ID

13523

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 (3)
  1. 4/2/16 4/2/16 -
  2. 4/2/16 4/2/16 -
  3. 12/2/16 12/2/16 -
Subido en

12 de febrero de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Case Report Form (HIPEC)

1 formularios  
Visit 1: Screening visit and informed consent
Descripción

Visit 1: Screening visit and informed consent

Patient number
Descripción

Patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
CRF number
Descripción

CRF number

Tipo de datos

integer

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

Visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Date of informed consent
Descripción

Date of informed consent

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Patient received a copy of written and signed informed consent
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent for biobanking obtained
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Date of informed consent for biobanking
Descripción

Date of informed consent

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Year of birth
Descripción

Year of birth

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826771
Medical history of first cancer diagnosis
Descripción

Medical history of first cancer diagnosis

Date ovarian cancer was first diagnosed
Descripción

Date ovarian cancer was first diagnosed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C3172269
FIGO Staging at the point of first diagnosis
Descripción

FIGO Staging

Tipo de datos

text

Alias
UMLS CUI [1]
C0474961
Surgery
Descripción

Surgery

Has a debulking surgical procedure been performed?
Descripción

Debulking surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1706406
UMLS CUI [1,2]
C0543467
Please give the date the debulking procedure has been performed
Descripción

Date of debulking procedure

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1706406
Was there a residue after surgery?
Descripción

Residual tumor

Tipo de datos

text

Alias
UMLS CUI [1]
C0543478
Prior treatment
Descripción

Prior treatment

Did the patient already receive chemotherapy? If yes, please specify below
Descripción

Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
Chemotherapy regimen number
Descripción

Chemotherapy

Tipo de datos

integer

Alias
UMLS CUI [1]
C0392920
Which chemotherapeutic agents have been used?
Descripción

Chemotherapeutic agent

Tipo de datos

text

Alias
UMLS CUI [1]
C0729502
How has the chemotherapy been adminstered?
Descripción

Application route

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Chemotherapy Start Date
Descripción

Chemotherapy Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0392920
Chemotherapy End Date
Descripción

Chemotherapy End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0392920
Chemotherapy currently ongoing
Descripción

Chemotherapy currently ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2827774
UMLS CUI [1,2]
C0392920
Did the patient receive any other treatment for the ovarian cancer? If yes please specify below
Descripción

Other treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
What kind of treatment did the patient receive?
Descripción

Other treatment

Tipo de datos

text

Alias
UMLS CUI [1]
C0087111
Please specify any other treatment, not listed above
Descripción

Other treatment

Tipo de datos

text

Alias
UMLS CUI [1]
C0087111
Date of relapse diagnosis
Descripción

Date of relapse diagnosis

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0178760
UMLS CUI [1,2]
C0011008
Medical history
Descripción

Medical history

Which Body system are you referring to?
Descripción

Body System

Tipo de datos

text

Alias
UMLS CUI [1]
C0460002
Diagnosis or ICD-Code
Descripción

Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1]
C0011900
Please give the date, the condition was first diagnosed
Descripción

Date of onset

Tipo de datos

date

Alias
UMLS CUI [1]
C0574845
Please give the date the condition was cured
Descripción

End date of illness

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0221423
Persistent illness
Descripción

Persistent illness

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205322
UMLS CUI [1,2]
C0221423
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 Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Height
Descripción

Body Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body Mass Index
Descripción

BMI

Tipo de datos

float

Unidades de medida
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
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
Karnofsky performance status
Descripción

Karnofsky performance status

Tipo de datos

integer

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0206065
%
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
Does the patient currently use any other medication?If yes please specify on the enclosed concomitant medication form
Descripción

Concomitant Agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Date ECG was performed
Descripción

ECG Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
ECG findings
Descripción

ECG

Tipo de datos

text

Alias
UMLS CUI [1]
C0013798
Please specify any ECG findings
Descripción

ECG findings

Tipo de datos

text

Alias
UMLS CUI [1]
C0438154
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

Any findings in blood testing during the screening procedure have to be reviewed for In-/Exclusion criteria, but don´t have to be listed as adverse event.

Tipo de datos

time

Alias
UMLS CUI [1]
C0022885
Quick test result
Descripción

Blood coagulation series Quick test

Tipo de datos

integer

Unidades de medida
  • %
Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0086890
%
Quick test value at normal range?
Descripción

Blood coagulation series Quick test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0086890
Are Quick test findings clinically significant?
Descripción

Blood coagulation series Quick test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0086890
Prothrombin time ratio
Descripción

Blood coagulation series PTT

Tipo de datos

integer

Unidades de medida
  • sec
Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0491338
sec
Prothrombin time ratio within normal range?
Descripción

Blood coagulation series PTT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0491338
Are PTT findings clinically significant?
Descripción

Blood coagulation series PTT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0491338
INR test result
Descripción

Blood coagulation series INR

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0851084
INR test within normal range?
Descripción

Blood coagulation series INR

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0851084
Are INR test findings clinically significant?
Descripción

Blood coagulation series INR

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0851084
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
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?
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
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?
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?
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?
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?
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?
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?
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?
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?
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?
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?
Descripción

Serologic tests serum chloride

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C1317978
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 tumor marker CA 125 findings 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
Blood cell count
Descripción

Blood cell count

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?
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?
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?
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?
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?
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?
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?
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 eosinophils count 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?
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 basophil count within normal range?
Descripción

Blood cell count: Basophil count

Tipo de datos

boolean

Are findings in basophil count clinically significant?
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?
Descripción

Blood cell count: platelets count

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0032181
CTCAE Staging/Preexisting symptoms
Descripción

CTCAE Staging/Preexisting symptoms

Are there pre-existing symptoms?
Descripción

Pre-existing symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C1457887
Pre-existing constipation
Descripción

Pre-existing constipation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0009806
When did the constipation occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0009806
UMLS CUI [1,2]
C0574845
Pre-existing Dyspnea
Descripción

Pre-existing Dyspnea

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0013404
When did the Dyspnea occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0574845
Pre-existing fatigue
Descripción

Pre-existing fatigue

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0015672
When did the fatigue occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0574845
Pre-existing Edema
Descripción

Pre-existing Edema

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0013604
When did the edema occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013604
UMLS CUI [1,2]
C0574845
Pre-existing Lymphedema
Descripción

Pre-existing Lymphedema

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0024236
When did the lymphedema occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C0574845
Pre-existing lymphocele
Descripción

Pre-existing lymphocele

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0024248
When did the lymphocele occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0024248
UMLS CUI [1,2]
C0574845
Pre-existing sensory neuropathy
Descripción

Pre-existing sensory neuropathy

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0151313
When did the sensory neuropathy occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C0574845
Pre-existing motor neuropathy
Descripción

Pre-existing motor neuropathy

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C1135343
When did the motor neuropathy occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1135343
UMLS CUI [1,2]
C0574845
Pre-existing ascites
Descripción

Pre-existing ascites

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0003962
When did the ascites occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0574845
Pre-existing pleural effusion
Descripción

Pre-existing pleural effusion

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0080032
When did the pleural effusion occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0080032
UMLS CUI [1,2]
C0574845
Pre-existing pain
Descripción

Pre-existing pain

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0030193
When did the pain occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0574845
Pre-existing diarrhea
Descripción

Pre-existing diarrhea

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0011991
When did the diarrhea occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0574845
Pre-existing infection
Descripción

Pre-existing infection

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0009450
Please specify the kind of pre-existing infection
Descripción

Pre-existing infection

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0009450
When did the infection occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0574845
Pre-existing vomiting
Descripción

Pre-existing vomiting

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0042963
When did the vomiting occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0574845
Pre-existing oliguria and anuria
Descripción

Pre-existing oliguria and anuria

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0028962
When did the oliguria / anuria occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0028962
UMLS CUI [1,2]
C0574845
Pre-existing other symptoms
Descripción

Pre-existing other symptoms

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0029625
Please specify other pre-existing symptoms
Descripción

Other Symptoms

Tipo de datos

text

Alias
UMLS CUI [1]
C0029625
When did the symptom occur for the first time?
Descripción

Symptom onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0029625
UMLS CUI [1,2]
C0574845
Inclusion criteria
Descripción

Inclusion criteria

Patients must be ≥18 Years to ≤70 Years
Descripción

To be included into this trial, all criteria below must be answered "yes"

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Written informed consent given
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Patient is willing and able to comply to study protocol
Descripción

Compliance behavior

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
Patients with histologically confirmed or strong suspicion of ovarian carcinoma relapse
Descripción

To be treated according to this study protocol, patients must have the following kind of evaluation for tumor lesions: -measurable tumor lesions based on RECIST; Response Evaluation Criteria In Solid Tumors -not measurable tumor lesions based on tumor marker CA125 criteria according to Rustin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0277556
Treatment free interval after completion of primary treatment with platinum antineoplastic compounds ≥ 6 months
Descripción

Treatment free interval after treatment with platinum antineoplastic compounds

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C3536920
Known history and histologically confirmed diagnosis of ovarian carcinoma. (Initial diagnosis)
Descripción

Ovarian carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029925
Histologic differentiations qualifying for inclusion are:serous papillary adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma
Descripción

Ovarian carcinoma histologic differentiation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0205614
Karnofsky performance status must be greater than 70 percent.
Descripción

Karnofsky performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
Patient must be classified "operable"
Descripción

Patient must be classified "operable" with the meaning of resection of all tumor manifestations according to estimates by interdisciplinary tumor conference.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205188
Neutrophils must be ≥ 1,500/μl (equivalent of CTC grade 1)
Descripción

Neutrophils

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027950
Platelets must be ≥ 100,000/μl (CTC grade 0-1)
Descripción

Platelets

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005821
Creatinine must be ≤ 1.2 mg/dl
Descripción

Creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
Bilirubin ≤ 1.5 x upper level of normal (CTC Grade 1)
Descripción

Bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
AST ≤ 2.5 x upper level of normal (CTC Grade 1)
Descripción

AST

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
Sensory neuropathy ≤ CTC Grad 2
Descripción

Sensory neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151313
PT (INR) ≤ 1.5 (Exception: therapeutic antikoagulation- INR 2-3)
Descripción

INR

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525032
Exclusion criteria
Descripción

Exclusion criteria

Age younger than 18 years or older than 70 years
Descripción

All criteria must be answered "No" to qualify for the trial.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Informed Consent denied
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Patient is unable to understand extent, significance or consequences of this trial
Descripción

Informed consent limited

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
Patient is unable to follow protocol requirements
Descripción

Compliance behavior

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
Allergy or hypersensitivity against trial substance or chemically similar substances like Cisplatin or Carboplatin
Descripción

Allergy or hypersensitivity against trial substance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0008838
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0079083
Patient is currently or up to 30 days prior to enrollment participating in another clinical trial that includes the use of a trial substance
Descripción

Study subject participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
Known or current alcohol, prescription or illegal drug abuse
Descripción

Substance use disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
Current or planned pregnancy or breast feeding mothers
Descripción

Pregnancy or breast feeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Women of childbearing potential
Descripción

Childbearing potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
Fails to meet eligibility criteria in laboratory results
Descripción

Laboratory criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1254595
Patient has been judged "inoperable"
Descripción

Defined as resection of all manifestations of the tumor to be unlikely

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205187
Diagnose of mucinous ovarian carcinoma
Descripción

Mucinous ovarian carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1335167
New diagnose or relapse of a non-invasive borderline tumor
Descripción

non-invasive borderline tumor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0862506
UMLS CUI [1,2]
C2986496
Therapeutic radiology procedure of abdomen or pelvis
Descripción

Irradiation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
Therapeutic radiology procedure of Chest,Skin or Neck/Head for any malignancy less than 3 years ago
Descripción

Irradiation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
Any other acute malignancy or recurrent disease than the investigated indication
Descripción

Other acute malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
Acute infection
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
Patients with cardiac,pulmonary,renal,hepatic,metabolic,gastrointestinal,chronic or latent infectious or immunocompromising diseases that pose, at the discretion of the investigator, an intolerable risk to the patient
Descripción

Comorbidities

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
Any other circumstances that pose,at the descretion of the investigator, an unacceptable risk to the patient.
Descripción

Risk factor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035648
Patients with severely impaired renal function
Descripción

Kidney failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035078
Patients with hearing impairment
Descripción

Hearing impairment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1384666
Patients with a seizure disorder
Descripción

Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
Patients with preexisting neuropathy or motoric/sensory neurotoxicity (>CTC grade 2)
Descripción

Neuropathy or neurotoxicity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0442874
UMLS CUI [2]
C0235032
Patients with preexisting bone marrow depression
Descripción

Bone marrow depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151773
Patients with dehydration
Descripción

Dehydration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011175
Inclusion of Patient
Descripción

Inclusion of Patient

Patient will be included into this trial
Descripción

Inclusion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512693
Patient is excluded because
Descripción

Exclusion

Tipo de datos

text

Alias
UMLS CUI [1]
C2828389
If patient is excluded for other reasons, please specify below
Descripción

Exclusion

Tipo de datos

text

Alias
UMLS CUI [1]
C2828389
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)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Visit 1: Screening visit and informed consent
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
CRF number
Item
CRF number
integer
C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Visit date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Informed consent
Item
Patient received a copy of written and signed informed consent
boolean
C0021430 (UMLS CUI [1])
Informed Consent
Item
Informed Consent for biobanking obtained
boolean
C0021430 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent for biobanking
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Year of birth
Item
Year of birth
integer
C2826771 (UMLS CUI [1])
Item Group
Medical history of first cancer diagnosis
Date ovarian cancer was first diagnosed
Item
Date ovarian cancer was first diagnosed
date
C0029925 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
Item
FIGO Staging at the point of first diagnosis
text
C0474961 (UMLS CUI [1])
FIGO Staging
Code List
FIGO Staging at the point of first diagnosis
CL Item
I (0)
CL Item
I-A (1)
CL Item
I-B (2)
CL Item
I-C (3)
CL Item
II (4)
CL Item
II-A (5)
CL Item
II-B (6)
CL Item
III (7)
CL Item
III-A (8)
CL Item
III-A1 (9)
CL Item
III-A1i (10)
CL Item
III-A1ii (11)
CL Item
III-A2 (12)
CL Item
III-B (13)
CL Item
III-C (14)
CL Item
IV (15)
CL Item
IV-A (16)
CL Item
IV-B (17)
Item Group
Surgery
Debulking surgery
Item
Has a debulking surgical procedure been performed?
boolean
C1706406 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Date of debulking procedure
Item
Please give the date the debulking procedure has been performed
date
C0011008 (UMLS CUI [1,1])
C1706406 (UMLS CUI [1,2])
Item
Was there a residue after surgery?
text
C0543478 (UMLS CUI [1])
Residual tumor
Code List
Was there a residue after surgery?
CL Item
no residue (microscopic) (0)
CL Item
<1cm residual tumor  (1)
CL Item
≥1cm residual tumor (2)
Item Group
Prior treatment
Chemotherapy
Item
Did the patient already receive chemotherapy? If yes, please specify below
boolean
C0392920 (UMLS CUI [1])
Chemotherapy
Item
Chemotherapy regimen number
integer
C0392920 (UMLS CUI [1])
Chemotherapeutic agent
Item
Which chemotherapeutic agents have been used?
text
C0729502 (UMLS CUI [1])
Item
How has the chemotherapy been adminstered?
text
C0013153 (UMLS CUI [1])
Application route
Code List
How has the chemotherapy been adminstered?
CL Item
intravenous (1)
CL Item
intraperitoneally (2)
CL Item
other (3)
Chemotherapy Start Date
Item
Chemotherapy Start Date
date
C0808070 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Chemotherapy End Date
Item
Chemotherapy End Date
date
C0806020 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Chemotherapy currently ongoing
Item
Chemotherapy currently ongoing
boolean
C2827774 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Other treatment
Item
Did the patient receive any other treatment for the ovarian cancer? If yes please specify below
boolean
C0087111 (UMLS CUI [1])
Item
What kind of treatment did the patient receive?
text
C0087111 (UMLS CUI [1])
Other treatment
Code List
What kind of treatment did the patient receive?
CL Item
hormone/biological (1)
CL Item
antineoplastic immunotherapy (2)
CL Item
radiotherapy (3)
CL Item
other (4)
Other treatment
Item
Please specify any other treatment, not listed above
text
C0087111 (UMLS CUI [1])
Date of relapse diagnosis
Item
Date of relapse diagnosis
date
C0178760 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Medical history
Item
Which Body system are you referring to?
text
C0460002 (UMLS CUI [1])
Body System
Code List
Which Body system are you referring to?
CL Item
eyes,nose,ears,throat (1)
CL Item
cardiovascular system (2)
CL Item
respiratory tract (3)
CL Item
gastrointestinal system, liver (4)
CL Item
gynaecological incl breasts (5)
CL Item
neurological disorder (6)
CL Item
hematology (7)
CL Item
endocrine system (8)
CL Item
musculoskeletal system (9)
CL Item
skin (10)
CL Item
allergies/hypersensitivities (11)
CL Item
urinary tract (12)
CL Item
other (13)
Diagnosis
Item
Diagnosis or ICD-Code
text
C0011900 (UMLS CUI [1])
Date of onset
Item
Please give the date, the condition was first diagnosed
date
C0574845 (UMLS CUI [1])
End date of illness
Item
Please give the date the condition was cured
date
C0806020 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
Persistent illness
Item
Persistent illness
boolean
C0205322 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
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 Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
BMI
Item
Body Mass Index
float
C1305855 (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)
Karnofsky performance status
Item
Karnofsky performance status
integer
C0206065 (UMLS CUI [1])
Item
General physical condition
text
C1142435 (UMLS CUI [1])
General 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
Does the patient currently use any other medication?If yes please specify on the enclosed concomitant medication form
boolean
C2347852 (UMLS CUI [1])
ECG Date
Item
Date ECG was performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
ECG findings
text
C0013798 (UMLS CUI [1])
ECG
Code List
ECG findings
CL Item
normal (1)
CL Item
pathological, clinically not significant (please specify below) (2)
CL Item
pathological, clinically significant (please specify below) (3)
ECG findings
Item
Please specify any ECG findings
text
C0438154 (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])
Blood coagulation series Quick test
Item
Quick test result
integer
C0005790 (UMLS CUI [1,1])
C0086890 (UMLS CUI [1,2])
Blood coagulation series Quick test
Item
Quick test value at normal range?
boolean
C0005790 (UMLS CUI [1,1])
C0086890 (UMLS CUI [1,2])
Blood coagulation series Quick test
Item
Are Quick test findings clinically significant?
boolean
C0005790 (UMLS CUI [1,1])
C0086890 (UMLS CUI [1,2])
Blood coagulation series PTT
Item
Prothrombin time ratio
integer
C0005790 (UMLS CUI [1,1])
C0491338 (UMLS CUI [1,2])
Blood coagulation series PTT
Item
Prothrombin time ratio within normal range?
boolean
C0005790 (UMLS CUI [1,1])
C0491338 (UMLS CUI [1,2])
Blood coagulation series PTT
Item
Are PTT findings clinically significant?
boolean
C0005790 (UMLS CUI [1,1])
C0491338 (UMLS CUI [1,2])
Blood coagulation series INR
Item
INR test result
integer
C0005790 (UMLS CUI [1,1])
C0851084 (UMLS CUI [1,2])
Blood coagulation series INR
Item
INR test within normal range?
boolean
C0005790 (UMLS CUI [1,1])
C0851084 (UMLS CUI [1,2])
Blood coagulation series INR
Item
Are INR test findings clinically significant?
boolean
C0005790 (UMLS CUI [1,1])
C0851084 (UMLS CUI [1,2])
Serologic tests Creatinine
Item
Creatinine measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
Serologic tests Creatinine
Item
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?
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
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?
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?
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?
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?
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?
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?
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?
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?
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?
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?
boolean
C0036743 (UMLS CUI [1,1])
C1317978 (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 tumor marker CA 125 findings 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
Blood cell count
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?
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?
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?
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?
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?
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?
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?
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 eosinophils count 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?
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 basophil count within normal range?
boolean
Blood cell count: Basophil count
Item
Are findings in basophil count clinically significant?
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?
boolean
C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
Item Group
CTCAE Staging/Preexisting symptoms
Pre-existing symptoms
Item
Are there pre-existing symptoms?
boolean
C2347662 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Item
Pre-existing constipation
text
C2347662 (UMLS CUI [1,1])
C0009806 (UMLS CUI [1,2])
Pre-existing constipation
Code List
Pre-existing constipation
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the constipation occur for the first time?
date
C0009806 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing Dyspnea
text
C2347662 (UMLS CUI [1,1])
C0013404 (UMLS CUI [1,2])
Pre-existing Dyspnea
Code List
Pre-existing Dyspnea
CL Item
mild  (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the Dyspnea occur for the first time?
date
C0013404 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing fatigue
text
C2347662 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Pre-existing fatigue
Code List
Pre-existing fatigue
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the fatigue occur for the first time?
date
C0015672 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing Edema
text
C2347662 (UMLS CUI [1,1])
C0013604 (UMLS CUI [1,2])
Pre-existing Edema
Code List
Pre-existing Edema
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the edema occur for the first time?
date
C0013604 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing Lymphedema
text
C2347662 (UMLS CUI [1,1])
C0024236 (UMLS CUI [1,2])
Pre-existing Lymphedema
Code List
Pre-existing Lymphedema
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the lymphedema occur for the first time?
date
C0024236 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing lymphocele
text
C2347662 (UMLS CUI [1,1])
C0024248 (UMLS CUI [1,2])
Pre-existing lymphocele
Code List
Pre-existing lymphocele
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the lymphocele occur for the first time?
date
C0024248 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing sensory neuropathy
text
C2347662 (UMLS CUI [1,1])
C0151313 (UMLS CUI [1,2])
Pre-existing sensory neuropathy
Code List
Pre-existing sensory neuropathy
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the sensory neuropathy occur for the first time?
date
C0151313 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing motor neuropathy
text
C2347662 (UMLS CUI [1,1])
C1135343 (UMLS CUI [1,2])
Pre-existing motoric neuropathy
Code List
Pre-existing motor neuropathy
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the motor neuropathy occur for the first time?
date
C1135343 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing ascites
text
C2347662 (UMLS CUI [1,1])
C0003962 (UMLS CUI [1,2])
Pre-existing ascites
Code List
Pre-existing ascites
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the ascites occur for the first time?
date
C0003962 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing pleural effusion
text
C2347662 (UMLS CUI [1,1])
C0080032 (UMLS CUI [1,2])
Pre-existing pleural effusion
Code List
Pre-existing pleural effusion
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the pleural effusion occur for the first time?
date
C0080032 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing pain
text
C2347662 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Pre-existing pain
Code List
Pre-existing pain
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the pain occur for the first time?
date
C0030193 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing diarrhea
text
C2347662 (UMLS CUI [1,1])
C0011991 (UMLS CUI [1,2])
Pre-existing diarrhea
Code List
Pre-existing diarrhea
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the diarrhea occur for the first time?
date
C0011991 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing infection
text
C2347662 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Pre-existing infection
Code List
Pre-existing infection
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Pre-existing infection
Item
Please specify the kind of pre-existing infection
text
C2347662 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Symptom onset
Item
When did the infection occur for the first time?
date
C0009450 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing vomiting
text
C2347662 (UMLS CUI [1,1])
C0042963 (UMLS CUI [1,2])
Pre-existing vomiting
Code List
Pre-existing vomiting
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the vomiting occur for the first time?
date
C0042963 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing oliguria and anuria
text
C2347662 (UMLS CUI [1,1])
C0028962 (UMLS CUI [1,2])
Pre-existing oliguria and anuria
Code List
Pre-existing oliguria and anuria
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the oliguria / anuria occur for the first time?
date
C0028962 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing other symptoms
text
C2347662 (UMLS CUI [1,1])
C0029625 (UMLS CUI [1,2])
Pre-existing other symptoms
Code List
Pre-existing other symptoms
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Other Symptoms
Item
Please specify other pre-existing symptoms
text
C0029625 (UMLS CUI [1])
Symptom onset
Item
When did the symptom occur for the first time?
date
C0029625 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item Group
Inclusion criteria
Age
Item
Patients must be ≥18 Years to ≤70 Years
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
Written informed consent given
boolean
C0021430 (UMLS CUI [1])
Compliance behavior
Item
Patient is willing and able to comply to study protocol
boolean
C1321605 (UMLS CUI [1])
Ovarian carcinoma relapse
Item
Patients with histologically confirmed or strong suspicion of ovarian carcinoma relapse
boolean
C0029925 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Treatment free interval after treatment with platinum antineoplastic compounds
Item
Treatment free interval after completion of primary treatment with platinum antineoplastic compounds ≥ 6 months
boolean
C0872291 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C3536920 (UMLS CUI [1,3])
Ovarian carcinoma
Item
Known history and histologically confirmed diagnosis of ovarian carcinoma. (Initial diagnosis)
boolean
C0029925 (UMLS CUI [1])
Ovarian carcinoma histologic differentiation
Item
Histologic differentiations qualifying for inclusion are:serous papillary adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma
boolean
C0029925 (UMLS CUI [1,1])
C0205614 (UMLS CUI [1,2])
Karnofsky performance status
Item
Karnofsky performance status must be greater than 70 percent.
boolean
C0206065 (UMLS CUI [1])
Patient must be classified "operable"
Item
Patient must be classified "operable"
boolean
C0205188 (UMLS CUI [1])
Neutrophils
Item
Neutrophils must be ≥ 1,500/μl (equivalent of CTC grade 1)
boolean
C0027950 (UMLS CUI [1])
Platelets
Item
Platelets must be ≥ 100,000/μl (CTC grade 0-1)
boolean
C0005821 (UMLS CUI [1])
Creatinine
Item
Creatinine must be ≤ 1.2 mg/dl
boolean
C0201976 (UMLS CUI [1])
Bilirubin
Item
Bilirubin ≤ 1.5 x upper level of normal (CTC Grade 1)
boolean
C1278039 (UMLS CUI [1])
AST
Item
AST ≤ 2.5 x upper level of normal (CTC Grade 1)
boolean
C0201899 (UMLS CUI [1])
Sensory neuropathy
Item
Sensory neuropathy ≤ CTC Grad 2
boolean
C0151313 (UMLS CUI [1])
INR
Item
PT (INR) ≤ 1.5 (Exception: therapeutic antikoagulation- INR 2-3)
boolean
C0525032 (UMLS CUI [1])
Item Group
Exclusion criteria
Age
Item
Age younger than 18 years or older than 70 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Informed Consent denied
boolean
C0021430 (UMLS CUI [1])
Informed consent limited
Item
Patient is unable to understand extent, significance or consequences of this trial
boolean
C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Compliance behavior
Item
Patient is unable to follow protocol requirements
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Allergy or hypersensitivity against trial substance
Item
Allergy or hypersensitivity against trial substance or chemically similar substances like Cisplatin or Carboplatin
boolean
C0020517 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0079083 (UMLS CUI [2,2])
Study subject participation status
Item
Patient is currently or up to 30 days prior to enrollment participating in another clinical trial that includes the use of a trial substance
boolean
C2348568 (UMLS CUI [1])
Substance use disorder
Item
Known or current alcohol, prescription or illegal drug abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy or breast feeding
Item
Current or planned pregnancy or breast feeding mothers
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Childbearing potential
Item
Women of childbearing potential
boolean
C3831118 (UMLS CUI [1])
Laboratory criteria
Item
Fails to meet eligibility criteria in laboratory results
boolean
C1516637 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Patient judged "inoperable"
Item
Patient has been judged "inoperable"
boolean
C0205187 (UMLS CUI [1])
Mucinous ovarian carcinoma
Item
Diagnose of mucinous ovarian carcinoma
boolean
C1335167 (UMLS CUI [1])
non-invasive borderline tumor
Item
New diagnose or relapse of a non-invasive borderline tumor
boolean
C0862506 (UMLS CUI [1,1])
C2986496 (UMLS CUI [1,2])
Irradiation
Item
Therapeutic radiology procedure of abdomen or pelvis
boolean
C1522449 (UMLS CUI [1])
Irradiation
Item
Therapeutic radiology procedure of Chest,Skin or Neck/Head for any malignancy less than 3 years ago
boolean
C1522449 (UMLS CUI [1])
Other acute malignancy
Item
Any other acute malignancy or recurrent disease than the investigated indication
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Infection
Item
Acute infection
boolean
C0009450 (UMLS CUI [1])
Comorbidities
Item
Patients with cardiac,pulmonary,renal,hepatic,metabolic,gastrointestinal,chronic or latent infectious or immunocompromising diseases that pose, at the discretion of the investigator, an intolerable risk to the patient
boolean
C0009488 (UMLS CUI [1])
Risk factor
Item
Any other circumstances that pose,at the descretion of the investigator, an unacceptable risk to the patient.
boolean
C0035648 (UMLS CUI [1])
Kidney failure
Item
Patients with severely impaired renal function
boolean
C0035078 (UMLS CUI [1])
Hearing impairment
Item
Patients with hearing impairment
boolean
C1384666 (UMLS CUI [1])
Epilepsy
Item
Patients with a seizure disorder
boolean
C0014544 (UMLS CUI [1])
Neuropathy or neurotoxicity
Item
Patients with preexisting neuropathy or motoric/sensory neurotoxicity (>CTC grade 2)
boolean
C0442874 (UMLS CUI [1])
C0235032 (UMLS CUI [2])
Bone marrow depression
Item
Patients with preexisting bone marrow depression
boolean
C0151773 (UMLS CUI [1])
Dehydration
Item
Patients with dehydration
boolean
C0011175 (UMLS CUI [1])
Item Group
Inclusion of Patient
Inclusion
Item
Patient will be included into this trial
boolean
C1512693 (UMLS CUI [1])
Item
Patient is excluded because
text
C2828389 (UMLS CUI [1])
Exclusion
Code List
Patient is excluded because
CL Item
informed consent has been withdrawn (1)
CL Item
In-/Exclusion criteria have not been met (2)
CL Item
other (3)
Exclusion
Item
If patient is excluded for other reasons, please specify below
text
C2828389 (UMLS CUI [1])
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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