ID
13570
Description
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
Keywords
Versions (1)
- 2/17/16 2/17/16 -
Uploaded on
February 17, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Visit 11 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv
Case Report Form (HIPEC) Visit 11
- StudyEvent: ODM
Description
Status of Patient and recording of CTCAE
Description
Patient Visit
Data type
boolean
Alias
- UMLS CUI [1]
- C1512346
Description
Patient visit
Data type
text
Alias
- UMLS CUI [1]
- C1512346
Description
Patient deceased
Data type
boolean
Alias
- UMLS CUI [1]
- C1555024
Description
Date of death
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0011065
Description
Progressive disease
Data type
boolean
Alias
- UMLS CUI [1]
- C1335499
Description
Progressive Disease date
Data type
date
Alias
- UMLS CUI [1,1]
- C1335499
- UMLS CUI [1,2]
- C0011008
Description
Relapse
Data type
boolean
Alias
- UMLS CUI [1]
- C0277556
Description
Date of relapse
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035020
- UMLS CUI [1,2]
- C0011008
Description
CTCAE
Data type
boolean
Alias
- UMLS CUI [1]
- C1516728
Description
Postoperative intravenous chemotherapy
Description
Postoperative chemotherapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032790
- UMLS CUI [1,2]
- C0392920
Description
Postoperative chemotherapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0032790
- UMLS CUI [1,2]
- C0392920
Description
Postoperative chemotherapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0032790
- UMLS CUI [1,2]
- C0392920
Description
Postoperative chemotherapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0032790
- UMLS CUI [1,2]
- C0392920
Description
Other antineoplastic agent
Data type
text
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C0205394
Description
Carboplatin
Data type
float
Measurement units
- AUC
Alias
- UMLS CUI [1]
- C0079083
Description
Paclitaxel
Data type
float
Measurement units
- mg/m2
Alias
- UMLS CUI [1]
- C0144576
Description
Gemcitabine
Data type
float
Measurement units
- mg/m2
Alias
- UMLS CUI [1]
- C0045093
Description
Doxorubicin liposome
Data type
float
Measurement units
- mg/m2
Alias
- UMLS CUI [1]
- C0717726
Description
Other antineoplastic agent
Data type
float
Measurement units
- mg/m2
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C0205394
Description
Course of chemotherapy cycle
Description
Date of third chemotherapy
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0392920
Description
Total dose of antineoplastic agent
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C0178602
Description
Dose modification
Data type
boolean
Alias
- UMLS CUI [1]
- C1707811
Description
Dose modification
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
The reason for dose modification is an AE that has to be documented appropriately on the AE form.
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
Total dose of antineoplastic agent
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C0178602
Description
Dose modification
Data type
boolean
Alias
- UMLS CUI [1]
- C1707811
Description
Dose modification
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
The reason for dose modification is an AE that has to be documented appropriately on the AE form.
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
Gemcitabine has to be administered on day 1 or day 8 of chemotherapy cycle.
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C0178602
Description
Dose modification
Data type
boolean
Alias
- UMLS CUI [1]
- C1707811
Description
Dose modification
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
The reason for dose modification is an AE that has to be documented appropriately on the AE form.
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
Total dose of antineoplastic agent
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C0178602
Description
Dose modification
Data type
boolean
Alias
- UMLS CUI [1]
- C1707811
Description
Dose modification
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
The reason for dose modification is an AE that has to be documented appropriately on the AE form.
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
Total dose of antineoplastic agent
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C0178602
Description
Dose modification
Data type
boolean
Alias
- UMLS CUI [1]
- C1707811
Description
Dose modification
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
The reason for dose modification is an AE that has to be documented appropriately on the AE form.
Data type
text
Alias
- UMLS CUI [1]
- C1707811
Description
Further antineoplastic treatment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C1517331
Description
Further antineoplastic treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C1517331
Description
Confirmation of correctness
Description
Name of Investigator
Data type
text
Alias
- UMLS CUI [1]
- C0008961
Description
Signature
Data type
text
Alias
- UMLS CUI [1]
- C1519316
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
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Case Report Form (HIPEC) Visit 11
- StudyEvent: ODM
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C0178602 (UMLS CUI [1,2])
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C0178602 (UMLS CUI [1,2])
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