ID

45880

Beschrijving

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.

Trefwoorden

Versies (1)
  1. 10-11-23 10-11-23 - Nelly Zental
Houder van rechten

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

Geüploaded op

10 november 2023

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

CombiCaRe study

Engels

POD 30

12 Formulieren  
  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
Beschrijving

Study termination

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

premature termination

Datatype

boolean

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

Date

Datatype

date

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

Reason end

Datatype

text

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

specify reason

Datatype

text

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

Cause of death

Datatype

text

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

specify death

Datatype

text

Alias
UMLS CUI [1,1]
C1521902
Discharge
Beschrijving

Discharge

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

discharge

Datatype

boolean

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

Date of discharge

Datatype

date

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

ICU stay

Datatype

boolean

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

ICU days

Datatype

integer

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

Date of visit

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

Date of visit

Datatype

date

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

Translational Studies

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

Blood sample

Datatype

boolean

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

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
Beschrijving

Pancreas-associated

Datatype

boolean

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

POPF

Datatype

text

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

intraabdominal fluid-collection or abscess

Datatype

boolean

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

delayed gastric emptying

Datatype

text

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

PPH

Datatype

text

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

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)
Beschrijving

Bile leakage

Datatype

text

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

biliodigestive anastomosis insufficiency

Datatype

boolean

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

Perioperative bleeding

Datatype

boolean

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

Gastrointestinal bleeding

Datatype

boolean

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

Postoperative ileus

Datatype

boolean

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

Postoperative sepsis

Datatype

boolean

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

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)
Beschrijving

Chemotherapy-related complications (since last visit)

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

Anemia (Hb < 8 g/dl)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002871
Thrombocytopenia
Beschrijving

Thrombocytopenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040034
Leukopenia
Beschrijving

Leukopenia

Datatype

boolean

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

Allergic reactions

Datatype

boolean

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

Serotonin syndrome

Datatype

boolean

Alias
UMLS CUI [1,1]
C0699828
Mucositis
Beschrijving

Mucositis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0333355
stomatitis
Beschrijving

stomatitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038362
cheilitis
Beschrijving

cheilitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007971
esophagitis
Beschrijving

esophagitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0014868
proctitis
Beschrijving

proctitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033246
Diarrhea
Beschrijving

Diarrhea

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011991
Nausea
Beschrijving

Nausea

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027497
Vomiting
Beschrijving

Vomiting

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042963
Alopecia
Beschrijving

Alopecia

Datatype

boolean

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

Hand-and-foot syndrome

Datatype

boolean

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

Central neurotoxicity

Datatype

boolean

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

Peripheral neuropathy

Datatype

boolean

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

Renal failure

Datatype

boolean

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

GFR decreased

Datatype

boolean

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

specify GFR

Datatype

float

Maateenheden
  • ml/min
Alias
UMLS CUI [1,1]
C1521902
ml/min
serum creatinine increased
Beschrijving

serum creatinine increased

Datatype

boolean

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

specify serum creatinine

Datatype

float

Maateenheden
  • mg/dl
Alias
UMLS CUI [1,1]
C1521902
mg/dl
BUN increased
Beschrijving

BUN increased

Datatype

boolean

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

specify BUN

Datatype

float

Maateenheden
  • mg/dl
Alias
UMLS CUI [1,1]
C1521902
mg/dl
urine production decreased
Beschrijving

urine production decreased

Datatype

boolean

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

specify urine production

Datatype

integer

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

Liver damage

Datatype

boolean

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

AST > 5 x ULN

Datatype

boolean

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

ALT > 5 x ULN

Datatype

boolean

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

AP > 5 x ULN

Datatype

boolean

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

GGT > 5 x ULN

Datatype

boolean

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

bilirubine > 1.5 x ULN

Datatype

boolean

Alias
UMLS CUI [1,1]
C0311468
Cardiotoxicity
Beschrijving

Cardiotoxicity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0876994
Bronchospasm
Beschrijving

Bronchospasm

Datatype

boolean

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

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
Beschrijving

Readmission to hosptial

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

Readmission

Datatype

boolean

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

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

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

Concomitant Medication

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

changes in Concomitant Medication

Datatype

boolean

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

If yes, please fill out eForm 'Concomitant Medication'

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

Adverse Events

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

Adverse Events occurred

Datatype

boolean

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

If yes, please fill out eForm 'Adverse Events'

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

Protocol violations

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

protocol violations occurred

Datatype

boolean

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

If yes, please fill out eForm 'Protocol Violation'

Alias
UMLS CUI [1,1]
C3273494
Terug naar het begin van de pagina

Similar models

POD 30

12 Formulieren
  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)
Datatype
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])
Terug naar het begin van de pagina 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial