ID

13575

Beschreibung

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

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Versionen (2)
  1. 17.02.16 17.02.16 -
  2. 17.02.16 17.02.16 -
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17. Februar 2016

DOI

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Adverse Events Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv

Englisch

Case Report Form (HIPEC) Adverse Events

1 Formulare  
Adverse Events Form
Beschreibung

Adverse Events Form

Patient ID
Beschreibung

Patient ID

Datentyp

integer

Alias
UMLS CUI [1]
C1269815
CRF number
Beschreibung

CRF number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0449788
Serial number of the Adverse Event
Beschreibung

Adverse Event

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Please describe the Adverse Event, using CTCAE designations
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Adverse Event Start Date
Beschreibung

Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Adverse Event End Date
Beschreibung

Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Is the Adverse Event Ongoing?
Beschreibung

Adverse Event Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826663
CTCAE Grade
Beschreibung

CTCAE Grade

Datentyp

text

Alias
UMLS CUI [1]
C1516728
Was the Adverse Event serious (SAE)?
Beschreibung

Serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Criteria for serious adverse events, please specify
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Please give the date, the adverse event turned out to be serious
Beschreibung

Serious adverse event start date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011008
Adverse Event Outcome
Beschreibung

Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Causality with trial substance
Beschreibung

Causality

Datentyp

text

Alias
UMLS CUI [1]
C1547657
Adverse event treatment
Beschreibung

Adverse event treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Please specify treatment given for this adverse event
Beschreibung

Adverse event treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
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Ähnliche Modelle

Case Report Form (HIPEC) Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Adverse Events Form
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])
Adverse Event
Item
Serial number of the Adverse Event
integer
C0877248 (UMLS CUI [1])
Adverse Event
Item
Please describe the Adverse Event, using CTCAE designations
text
C0877248 (UMLS CUI [1])
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Adverse Event Ongoing
Item
Is the Adverse Event Ongoing?
boolean
C2826663 (UMLS CUI [1])
Item
CTCAE Grade
text
C1516728 (UMLS CUI [1])
CTCAE Grade
Code List
CTCAE Grade
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
0 (0)
Serious adverse event
Item
Was the Adverse Event serious (SAE)?
boolean
C1519255 (UMLS CUI [1])
Item
Criteria for serious adverse events, please specify
text
C1519255 (UMLS CUI [1])
Serious Adverse Event
Code List
Criteria for serious adverse events, please specify
CL Item
fatal (1)
CL Item
life threatening (2)
CL Item
hospitalization/prolonged stay at hospital (3)
CL Item
permanent or severe disability (4)
CL Item
congenital abberation/birth defect (5)
Serious adverse event start date
Item
Please give the date, the adverse event turned out to be serious
date
C1519255 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event Outcome
CL Item
Recovered (1)
CL Item
Subsiding (2)
CL Item
Continuing (3)
CL Item
resolved with sequelae (4)
CL Item
increased symptoms (5)
CL Item
fatal (6)
CL Item
unknown (7)
Item
Causality with trial substance
text
C1547657 (UMLS CUI [1])
Causality
Code List
Causality with trial substance
CL Item
confirmed (1)
CL Item
probable (2)
CL Item
possible (3)
CL Item
unlikely (4)
Adverse event treatment
Item
Adverse event treatment
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Adverse event treatment
Item
Please specify treatment given for this adverse event
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
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