ID

13541

Descrição

Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Palavras-chave

Versões (1)
  1. 15/02/2016 15/02/2016 -
Transferido a

15 de fevereiro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0
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Visit 6 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv

Inglês

Case Report Form (HIPEC) Visit 6

1 Formulários  
Visit 6:Day 7 post-surgery
Descrição

Visit 6:Day 7 post-surgery

Patient ID
Descrição

Patient ID

Tipo de dados

integer

Alias
UMLS CUI [1]
C1269815
CRF number
Descrição

CRF number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0449788
Date of visit
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
Vital signs, concomitant medication and CTCAE
Descrição

Vital signs, concomitant medication and CTCAE

Heart rate count
Descrição

Heart rate

Tipo de dados

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure measurement
Descrição

Blood pressure

Tipo de dados

text

Unidades de medida
  • mm/Hg
Alias
UMLS CUI [1]
C0005823
mm/Hg
Body Temperature
Descrição

Body Temperature

Tipo de dados

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Has concomitant medication been subject to change? If `Yes` please fill in Concomitant medication form.
Descrição

Concomitant agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
Recording of CTCAE: Have any AE occurred since the last Visit? If `Yes` please fill in AE-Form
Descrição

CTCAE

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1516728
Laboratory results
Descrição

Laboratory results

Date of venous blood sampling
Descrição

First venipuncture of that day

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0190979
UMLS CUI [1,2]
C0011008
Time of laboratory procedure (according to laboratory sheet)
Descrição

Time of laboratory procedure

Tipo de dados

time

Alias
UMLS CUI [1]
C0022885
Creatinine measurement value
Descrição

Serologic tests Creatinine

Tipo de dados

integer

Unidades de medida
  • mg/dl
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201975
mg/dl
Is Creatinine value within normal range?
Descrição

Serologic tests Creatinine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201975
Are Creatinine measurement findings clinically significant? If `Yes`, please fill in AE- form.
Descrição

Serologic tests Creatinine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201975
Urea measurement value
Descrição

Serologic tests Urea measurement

Tipo de dados

integer

Unidades de medida
  • mg/dl
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0523961
mg/dl
Is Urea measurement value within normal range?
Descrição

Serologic tests Urea measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0523961
Are Urea measurement findings clinically significant? If `Yes`, please fill in AE-Form.
Descrição

Serologic tests Urea measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0523961
Bilirubin measurement value
Descrição

Serologic tests Bilirubin measurement

Tipo de dados

integer

Unidades de medida
  • mg/dl
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0344395
mg/dl
Is Bilirubin measurement value within normal range?
Descrição

Serologic tests Bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0344395
Are Bilirubin measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Serologic tests Bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0344395
GPT measurement value
Descrição

Serologic tests GPT measurement

Tipo de dados

integer

Unidades de medida
  • U/l
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201836
U/l
Is GPT value within normal range?
Descrição

Serologic tests GPT measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201836
Are GPT measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Serologic measurement GPT measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201836
GOT measurement value
Descrição

Serologic tests GOT measurement

Tipo de dados

integer

Unidades de medida
  • U/l
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201899
U/l
Is GOT value within normal range?
Descrição

Serologic tests GOT measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201899
Are GOT measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Serologic tests GOT measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201899
GGT measurement value
Descrição

Serologic tests GGT measurement

Tipo de dados

integer

Unidades de medida
  • U/l
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0202035
U/l
Is GGT measurement within normal range?
Descrição

Serologic tests GGT Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0202035
Are GGT measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Serologic tests GGT measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0202035
Albumin measurement value
Descrição

Serologic tests Albumin measurement

Tipo de dados

integer

Unidades de medida
  • g/l
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201838
g/l
Is Albumin measurement within normal range?
Descrição

Serologic tests Albumin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201838
Are Albumin measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Serologic tests Albumin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201838
Serum potassium measurement value
Descrição

Serologic tests serum potassium

Tipo de dados

integer

Unidades de medida
  • mmol/l
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0302353
mmol/l
Is serum potassium measurement value within normal range?
Descrição

Serologic tests serum potassium

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0302353
Are serum potassium measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Serologic tests serum potassium

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0302353
Serum sodium measurement value
Descrição

Serologic tests serum sodium

Tipo de dados

integer

Unidades de medida
  • mmol/l
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0523891
mmol/l
Is serum sodium measurement value within normal range?
Descrição

Serologic tests serum sodium

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0523891
Are serum sodium measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Serologic tests serum sodium

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0523891
Serum calcium measurement value
Descrição

Serologic tests serum calcium

Tipo de dados

integer

Unidades de medida
  • mmol/l
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0728876
mmol/l
Is serum calcium measurement value within normal range?
Descrição

Serologic tests serum calcium

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0728876
Are serum calcium measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Serologic measurement serum calcium

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0728876
Serum chloride measurement value
Descrição

Serologic tests serum chloride

Tipo de dados

integer

Unidades de medida
  • mmol/l
Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C1317978
mmol/l
Is serum chloride measurement value within normal range?
Descrição

Serologic tests serum chloride

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C1317978
Are serum chloride measurement findings clinically significant? If `Yes` , please fill in AE form.
Descrição

Serologic tests serum chloride

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C1317978
Hemoglobin measurement value
Descrição

Blood cell count: hemoglobin measurement

Tipo de dados

integer

Unidades de medida
  • g/dl
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0518015
g/dl
Is the hemoglobin measurement value within normal range?
Descrição

Blood cell count: hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0518015
Are hemoglobin measurement findings clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count: hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0518015
Hematocrit level
Descrição

Blood cell count hematocrit level

Tipo de dados

integer

Unidades de medida
  • %
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0518014
%
Is the hematocrit level within normal range?
Descrição

Blood cell count: Hematocrit level

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0518014
Are findings in hematocrit level clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count: Hematocrit level

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0518014
Erythrocyte measurement value
Descrição

Blood cell count: erythrocyte measurement

Tipo de dados

integer

Unidades de medida
  • mg/dl
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0014792
mg/dl
Is the erythrocyte measurement value within normal range?
Descrição

Blood cell count: erythrocyte measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0014792
Are findings in erythrocyte measurement clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count: erythrocyte measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0014792
Leukocyte measurement value
Descrição

Blood cell count: leukocyte measurement

Tipo de dados

integer

Unidades de medida
  • U/l
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0023516
U/l
Is the leukocyte measurement value within normal range?
Descrição

Blood cell count: leukocyte measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0023516
Are findings in Leukocyte measurement clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count:Leukocyte measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0023516
Absolute neutrophils count measurement value
Descrição

Blood cell count: Neutrophils count

Tipo de dados

integer

Unidades de medida
  • U/l
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0948762
U/l
Is the count of neutrophils within normal range?
Descrição

Blood cell count:neutrophils count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0948762
Are findings in neutrophils count clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count:neutrophils count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0948762
Lymphocyte count measurement value
Descrição

Blood cell count:lymphocyte count

Tipo de dados

integer

Unidades de medida
  • U/l
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0200635
U/l
Is the count of lymphocytes within normal range?
Descrição

Blood cell count:lymphocyte count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0200635
Are findings in lymphocyte count clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count:lymphocyte count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0200635
Monocyte measurement value
Descrição

Blood cell count: Monocyte count

Tipo de dados

integer

Unidades de medida
  • g/l
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0750880
g/l
Is the monocyte measurement value within normal range?
Descrição

Blood cell count: Monocyte count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0750880
Are findings in monocyte count clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count: Monocyte count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0750880
Eosinophils measurement value
Descrição

Blood cell count: Eosinophils count

Tipo de dados

integer

Unidades de medida
  • g/l
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0200638
g/l
Is the count of eosinophils within normal range?
Descrição

Blood cell count: Eosinophils count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0200638
Are findings in eosinophils count clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count: eosinophils count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0200638
Basophil measurement value
Descrição

Blood cell count: Basophil count

Tipo de dados

integer

Unidades de medida
  • g/l
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0200641
g/l
Is the count of basophils within normal range?
Descrição

Blood cell count: Basophil count

Tipo de dados

boolean

Are findings in basophil count clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count: Basophil count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0200641
Platelets count measurement value
Descrição

Blood cell count: platelets count

Tipo de dados

integer

Unidades de medida
  • g/l
Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0032181
g/l
Is the platelets count within normal range?
Descrição

Blood cell count: platelets count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0032181
Are findings in platelets count clinically significant? If `Yes`, please fill in AE form.
Descrição

Blood cell count: platelets count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0032181
Urine sample date and time
Descrição

Urine Sample Date

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200354
Urine Sample test results, if results are clinically significantly abnormal please fill in AE form.
Descrição

Urine Sample

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0456984
If urine sample test results are abnormal, please specify
Descrição

Urine sample test results

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0456984
Confirmation of correctness
Descrição

Confirmation of correctness

Name of Investigator
Descrição

Name of Investigator

Tipo de dados

text

Alias
UMLS CUI [1]
C0008961
Signature by investigator: I personally controlled all entries into this form for this patient. All data and statements in this CRF are complete and correct
Descrição

Signature

Tipo de dados

text

Alias
UMLS CUI [1]
C1519316
Date of completion of this form
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Case Report Form (HIPEC) Visit 6

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Visit 6:Day 7 post-surgery
Patient ID
Item
Patient ID
integer
C1269815 (UMLS CUI [1])
CRF number
Item
CRF number
integer
C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Item Group
Vital signs, concomitant medication and CTCAE
Heart rate
Item
Heart rate count
integer
C0018810 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Concomitant agent
Item
Has concomitant medication been subject to change? If `Yes` please fill in Concomitant medication form.
boolean
C2347852 (UMLS CUI [1])
CTCAE
Item
Recording of CTCAE: Have any AE occurred since the last Visit? If `Yes` please fill in AE-Form
boolean
C1516728 (UMLS CUI [1])
Item Group
Laboratory results
Date of venous blood sampling
Item
Date of venous blood sampling
date
C0190979 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of laboratory procedure
Item
Time of laboratory procedure (according to laboratory sheet)
time
C0022885 (UMLS CUI [1])
Serologic tests Creatinine
Item
Creatinine measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
Serologic tests Creatinine
Item
Is Creatinine value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
Serologic tests Creatinine
Item
Are Creatinine measurement findings clinically significant? If `Yes`, please fill in AE- form.
boolean
C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
Serologic tests Urea measurement
Item
Urea measurement value
integer
C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
Serologic tests Urea measurement
Item
Is Urea measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
Serologic tests Urea measurement
Item
Are Urea measurement findings clinically significant? If `Yes`, please fill in AE-Form.
boolean
C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
Serologic tests Bilirubin measurement
Item
Bilirubin measurement value
integer
C0036743 (UMLS CUI [1,1])
C0344395 (UMLS CUI [1,2])
Serologic tests Bilirubin measurement
Item
Is Bilirubin measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0344395 (UMLS CUI [1,2])
Serologic tests Bilirubin measurement
Item
Are Bilirubin measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C0344395 (UMLS CUI [1,2])
Serologic tests GPT measurement
Item
GPT measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
Serologic tests GPT measurement
Item
Is GPT value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
Serologic measurement GPT measurement
Item
Are GPT measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
Serologic tests GOT measurement
Item
GOT measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
Serologic tests GOT measurement
Item
Is GOT value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
Serologic tests GOT measurement
Item
Are GOT measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
Serologic tests GGT measurement
Item
GGT measurement value
integer
C0036743 (UMLS CUI [1,1])
C0202035 (UMLS CUI [1,2])
Serologic tests GGT Measurement
Item
Is GGT measurement within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0202035 (UMLS CUI [1,2])
Serologic tests GGT measurement
Item
Are GGT measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C0202035 (UMLS CUI [1,2])
Serologic tests Albumin measurement
Item
Albumin measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
Serologic tests Albumin measurement
Item
Is Albumin measurement within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
Serologic tests Albumin measurement
Item
Are Albumin measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
Serologic tests serum potassium
Item
Serum potassium measurement value
integer
C0036743 (UMLS CUI [1,1])
C0302353 (UMLS CUI [1,2])
Serologic tests serum potassium
Item
Is serum potassium measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0302353 (UMLS CUI [1,2])
Serologic tests serum potassium
Item
Are serum potassium measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C0302353 (UMLS CUI [1,2])
Serologic tests serum sodium
Item
Serum sodium measurement value
integer
C0036743 (UMLS CUI [1,1])
C0523891 (UMLS CUI [1,2])
Serologic tests serum sodium
Item
Is serum sodium measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0523891 (UMLS CUI [1,2])
Serologic tests serum sodium
Item
Are serum sodium measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C0523891 (UMLS CUI [1,2])
Serologic tests serum calcium
Item
Serum calcium measurement value
integer
C0036743 (UMLS CUI [1,1])
C0728876 (UMLS CUI [1,2])
Serologic tests serum calcium
Item
Is serum calcium measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0728876 (UMLS CUI [1,2])
Serologic measurement serum calcium
Item
Are serum calcium measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C0728876 (UMLS CUI [1,2])
Serologic tests serum chloride
Item
Serum chloride measurement value
integer
C0036743 (UMLS CUI [1,1])
C1317978 (UMLS CUI [1,2])
Serologic tests serum chloride
Item
Is serum chloride measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C1317978 (UMLS CUI [1,2])
Serologic tests serum chloride
Item
Are serum chloride measurement findings clinically significant? If `Yes` , please fill in AE form.
boolean
C0036743 (UMLS CUI [1,1])
C1317978 (UMLS CUI [1,2])
Blood cell count: hemoglobin measurement
Item
Hemoglobin measurement value
integer
C0005771 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
Blood cell count: hemoglobin measurement
Item
Is the hemoglobin measurement value within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
Blood cell count: hemoglobin measurement
Item
Are hemoglobin measurement findings clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
Blood cell count hematocrit level
Item
Hematocrit level
integer
C0005771 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
Blood cell count: Hematocrit level
Item
Is the hematocrit level within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
Blood cell count: Hematocrit level
Item
Are findings in hematocrit level clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
Blood cell count: erythrocyte measurement
Item
Erythrocyte measurement value
integer
C0005771 (UMLS CUI [1,1])
C0014792 (UMLS CUI [1,2])
Blood cell count: erythrocyte measurement
Item
Is the erythrocyte measurement value within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0014792 (UMLS CUI [1,2])
Blood cell count: erythrocyte measurement
Item
Are findings in erythrocyte measurement clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0014792 (UMLS CUI [1,2])
Blood cell count: leukocyte measurement
Item
Leukocyte measurement value
integer
C0005771 (UMLS CUI [1,1])
C0023516 (UMLS CUI [1,2])
Blood cell count: leukocyte measurement
Item
Is the leukocyte measurement value within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0023516 (UMLS CUI [1,2])
Blood cell count:Leukocyte measurement
Item
Are findings in Leukocyte measurement clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0023516 (UMLS CUI [1,2])
Blood cell count: Neutrophils count
Item
Absolute neutrophils count measurement value
integer
C0005771 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
Blood cell count:neutrophils count
Item
Is the count of neutrophils within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
Blood cell count:neutrophils count
Item
Are findings in neutrophils count clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
Blood cell count:lymphocyte count
Item
Lymphocyte count measurement value
integer
C0005771 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
Blood cell count:lymphocyte count
Item
Is the count of lymphocytes within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
Blood cell count:lymphocyte count
Item
Are findings in lymphocyte count clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
Blood cell count: Monocyte count
Item
Monocyte measurement value
integer
C0005771 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])
Blood cell count: Monocyte count
Item
Is the monocyte measurement value within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])
Blood cell count: Monocyte count
Item
Are findings in monocyte count clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])
Blood cell count: Eosinophils count
Item
Eosinophils measurement value
integer
C0005771 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
Blood cell count: Eosinophils count
Item
Is the count of eosinophils within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
Blood cell count: eosinophils count
Item
Are findings in eosinophils count clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
Blood cell count: Basophil count
Item
Basophil measurement value
integer
C0005771 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
Blood cell count: Basophil count
Item
Is the count of basophils within normal range?
boolean
Blood cell count: Basophil count
Item
Are findings in basophil count clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
Blood cell count: platelets count
Item
Platelets count measurement value
integer
C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
Blood cell count: platelets count
Item
Is the platelets count within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
Blood cell count: platelets count
Item
Are findings in platelets count clinically significant? If `Yes`, please fill in AE form.
boolean
C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
Urine Sample Date
Item
Urine sample date and time
datetime
C0011008 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Item
Urine Sample test results, if results are clinically significantly abnormal please fill in AE form.
text
C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine Sample
Code List
Urine Sample test results, if results are clinically significantly abnormal please fill in AE form.
CL Item
normal (1)
CL Item
abnormal, clinically not significant (2)
CL Item
abnormal, clinically significant (3)
Urine sample test results
Item
If urine sample test results are abnormal, please specify
text
C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Item Group
Confirmation of correctness
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
Signature
Item
Signature by investigator: I personally controlled all entries into this form for this patient. All data and statements in this CRF are complete and correct
text
C1519316 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
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