ID

45880

Beschreibung

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.

Stichworte

Versionen (1)
  1. 10.11.23 10.11.23 - Nelly Zental
Rechteinhaber

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

Hochgeladen am

10. November 2023

DOI

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Lizenz

Creative Commons BY 4.0
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CombiCaRe study

Englisch

POD 60/Discontinuation

12 Formulare  
  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
Beschreibung

Study termination

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

premature termination

Datentyp

boolean

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

Date

Datentyp

date

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

Reason end

Datentyp

text

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

specify reason

Datentyp

text

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

Cause of death

Datentyp

text

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

specify death

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
Discharge
Beschreibung

Discharge

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

discharge

Datentyp

boolean

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

Date of discharge

Datentyp

date

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

ICU stay

Datentyp

boolean

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

ICU days

Datentyp

integer

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

Date of visit

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

Date of visit

Datentyp

date

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

Translational Studies

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

Blood sample

Datentyp

boolean

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

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
Beschreibung

Pancreas-associated

Datentyp

boolean

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

POPF

Datentyp

text

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

intraabdominal fluid-collection or abscess

Datentyp

boolean

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

delayed gastric emptying

Datentyp

text

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

PPH

Datentyp

text

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

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)
Beschreibung

Bile leakage

Datentyp

text

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

biliodigestive anastomosis insufficiency

Datentyp

boolean

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

Perioperative bleeding

Datentyp

boolean

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

Gastrointestinal bleeding

Datentyp

boolean

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

Postoperative ileus

Datentyp

boolean

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

Postoperative sepsis

Datentyp

boolean

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

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)
Beschreibung

Chemotherapy-related complications (since last visit)

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

Anemia (Hb < 8 g/dl)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002871
Thrombocytopenia
Beschreibung

Thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040034
Leukopenia
Beschreibung

Leukopenia

Datentyp

boolean

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

Allergic reactions

Datentyp

boolean

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

Serotonin syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0699828
Mucositis
Beschreibung

Mucositis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0333355
stomatitis
Beschreibung

stomatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038362
cheilitis
Beschreibung

cheilitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007971
esophagitis
Beschreibung

esophagitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0014868
proctitis
Beschreibung

proctitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033246
Diarrhea
Beschreibung

Diarrhea

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011991
Nausea
Beschreibung

Nausea

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027497
Vomiting
Beschreibung

Vomiting

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042963
Alopecia
Beschreibung

Alopecia

Datentyp

boolean

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

Hand-and-foot syndrome

Datentyp

boolean

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

Central neurotoxicity

Datentyp

boolean

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

Peripheral neuropathy

Datentyp

boolean

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

Renal failure

Datentyp

boolean

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

GFR decreased

Datentyp

boolean

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

specify GFR

Datentyp

float

Maßeinheiten
  • ml/min
Alias
UMLS CUI [1,1]
C1521902
ml/min
serum creatinine increased
Beschreibung

serum creatinine increased

Datentyp

boolean

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

specify serum creatinine

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1,1]
C1521902
mg/dl
BUN increased
Beschreibung

BUN increased

Datentyp

boolean

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

specify BUN

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1,1]
C1521902
mg/dl
urine production decreased
Beschreibung

urine production decreased

Datentyp

boolean

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

specify urine production

Datentyp

integer

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

Liver damage

Datentyp

boolean

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

AST > 5 x ULN

Datentyp

boolean

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

ALT > 5 x ULN

Datentyp

boolean

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

AP > 5 x ULN

Datentyp

boolean

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

GGT > 5 x ULN

Datentyp

boolean

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

bilirubine > 1.5 x ULN

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0311468
Cardiotoxicity
Beschreibung

Cardiotoxicity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0876994
Bronchospasm
Beschreibung

Bronchospasm

Datentyp

boolean

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

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
Beschreibung

Readmission to hosptial

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

Readmission

Datentyp

boolean

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

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

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

Concomitant Medication

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

changes in Concomitant Medication

Datentyp

boolean

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

If yes, please fill out eForm 'Concomitant Medication'

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

Adverse Events

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

Adverse Events occurred

Datentyp

boolean

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

If yes, please fill out eForm 'Adverse Events'

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

Protocol violations

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

protocol violations occurred

Datentyp

boolean

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

If yes, please fill out eForm 'Protocol Violation'

Alias
UMLS CUI [1,1]
C3273494
Zum Seitenanfang zurückkehren

Ähnliche Modelle

POD 60/Discontinuation

12 Formulare
  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)
Datentyp
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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