting
Beskrivning

Vomiting

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042963
Alopecia
Beskrivning

Alopecia

Datatyp

boolean

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

Hand-and-foot syndrome

Datatyp

boolean

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

Central neurotoxicity

Datatyp

boolean

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

Peripheral neuropathy

Datatyp

boolean

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

Renal failure

Datatyp

boolean

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

GFR decreased

Datatyp

boolean

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

specify GFR

Datatyp

float

Måttenheter
  • ml/min
Alias
UMLS CUI [1,1]
C1521902
ml/min
serum creatinine increased
Beskrivning

serum creatinine increased

Datatyp

boolean

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

specify serum creatinine

Datatyp

float

Måttenheter
  • mg/dl
Alias
UMLS CUI [1,1]
C1521902
mg/dl
BUN increased
Beskrivning

BUN increased

Datatyp

boolean

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

specify BUN

Datatyp

float

Måttenheter
  • mg/dl
Alias
UMLS CUI [1,1]
C1521902
mg/dl
urine production decreased
Beskrivning

urine production decreased

Datatyp

boolean

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

specify urine production

Datatyp

integer

Måttenheter
  • ml/24 Std.
Alias
UMLS CUI [1,1]
C1521902
ml/24 Std.
Liver damage
Beskrivning

Liver damage

Datatyp

boolean

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

AST > 5 x ULN

Datatyp

boolean

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

ALT > 5 x ULN

Datatyp

boolean

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

AP > 5 x ULN

Datatyp

boolean

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

GGT > 5 x ULN

Datatyp

boolean

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

bilirubine > 1.5 x ULN

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0311468
Cardiotoxicity
Beskrivning

Cardiotoxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0876994
Bronchospasm
Beskrivning

Bronchospasm

Datatyp

boolean

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

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
Beskrivning

Readmission to hosptial

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

Readmission

Datatyp

boolean

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

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

Alias
UMLS CUI [1,1]
C0600290
UMLS CUI [1,2]
C3273494
Concomitant Medication
Beskrivning

Concomitant Medication

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

changes in Concomitant Medication

Datatyp

boolean

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

If yes, please fill out eForm 'Concomitant Medication'

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

Adverse Events

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

Adverse Events occurred

Datatyp

boolean

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

If yes, please fill out eForm 'Adverse Events'

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

Protocol violations

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

protocol violations occurred

Datatyp

boolean

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

If yes, please fill out eForm 'Protocol Violation'

Alias
UMLS CUI [1,1]
C3273494
Tillbaka till toppen

Similar models

POD 60/Discontinuation

12 Formulär
  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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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