ID

13565

Descripción

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

Palabras clave

Versiones (1)
  1. 16/2/16 16/2/16 -
Subido en

16 de febrero de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Visit 8 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv

Inglés

Case Report Form (HIPEC) Visit 8

1 formularios  
Visit 8: Day 21 post-OP
Descripción

Visit 8: Day 21 post-OP

Patient ID
Descripción

Patient ID

Tipo de datos

integer

Alias
UMLS CUI [1]
C1269815
CRF number
Descripción

CRF number

Tipo de datos

integer

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

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Vital signs and physical examination
Descripción

Vital signs and physical examination

Heart rate count
Descripción

Heart rate

Tipo de datos

integer

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

Blood pressure

Tipo de datos

text

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

Body Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Performance status (ECOG):
Descripción

ECOG

Tipo de datos

text

Alias
UMLS CUI [1]
C1520224
General physical condition
Descripción

General physical condition

Tipo de datos

text

Alias
UMLS CUI [1]
C1142435
General physical condition:further comment
Descripción

General physical condition

Tipo de datos

text

Alias
UMLS CUI [1]
C1142435
Skin assessment
Descripción

Skin assessment

Tipo de datos

text

Alias
UMLS CUI [1]
C0419929
Skin assessment:further comment
Descripción

Skin assessment

Tipo de datos

text

Alias
UMLS CUI [1]
C0419929
Cardiovascular system assessment
Descripción

Cardiovascular system

Tipo de datos

text

Alias
UMLS CUI [1]
C0007226
Cardiovascular system:further comment
Descripción

Cardiovascular system

Tipo de datos

text

Alias
UMLS CUI [1]
C0007226
Respiratory system assessment
Descripción

Respiratory system

Tipo de datos

text

Alias
UMLS CUI [1]
C0035237
Respiratory System:further comment
Descripción

Respiratory system

Tipo de datos

text

Alias
UMLS CUI [1]
C0035237
Otorhinolaryngologic diseases
Descripción

Otorhinolaryngologic diseases

Tipo de datos

text

Alias
UMLS CUI [1]
C0029896
Otorhinolaryngologic diseases:further comment
Descripción

Otorhinolaryngologic diseases

Tipo de datos

text

Alias
UMLS CUI [1]
C0029896
Abdominal examination
Descripción

Abdominal examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0438120
Abdominal examination:further comment
Descripción

Abdominal examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0438120
Lymphatic system
Descripción

Lymphatic system

Tipo de datos

text

Alias
UMLS CUI [1]
C0024235
Lymphatic system:further comment
Descripción

Lymphatic system

Tipo de datos

text

Alias
UMLS CUI [1]
C0024235
Mucous Membranes
Descripción

Mucous Membranes

Tipo de datos

text

Alias
UMLS CUI [1]
C0026724
Mucous Membranes:further comment
Descripción

Mucous Membranes

Tipo de datos

text

Alias
UMLS CUI [1]
C0026724
Neurological examination
Descripción

Neurological examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0027853
Neurological examination:further comment
Descripción

Neurological examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0027853
Gynecological Examination
Descripción

Gynecological Examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0200044
Gynecological Examination:further comment
Descripción

Gynecological Examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0200044
Urinary Tract and Kidney Examination
Descripción

Urinary Tract and Kidney

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042027
UMLS CUI [1,2]
C0227665
Urinary Tract and Kidneys:further comment
Descripción

Urinary Tract and Kidneys

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042027
UMLS CUI [1,2]
C0227665
Please specify any other clinically significant findings
Descripción

Other Findings

Tipo de datos

text

Alias
UMLS CUI [1]
C0159135
Has concomitant medication been subject to change? If "Yes", please fill in concomitant medication form.
Descripción

Concomitant agent

Tipo de datos

boolean

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

CTCAE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516728
Laboratory results
Descripción

Laboratory results

Date of venous blood sampling
Descripción

First venipuncture of that day

Tipo de datos

date

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

Time of laboratory procedure

Tipo de datos

time

Alias
UMLS CUI [1]
C0022885
Creatinine measurement value
Descripción

Serologic tests Creatinine

Tipo de datos

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?
Descripción

Serologic tests Creatinine

Tipo de datos

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.
Descripción

Serologic tests Creatinine

Tipo de datos

boolean

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

Serologic tests Urea measurement

Tipo de datos

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?
Descripción

Serologic tests Urea measurement

Tipo de datos

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.
Descripción

Serologic tests Urea measurement

Tipo de datos

boolean

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

Serologic tests Bilirubin measurement

Tipo de datos

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?
Descripción

Serologic tests Bilirubin measurement

Tipo de datos

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.
Descripción

Serologic tests Bilirubin measurement

Tipo de datos

boolean

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

Serologic tests GPT measurement

Tipo de datos

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?
Descripción

Serologic tests GPT measurement

Tipo de datos

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.
Descripción

Serologic measurement GPT measurement

Tipo de datos

boolean

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

Serologic tests GOT measurement

Tipo de datos

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?
Descripción

Serologic tests GOT measurement

Tipo de datos

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.
Descripción

Serologic tests GOT measurement

Tipo de datos

boolean

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

Serologic tests GGT measurement

Tipo de datos

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?
Descripción

Serologic tests GGT Measurement

Tipo de datos

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.
Descripción

Serologic tests GGT measurement

Tipo de datos

boolean

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

Serologic tests Albumin measurement

Tipo de datos

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?
Descripción

Serologic tests Albumin measurement

Tipo de datos

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.
Descripción

Serologic tests Albumin measurement

Tipo de datos

boolean

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

Serologic tests serum potassium

Tipo de datos

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?
Descripción

Serologic tests serum potassium

Tipo de datos

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.
Descripción

Serologic tests serum potassium

Tipo de datos

boolean

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

Serologic tests serum sodium

Tipo de datos

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?
Descripción

Serologic tests serum sodium

Tipo de datos

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.
Descripción

Serologic tests serum sodium

Tipo de datos

boolean

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

Serologic tests serum calcium

Tipo de datos

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?
Descripción

Serologic tests serum calcium

Tipo de datos

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.
Descripción

Serologic measurement serum calcium

Tipo de datos

boolean

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

Serologic tests serum chloride

Tipo de datos

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?
Descripción

Serologic tests serum chloride

Tipo de datos

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.
Descripción

Serologic tests serum chloride

Tipo de datos

boolean

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

Blood cell count: hemoglobin measurement

Tipo de datos

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?
Descripción

Blood cell count: hemoglobin measurement

Tipo de datos

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.
Descripción

Blood cell count: hemoglobin measurement

Tipo de datos

boolean

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

Blood cell count hematocrit level

Tipo de datos

integer

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

Blood cell count: Hematocrit level

Tipo de datos

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.
Descripción

Blood cell count: Hematocrit level

Tipo de datos

boolean

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

Blood cell count: erythrocyte measurement

Tipo de datos

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?
Descripción

Blood cell count: erythrocyte measurement

Tipo de datos

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.
Descripción

Blood cell count: erythrocyte measurement

Tipo de datos

boolean

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

Blood cell count: leukocyte measurement

Tipo de datos

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?
Descripción

Blood cell count: leukocyte measurement

Tipo de datos

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.
Descripción

Blood cell count:Leukocyte measurement

Tipo de datos

boolean

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

Blood cell count: Neutrophils count

Tipo de datos

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?
Descripción

Blood cell count:neutrophils count

Tipo de datos

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.
Descripción

Blood cell count:neutrophils count

Tipo de datos

boolean

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

Blood cell count:lymphocyte count

Tipo de datos

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?
Descripción

Blood cell count:lymphocyte count

Tipo de datos

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.
Descripción

Blood cell count:lymphocyte count

Tipo de datos

boolean

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

Blood cell count: Monocyte count

Tipo de datos

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?
Descripción

Blood cell count: Monocyte count

Tipo de datos

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.
Descripción

Blood cell count: Monocyte count

Tipo de datos

boolean

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

Blood cell count: Eosinophils count

Tipo de datos

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?
Descripción

Blood cell count: Eosinophils count

Tipo de datos

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.
Descripción

Blood cell count: eosinophils count

Tipo de datos

boolean

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

Blood cell count: Basophil count

Tipo de datos

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?
Descripción

Blood cell count: Basophil count

Tipo de datos

boolean

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

Blood cell count: Basophil count

Tipo de datos

boolean

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

Blood cell count: platelets count

Tipo de datos

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?
Descripción

Blood cell count: platelets count

Tipo de datos

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.
Descripción

Blood cell count: platelets count

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0032181
Tumor marker CA125 measurement value
Descripción

Tumor marker measurement

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0474700
UMLS CUI [1,2]
C0973166
Is measurement value of tumor marker CA 125 within normal range?
Descripción

Tumor marker measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0474700
UMLS CUI [1,2]
C0973166
Are findings in tumor marker CA 125 clinically significant?
Descripción

Tumor marker measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0474700
UMLS CUI [1,2]
C0973166
Urine sample date and time
Descripción

Urine Sample Date

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200354
Urine Sample test results
Descripción

Urine Sample

Tipo de datos

text

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

Urine sample test results

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0456984
Inquiry of dose limiting toxicity
Descripción

Inquiry of dose limiting toxicity

Has a dose limiting toxicity been reached?
Descripción

Answer only after consultation with data and safety monitoring board (DSMB).

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512043
UMLS CUI [1,2]
C0013221
If dose limiting toxicity has been reached, please specify the date it occurred
Descripción

Date of dose limiting toxicity

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1512043
UMLS CUI [1,3]
C0013221
Please specify the toxicities that have occurred and give the corresponding AE number
Descripción

Dose limiting toxicity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1512043
UMLS CUI [1,2]
C0013221
Has maximum tolerated dose been reached?
Descripción

Answer only after consultation with data and safety monitoring board (DSMB).

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0752079
Confirmation of correctness
Descripción

Confirmation of correctness

Name of Investigator
Descripción

Name of Investigator

Tipo de datos

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
Descripción

Signature

Tipo de datos

text

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

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Case Report Form (HIPEC) Visit 8

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Visit 8: Day 21 post-OP
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 and physical examination
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])
Item
Performance status (ECOG):
text
C1520224 (UMLS CUI [1])
ECOG
Code List
Performance status (ECOG):
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
General physical condition
text
C1142435 (UMLS CUI [1])
General physical condition
Code List
General physical condition
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
General physical condition
Item
General physical condition:further comment
text
C1142435 (UMLS CUI [1])
Item
Skin assessment
text
C0419929 (UMLS CUI [1])
Skin assessment
Code List
Skin assessment
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Skin assessment
Item
Skin assessment:further comment
text
C0419929 (UMLS CUI [1])
Item
Cardiovascular system assessment
text
C0007226 (UMLS CUI [1])
Cardiovascular system
Code List
Cardiovascular system assessment
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Cardiovascular system
Item
Cardiovascular system:further comment
text
C0007226 (UMLS CUI [1])
Item
Respiratory system assessment
text
C0035237 (UMLS CUI [1])
Respiratory system
Code List
Respiratory system assessment
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Respiratory system
Item
Respiratory System:further comment
text
C0035237 (UMLS CUI [1])
Item
Otorhinolaryngologic diseases
text
C0029896 (UMLS CUI [1])
Otorhinolaryngologic diseases
Code List
Otorhinolaryngologic diseases
CL Item
none (1)
CL Item
yes (2)
CL Item
not assessed (3)
Otorhinolaryngologic diseases
Item
Otorhinolaryngologic diseases:further comment
text
C0029896 (UMLS CUI [1])
Item
Abdominal examination
text
C0438120 (UMLS CUI [1])
Abdominal examination
Code List
Abdominal examination
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Abdominal examination
Item
Abdominal examination:further comment
text
C0438120 (UMLS CUI [1])
Item
Lymphatic system
text
C0024235 (UMLS CUI [1])
Lymphatic system
Code List
Lymphatic system
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Lymphatic system
Item
Lymphatic system:further comment
text
C0024235 (UMLS CUI [1])
Item
Mucous Membranes
text
C0026724 (UMLS CUI [1])
Mucous Membranes
Code List
Mucous Membranes
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Mucous Membranes
Item
Mucous Membranes:further comment
text
C0026724 (UMLS CUI [1])
Item
Neurological examination
text
C0027853 (UMLS CUI [1])
Neurological examination
Code List
Neurological examination
CL Item
Normal (1)
CL Item
Pathological (2)
CL Item
not assessed (3)
Neurological examination
Item
Neurological examination:further comment
text
C0027853 (UMLS CUI [1])
Item
Gynecological Examination
text
C0200044 (UMLS CUI [1])
Gynecological Examination
Code List
Gynecological Examination
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Gynecological Examination
Item
Gynecological Examination:further comment
text
C0200044 (UMLS CUI [1])
Item
Urinary Tract and Kidney Examination
text
C0042027 (UMLS CUI [1,1])
C0227665 (UMLS CUI [1,2])
Urinary Tract and Kidney
Code List
Urinary Tract and Kidney Examination
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Urinary Tract and Kidneys
Item
Urinary Tract and Kidneys:further comment
text
C0042027 (UMLS CUI [1,1])
C0227665 (UMLS CUI [1,2])
Other Findings
Item
Please specify any other clinically significant findings
text
C0159135 (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])
Tumor marker measurement
Item
Tumor marker CA125 measurement value
integer
C0474700 (UMLS CUI [1,1])
C0973166 (UMLS CUI [1,2])
Tumor marker measurement
Item
Is measurement value of tumor marker CA 125 within normal range?
boolean
C0474700 (UMLS CUI [1,1])
C0973166 (UMLS CUI [1,2])
Tumor marker measurement
Item
Are findings in tumor marker CA 125 clinically significant?
boolean
C0474700 (UMLS CUI [1,1])
C0973166 (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
text
C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine Sample
Code List
Urine Sample test results
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
Inquiry of dose limiting toxicity
Dose limiting toxicity
Item
Has a dose limiting toxicity been reached?
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
Date of dose limiting toxicity
Item
If dose limiting toxicity has been reached, please specify the date it occurred
date
C0011008 (UMLS CUI [1,1])
C1512043 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
Dose limiting toxicity
Item
Please specify the toxicities that have occurred and give the corresponding AE number
text
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
Maximum tolerated dose
Item
Has maximum tolerated dose been reached?
boolean
C0752079 (UMLS CUI [1])
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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