ID

17708

Description

Study documentation part: Enoxaparin administration measures for the intervention group, VTETumor02. This is a prospective, randomized, controlled, unicentric, open study on prophylactic treatment of thromboembolism with Enoxaparin in non-surgical oncology patients under systemic antineoplastic therapy. Principal Investigator Prof. Dr. Max E. Scheulen, Clinic and Polyclinic for Internal medicine (Tumor research), University Hospital of Essen, Germany. EudraCT number: 2007-002036-28, Version 0.6 vom 06.08.09.

Keywords

Versions (1)
  1. 9/28/16 9/28/16 -
Uploaded on

September 28, 2016

DOI

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License

Creative Commons BY-NC 3.0
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End form: Enoxaparin administration measures for the intervention group VTETumor02 Prophylactic Treatment of Thromboembolism with Enoxaparin EudraCT number: 2007-002036-28

German

Enoxaparin administration measures for the intervention group

1 forms  
Enoxaparin-Gabe Maßnahmen
Description

Enoxaparin-Gabe Maßnahmen

Alias
UMLS CUI-1
C3469597
UMLS CUI-2
C0206460
Patienten-Nr.:
Description

Patient ID

Data type

integer

Alias
UMLS CUI [1]
C1269815
Baseline Ausgabe von 1 Karton mit 90 Spritzen am
Description

date Supply

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1561604
Weitere Ausgaben am 2:
Description

date Supply

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1561604
Weitere Ausgaben am 3:
Description

date Supply

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1561604
Weitere Ausgaben am 4:
Description

date Supply

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1561604
Telefonkontrolle ca. 1 Woche nach der Entlassung am
Description

date follow up telephone

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1522577
UMLS CUI [1,3]
C0039457
Schwierigkeiten
Description

Complication

Data type

boolean

Alias
UMLS CUI [1]
C0009566
Falls ja, welche
Description

Complication

Data type

text

Alias
UMLS CUI [1]
C0009566
Visite T1. nach 3/4 Wochen Anzahl Spritzen
Description

number of Injections

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
Visite T1. nach 3/4 Wochen Anzahl Spritzen (verbliebener)
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
ausreichend compliant
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Bemerkungen
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Visite T2. nach 6/8 Wochen Anzahl Spritzen
Description

number of Injections

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
Visite T2. nach 6/8 Wochen Anzahl Spritzen (verbliebener)
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
ausreichend compliant
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Bemerkungen
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Visite T3. nach 9/12 Wochen Anzahl Spritzen
Description

number of Injections

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
Visite T3. nach 9/12 Wochen Anzahl Spritzen (verbliebener)
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
ausreichend compliant
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Bemerkungen
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Visite T4. nach 12/16 Wochen Anzahl Spritzen
Description

number of Injections

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
Visite T4. nach 12/16 Wochen Anzahl Spritzen (verbliebener)
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
ausreichend compliant
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Bemerkungen
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Visite T5. nach 15/20 Wochen Anzahl Spritzen
Description

number of Injections

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
Visite T5. nach 15/20 Wochen Anzahl Spritzen (verbliebener)
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
ausreichend compliant
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Bemerkungen
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Visite T6. nach 18/24 Wochen Anzahl Spritzen
Description

number of Injections

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
Visite T6. nach 18/24 Wochen Anzahl Spritzen (verbliebener)
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
ausreichend compliant
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Bemerkungen
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Visite T7. nach 21 Wochen Anzahl Spritzen
Description

number of Injections

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
Visite T7. nach 21 Wochen Anzahl Spritzen (verbliebener)
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
ausreichend compliant
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Bemerkungen
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Visite T8. nach 24 Wochen Anzahl Spritzen
Description

number of Injections

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
Visite T8. nach 24 Wochen Anzahl Spritzen (verbliebener)
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
ausreichend compliant
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Bemerkungen
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Endkontrolle am:
Description

date follow up last

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1522577
UMLS CUI [1,3]
C1517741
Anzahl der vorhandenen Packungen:
Description

number of Injections Present

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C0150312
Anzahl verbliebener Spritzen:
Description

number of Injections Remaining

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C1527428
Therapiepause wegen Thromobozytenwerten < 50.000µl bei Pat. des Therapiearms
Description

Therapiepause wegen Thromobozytenwerten < 50.000µl bei Pat. des Therapiearms

Alias
UMLS CUI-1
C1710384
Therapiepause von:
Description

start date therapy interrupted

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1710384
Therapiepause bis :
Description

end date Therapy interrupted

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1710384
Therapiepause wegen:
Description

Reason for Treatment Interruption

Data type

text

Alias
UMLS CUI [1]
C3538832
Therapieabbruch mit Heparin:
Description

Therapy cessation heparin

Data type

boolean

Alias
UMLS CUI [1,1]
C1699848
UMLS CUI [1,2]
C0019134
Therapieabbruch mit Heparin am:
Description

date Therapy cessation heparin

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1699848
UMLS CUI [1,3]
C0019134
Therapieabbruch mit Heparin wegen:
Description

reason Therapy cessation heparin

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1699848
UMLS CUI [1,3]
C0019134
Verordnung von Heparin bei Patienten des Nullarms
Description

Verordnung von Heparin bei Patienten des Nullarms

Alias
UMLS CUI-1
C0033080
UMLS CUI-2
C0019134
Verordnung von Heparin von:
Description

start date prescription Heparin

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C0019134
Verordnung von Heparin bis :
Description

end date prescription Heparin

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C0019134
Verordnung von Heparin wegen:
Description

reason prescription Heparin

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C0019134
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Similar models

Enoxaparin administration measures for the intervention group

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Enoxaparin-Gabe Maßnahmen
C3469597 (UMLS CUI-1)
C0206460 (UMLS CUI-2)
Patient ID
Item
Patienten-Nr.:
integer
C1269815 (UMLS CUI [1])
date Supply
Item
Baseline Ausgabe von 1 Karton mit 90 Spritzen am
date
C0011008 (UMLS CUI [1,1])
C1561604 (UMLS CUI [1,2])
date Supply
Item
Weitere Ausgaben am 2:
date
C0011008 (UMLS CUI [1,1])
C1561604 (UMLS CUI [1,2])
date Supply
Item
Weitere Ausgaben am 3:
date
C0011008 (UMLS CUI [1,1])
C1561604 (UMLS CUI [1,2])
date Supply
Item
Weitere Ausgaben am 4:
date
C0011008 (UMLS CUI [1,1])
C1561604 (UMLS CUI [1,2])
date follow up telephone
Item
Telefonkontrolle ca. 1 Woche nach der Entlassung am
date
C0011008 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
Complication
Item
Schwierigkeiten
boolean
C0009566 (UMLS CUI [1])
Complication
Item
Falls ja, welche
text
C0009566 (UMLS CUI [1])
number of Injections
Item
Visite T1. nach 3/4 Wochen Anzahl Spritzen
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
number of Injections Remaining
Item
Visite T1. nach 3/4 Wochen Anzahl Spritzen (verbliebener)
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
compliance
Item
ausreichend compliant
boolean
C1321605 (UMLS CUI [1])
comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
number of Injections
Item
Visite T2. nach 6/8 Wochen Anzahl Spritzen
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
number of Injections Remaining
Item
Visite T2. nach 6/8 Wochen Anzahl Spritzen (verbliebener)
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
compliance
Item
ausreichend compliant
boolean
C1321605 (UMLS CUI [1])
comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
number of Injections
Item
Visite T3. nach 9/12 Wochen Anzahl Spritzen
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
number of Injections Remaining
Item
Visite T3. nach 9/12 Wochen Anzahl Spritzen (verbliebener)
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
compliance
Item
ausreichend compliant
boolean
C1321605 (UMLS CUI [1])
comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
number of Injections
Item
Visite T4. nach 12/16 Wochen Anzahl Spritzen
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
number of Injections Remaining
Item
Visite T4. nach 12/16 Wochen Anzahl Spritzen (verbliebener)
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
compliance
Item
ausreichend compliant
boolean
C1321605 (UMLS CUI [1])
comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
number of Injections
Item
Visite T5. nach 15/20 Wochen Anzahl Spritzen
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
number of Injections Remaining
Item
Visite T5. nach 15/20 Wochen Anzahl Spritzen (verbliebener)
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
compliance
Item
ausreichend compliant
boolean
C1321605 (UMLS CUI [1])
comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
number of Injections
Item
Visite T6. nach 18/24 Wochen Anzahl Spritzen
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
number of Injections Remaining
Item
Visite T6. nach 18/24 Wochen Anzahl Spritzen (verbliebener)
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
compliance
Item
ausreichend compliant
boolean
C1321605 (UMLS CUI [1])
comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
number of Injections
Item
Visite T7. nach 21 Wochen Anzahl Spritzen
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
number of Injections Remaining
Item
Visite T7. nach 21 Wochen Anzahl Spritzen (verbliebener)
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
compliance
Item
ausreichend compliant
boolean
C1321605 (UMLS CUI [1])
comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
number of Injections
Item
Visite T8. nach 24 Wochen Anzahl Spritzen
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
number of Injections Remaining
Item
Visite T8. nach 24 Wochen Anzahl Spritzen (verbliebener)
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
compliance
Item
ausreichend compliant
boolean
C1321605 (UMLS CUI [1])
comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
date follow up last
Item
Endkontrolle am:
date
C0011008 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
number of Injections Present
Item
Anzahl der vorhandenen Packungen:
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
number of Injections Remaining
Item
Anzahl verbliebener Spritzen:
integer
C0449788 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
Item Group
Therapiepause wegen Thromobozytenwerten < 50.000µl bei Pat. des Therapiearms
C1710384 (UMLS CUI-1)
start date therapy interrupted
Item
Therapiepause von:
date
C0808070 (UMLS CUI [1,1])
C1710384 (UMLS CUI [1,2])
end date Therapy interrupted
Item
Therapiepause bis :
date
C0806020 (UMLS CUI [1,1])
C1710384 (UMLS CUI [1,2])
Reason for Treatment Interruption
Item
Therapiepause wegen:
text
C3538832 (UMLS CUI [1])
Therapy cessation heparin
Item
Therapieabbruch mit Heparin:
boolean
C1699848 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
date Therapy cessation heparin
Item
Therapieabbruch mit Heparin am:
date
C0011008 (UMLS CUI [1,1])
C1699848 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
reason Therapy cessation heparin
Item
Therapieabbruch mit Heparin wegen:
text
C0392360 (UMLS CUI [1,1])
C1699848 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
Item Group
Verordnung von Heparin bei Patienten des Nullarms
C0033080 (UMLS CUI-1)
C0019134 (UMLS CUI-2)
start date prescription Heparin
Item
Verordnung von Heparin von:
date
C0808070 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
end date prescription Heparin
Item
Verordnung von Heparin bis :
date
C0806020 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
reason prescription Heparin
Item
Verordnung von Heparin wegen:
text
C0392360 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
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