ID

16543

Beschreibung

Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Screening Visit: Pregnancy Test Identification of Painful Area NPRS 'average pain' score NPRS 'pain now' score

Link

http://clinicaltrials.gov/show/NCT01416116

Stichworte

Versionen (1)
  1. 23.07.16 23.07.16 -
Hochgeladen am

23. Juli 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Screening Visit Form 4/4 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

Englisch

Screening Visit Form 4/4 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

1 Formulare  
Pregnancy Test
Beschreibung

Pregnancy Test

Is subject female and of childbearing potential?
Beschreibung

If 'childbearing potential-NO', please provide reason of childbearing potential NO. If 'childbearing potential-YES', please provide details of pregnancy test below.

Datentyp

integer

Alias
UMLS CUI [1]
C3831118
Reason Childbearing potential - NO
Beschreibung

Childbearing potential Reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1549995
If 'Other', specify
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1]
C0205394
Select 'Not Done' if serum/urine sample was not taken.
Beschreibung

Pregnancy test done

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976
Date of Sample Taken
Beschreibung

Date of Sample Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Result serum/urine pregnancy test
Beschreibung

pregnancy test result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Identification of Painful Area
Beschreibung

Identification of Painful Area

Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Head and Neck
Beschreibung

Head and Neck

Datentyp

text

Alias
UMLS CUI [1]
C0460004
Arms
Beschreibung

Arms

Datentyp

text

Alias
UMLS CUI [1]
C1140618
Hands
Beschreibung

Hands

Datentyp

text

Alias
UMLS CUI [1]
C0018563
Torso
Beschreibung

Torso

Datentyp

text

Alias
UMLS CUI [1]
C0460005
Legs
Beschreibung

Legs

Datentyp

text

Alias
UMLS CUI [1]
C1140621
Feet
Beschreibung

Feet

Datentyp

text

Alias
UMLS CUI [1]
C0016504
Total Painful/Sensitive Area Size
Beschreibung

pain area size

Datentyp

float

Maßeinheiten
  • cm²
Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0456389
cm²
NPRS 'average pain' score
Beschreibung

NPRS 'average pain' score

Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
NPRS 'average' pain score
Beschreibung

NPRS 'average' pain score

Datentyp

integer

Alias
UMLS CUI [1]
C0582148
NPRS 'pain now' score
Beschreibung

NPRS 'pain now' score

Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
NPRS 'pain now' score
Beschreibung

NPRS 'pain now' score

Datentyp

integer

Alias
UMLS CUI [1]
C0582148
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Screening Visit Form 4/4 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Pregnancy Test
Item
Is subject female and of childbearing potential?
integer
C3831118 (UMLS CUI [1])
childbearing potential
Code List
Is subject female and of childbearing potential?
CL Item
No (0 )
CL Item
Yes (1 )
Item
Reason Childbearing potential - NO
integer
C3831118 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Childbearing potential Reason
Code List
Reason Childbearing potential - NO
CL Item
Female (2 yrs post-menopausal or surgically sterile) (1 )
CL Item
Other (99 )
Other
Item
If 'Other', specify
text
C0205394 (UMLS CUI [1])
Pregnancy test done
Item
Select 'Not Done' if serum/urine sample was not taken.
boolean
C0032976 (UMLS CUI [1])
Date of Sample Taken
Item
Date of Sample Taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result serum/urine pregnancy test
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
pregnancy test
Code List
Result serum/urine pregnancy test
CL Item
Negative (0 )
CL Item
Positive (1 )
Item Group
Identification of Painful Area
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Head and Neck
Item
Head and Neck
text
C0460004 (UMLS CUI [1])
Arms
Item
Arms
text
C1140618 (UMLS CUI [1])
Hands
Item
Hands
text
C0018563 (UMLS CUI [1])
Torso
Item
Torso
text
C0460005 (UMLS CUI [1])
Legs
Item
Legs
text
C1140621 (UMLS CUI [1])
Feet
Item
Feet
text
C0016504 (UMLS CUI [1])
pain area size
Item
Total Painful/Sensitive Area Size
float
C0030193 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Item Group
NPRS 'average pain' score
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
NPRS 'average' pain score
integer
C0582148 (UMLS CUI [1])
NPRS 'average' pain score
Code List
NPRS 'average' pain score
CL Item
0 (0 )
CL Item
1 (1 )
CL Item
2 (2 )
CL Item
3 (3 )
CL Item
4 (4 )
CL Item
5 (5 )
CL Item
6 (6 )
CL Item
7 (7 )
CL Item
8 (8 )
CL Item
9 (9 )
CL Item
10 (10 )
Item Group
NPRS 'pain now' score
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
NPRS 'pain now' score
integer
C0582148 (UMLS CUI [1])
NPRS 'pain now' score
Code List
NPRS 'pain now' score
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
0 (0)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video