ID
29773
Description
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
Keywords
Versions (2)
- 4/19/18 4/19/18 - Sarah Riepenhausen
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 19, 2018
DOI
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License
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
Screen Part 1: Administrative Data and Demography
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Smoking History
Alias
- UMLS CUI-1
- C1519384
Description
Smoking behavior
Data type
text
Alias
- UMLS CUI [1]
- C0453996
Description
Converter for cigars and tobacco: 1 cigar = 7 cigarettes 1 gram (or 0.03 oz.) of tobacco = 1 cigarette
Data type
integer
Alias
- UMLS CUI [1]
- C1608325
Description
Demography for females
Alias
- UMLS CUI-1
- C0011298
- UMLS CUI-2
- C0015780
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C3831118
Description
Oral Contraceptive
Data type
boolean
Alias
- UMLS CUI [1]
- C0009905
Description
Intrauterine contraceptive device
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021900
- UMLS CUI [1,2]
- C0700589
Description
Sexual Abstinence
Data type
boolean
Alias
- UMLS CUI [1]
- C0036899
Description
Male Sterilization of Partner
Data type
boolean
Alias
- UMLS CUI [1]
- C0024559
Description
No contraceptive method
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0457083
Description
Double barrier method of contraception consisting of spermicide with either condom or diaphragm.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042241
- UMLS CUI [1,2]
- C0037862
- UMLS CUI [2,1]
- C3873750
- UMLS CUI [2,2]
- C0037862
Description
Other contraceptive methods
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Description
Details of any contraceptive drugs must be added to the CONCOMITANT MEDICATIONS page.
Data type
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C3845569
Description
Pregnancy test result
Data type
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1274040
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Screen Part 1: Administrative Data and Demography
- StudyEvent: ODM
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C0015780 (UMLS CUI-2)
C0700589 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
C0037862 (UMLS CUI [1,2])
C3873750 (UMLS CUI [2,1])
C0037862 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])