ID

44081

Descripción

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

Palabras clave

Versiones (2)
  1. 19/4/18 19/4/18 - Sarah Riepenhausen
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0
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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

Inglés

Screen Part 1: Administrative Data and Demography

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Descripción

Treatment Number

Tipo de datos

text

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

Investigator number

Tipo de datos

text

Alias
UMLS CUI [1]
C2826689
Demography
Descripción

Demography

Alias
UMLS CUI-1
C0011298
Date of assessment
Descripción

Date of assessment

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Gender

Tipo de datos

text

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

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.

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
Smoking History
Descripción

Smoking History

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

Smoking behavior

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1608325
Demography for females
Descripción

Demography for females

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

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.

Tipo de datos

text

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

Oral Contraceptive

Tipo de datos

boolean

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

Intrauterine contraceptive device

Tipo de datos

boolean

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

Sexual Abstinence

Tipo de datos

boolean

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

Male Sterilization of Partner

Tipo de datos

boolean

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

No contraceptive method

Tipo de datos

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?
Descripción

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

Tipo de datos

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?
Descripción

Other contraceptive methods

Tipo de datos

boolean

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

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

Tipo de datos

text

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

Pregnancy test result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
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Similar models

Screen Part 1: Administrative Data and Demography

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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))
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