ID

44081

Beschreibung

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Screen Part 1: Administrative Data and Demography.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Stichworte

Versionen (2)
  1. 19.04.18 19.04.18 - Sarah Riepenhausen
  2. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
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.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

Englisch

Screen Part 1: Administrative Data and Demography

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Beschreibung

Treatment Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
Investigator number
Beschreibung

Investigator number

Datentyp

text

Alias
UMLS CUI [1]
C2826689
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of assessment
Beschreibung

Date of assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race, pick one.
Beschreibung

White: Origins in the original peoples of Europe, the Middle East, Western Russia, Afghanistan, or the white racial groups of Africa. Black: Origins in any of the black racial groups of Africa. Asian: Origins in the original peoples of the Indian subcontinent, the Far East, Southeast Asia, or the Pacific islands. American Hispanic: Hispanics of North, Central, or South American origin. Other: People whose racial group is not represented above, or whose predominant origin cannot be determined.

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Smoking History
Beschreibung

Smoking History

Alias
UMLS CUI-1
C1519384
Does the subject currently smoke (includes cigarettes, cigars, tobacco)?
Beschreibung

Smoking behavior

Datentyp

text

Alias
UMLS CUI [1]
C0453996
If Yes for the item "smoking behavior", what is the number of cigarettes smoked per day?
Beschreibung

Converter for cigars and tobacco: 1 cigar = 7 cigarettes 1 gram (or 0.03 oz.) of tobacco = 1 cigarette

Datentyp

integer

Alias
UMLS CUI [1]
C1608325
Demography for females
Beschreibung

Demography for females

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0086287
Childbearing potential
Beschreibung

Use the following definitions: Premenarcheal: Females who have not begun to menstruate. Sterile: Premenopausal women who cannot conceive children. (Do not include postmenopausal women in this category.) Postmenopausal: Women who have completed menopause at least one year ago. Potentially able to conceive children: Women of childbearing age who are not sterile.

Datentyp

text

Alias
UMLS CUI [1]
C3831118
If potentially able to conceive children, is an Oral Contraceptive used?
Beschreibung

Oral Contraceptive

Datentyp

boolean

Alias
UMLS CUI [1]
C0009905
If potentially able to conceive children, is an intrauterine contraceptive device used?
Beschreibung

Intrauterine contraceptive device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021900
UMLS CUI [1,2]
C0700589
If potentially able to conceive children, is she staying abstinent?
Beschreibung

Sexual Abstinence

Datentyp

boolean

Alias
UMLS CUI [1]
C0036899
If potentially able to conceive children, is the male partner sterilized?
Beschreibung

Male Sterilization of Partner

Datentyp

boolean

Alias
UMLS CUI [1]
C0024559
If potentially able to conceive children, is no contraceptive method used?
Beschreibung

No contraceptive method

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0457083
If potentially able to conceive children, is a double barrier (condom or diaphragm) used?
Beschreibung

Double barrier method of contraception consisting of spermicide with either condom or diaphragm.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042241
UMLS CUI [1,2]
C0037862
UMLS CUI [2,1]
C3873750
UMLS CUI [2,2]
C0037862
If potentially able to conceive children, are other contraceptive methods used?
Beschreibung

Other contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205394
If other contraceptive methods are used, specify:
Beschreibung

Details of any contraceptive drugs must be added to the CONCOMITANT MEDICATIONS page.

Datentyp

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3845569
Pregnancy test result
Beschreibung

Pregnancy test result

Datentyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Screen Part 1: Administrative Data and Demography

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Investigator number
Item
Investigator number
text
C2826689 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race, pick one.
text
C0034510 (UMLS CUI [1])
Race
Code List
Race, pick one.
CL Item
White (W)
CL Item
Black (B)
CL Item
Asian (A)
CL Item
American Hispanic (H)
CL Item
other (X)
Item Group
Smoking History
C1519384 (UMLS CUI-1)
Item
Does the subject currently smoke (includes cigarettes, cigars, tobacco)?
text
C0453996 (UMLS CUI [1])
Smoking behavior
Code List
Does the subject currently smoke (includes cigarettes, cigars, tobacco)?
CL Item
Yes (Y)
CL Item
No (N)
Cigarettes smoked per day
Item
If Yes for the item "smoking behavior", what is the number of cigarettes smoked per day?
integer
C1608325 (UMLS CUI [1])
Item Group
Demography for females
C0011298 (UMLS CUI-1)
C0086287 (UMLS CUI-2)
Item
Childbearing potential
text
C3831118 (UMLS CUI [1])
Childbearing potential
Code List
Childbearing potential
CL Item
Premenarcheal (Premenarcheal)
CL Item
Sterile (of childbearing age) (Sterile (of childbearing age))
CL Item
Postmenopausal (Postmenopausal)
CL Item
Potentially able to conceive children (Potentially able to conceive children)
Oral Contraceptive
Item
If potentially able to conceive children, is an Oral Contraceptive used?
boolean
C0009905 (UMLS CUI [1])
Intrauterine contraceptive device
Item
If potentially able to conceive children, is an intrauterine contraceptive device used?
boolean
C0021900 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Sexual Abstinence
Item
If potentially able to conceive children, is she staying abstinent?
boolean
C0036899 (UMLS CUI [1])
Male Sterilization of Partner
Item
If potentially able to conceive children, is the male partner sterilized?
boolean
C0024559 (UMLS CUI [1])
No contraceptive method
Item
If potentially able to conceive children, is no contraceptive method used?
boolean
C0700589 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Double Barrier (Condom, Diaphragm)
Item
If potentially able to conceive children, is a double barrier (condom or diaphragm) used?
boolean
C0042241 (UMLS CUI [1,1])
C0037862 (UMLS CUI [1,2])
C3873750 (UMLS CUI [2,1])
C0037862 (UMLS CUI [2,2])
Other contraceptive methods
Item
If potentially able to conceive children, are other contraceptive methods used?
boolean
C0700589 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other contraceptive methods
Item
If other contraceptive methods are used, specify:
text
C0700589 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item
Pregnancy test result
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy test result
Code List
Pregnancy test result
CL Item
positive (positive)
CL Item
negative (negative)
CL Item
not applicable (not of childbearing potential) (not applicable (not of childbearing potential))
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