English

POD 3

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
Discharge
Description

Discharge

Alias
UMLS CUI [1,1]
C0030685
Is this the discharge visit?
Description

discharge visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0030685
UMLS CUI [1,2]
C0545082
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
Vital Signs
Description

Vital Signs

Alias
UMLS CUI [1,1]
C0518766
Body temperature
Description

Body temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
°C
Pulse rate
Description

Pulse rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
bpm
Respiration rate
Description

Respiration rate

Data type

integer

Measurement units
  • breaths per minute
Alias
UMLS CUI [1,1]
C0231832
breaths per minute
Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
mmHg
Laboratory Parameters
Description

Laboratory Parameters

Alias
UMLS CUI [1,1]
C0587081
Leucocytes
Description

Leucocytes

Data type

float

Measurement units
  • /nl
Alias
UMLS CUI [1,1]
C0023508
/nl
Erythrocytes
Description

Erythrocytes

Data type

float

Measurement units
  • /pl
Alias
UMLS CUI [1,1]
C0014772
/pl
Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • g/dl
Alias
UMLS CUI [1,1]
C0518015
g/dl
Hematokrit
Description

Hematokrit

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0518014
%
MCV
Description

MCV

Data type

float

Measurement units
  • fl
Alias
UMLS CUI [1,1]
C0524587
fl
MCH
Description

MCH

Data type

float

Measurement units
  • pg
Alias
UMLS CUI [1,1]
C0369183
pg
MCHC
Description

MCHC

Data type

float

Measurement units
  • g/dl
Alias
UMLS CUI [1,1]
C0474535
g/dl
RDW
Description

RDW

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0427460
%
Thrombocytes
Description

Thrombocytes

Data type

float

Measurement units
  • /nl
Alias
UMLS CUI [1,1]
C0005821
/nl
AST
Description

AST

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1,1]
C0201899
U/l
ALT
Description

ALT

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1,1]
C0201836
U/l
AP
Description

AP

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1,1]
C0201850
U/l
GGT
Description

GGT

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1,1]
C0202035
U/l
Bilirubine
Description

Bilirubine

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1,1]
C1278039
mg/dl
Serum creatinine
Description

Serum creatinine

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1,1]
C0201976
mg/dl
BUN
Description

BUN

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1,1]
C0005845
mg/dl
Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1,1]
C0337443
mmol/l
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1,1]
C0302353
mmol/l
PT
Description

PT

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0033707
%
INR
Description

INR

Data type

float

Alias
UMLS CUI [1,1]
C0525032
PTT
Description

PTT

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1,1]
C0030605
sec
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
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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POD 3

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
Discharge
C0030685 (UMLS CUI [1,1])
discharge visit
Item
Is this the discharge visit?
boolean
C0030685 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
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
Vital Signs
C0518766 (UMLS CUI [1,1])
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1,1])
Pulse rate
Item
Pulse rate
integer
C0232117 (UMLS CUI [1,1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1,1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
Item Group
Laboratory Parameters
C0587081 (UMLS CUI [1,1])
Leucocytes
Item
Leucocytes
float
C0023508 (UMLS CUI [1,1])
Erythrocytes
Item
Erythrocytes
float
C0014772 (UMLS CUI [1,1])
Hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1,1])
Hematokrit
Item
Hematokrit
float
C0518014 (UMLS CUI [1,1])
MCV
Item
MCV
float
C0524587 (UMLS CUI [1,1])
MCH
Item
MCH
float
C0369183 (UMLS CUI [1,1])
MCHC
Item
MCHC
float
C0474535 (UMLS CUI [1,1])
RDW
Item
RDW
float
C0427460 (UMLS CUI [1,1])
Thrombocytes
Item
Thrombocytes
float
C0005821 (UMLS CUI [1,1])
AST
Item
AST
float
C0201899 (UMLS CUI [1,1])
ALT
Item
ALT
float
C0201836 (UMLS CUI [1,1])
AP
Item
AP
float
C0201850 (UMLS CUI [1,1])
GGT
Item
GGT
float
C0202035 (UMLS CUI [1,1])
Bilirubine
Item
Bilirubine
float
C1278039 (UMLS CUI [1,1])
Serum creatinine
Item
Serum creatinine
float
C0201976 (UMLS CUI [1,1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1,1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1,1])
Potassium
Item
Potassium
float
C0302353 (UMLS CUI [1,1])
PT
Item
PT
float
C0033707 (UMLS CUI [1,1])
INR
Item
INR
float
C0525032 (UMLS CUI [1,1])
PTT
Item
PTT
float
C0030605 (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
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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