ID

36173

Beschreibung

Study ID: 109616 (Y7) Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Stichworte

Versionen (1)
  1. 22.04.19 22.04.19 -
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GlaxoSmithKline

Hochgeladen am

22. April 2019

DOI

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Creative Commons BY-NC 3.0
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Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

Englisch

Questionnaire

1 Formulare  
  1. StudyEvent: ODM
    1. Questionnaire
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Are you currently a smoker?
Beschreibung

Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
If Yes, how many cigarettes on average do you smoke?
Beschreibung

number of cigarettes per day

Datentyp

integer

Maßeinheiten
  • per day
Alias
UMLS CUI [1]
C3694146
per day
If Yes, how many cigarettes on average do you smoke?
Beschreibung

Smoker -amount smoked

Datentyp

integer

Maßeinheiten
  • per week
Alias
UMLS CUI [1]
C1608325
per week
Did your smoking habits (smoker/non-smoker) have changed since the completion of the last questionnaire?
Beschreibung

Tobacco use, Changing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0392747
If Yes, indicate when
Beschreibung

Tobacco use, Changing, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0011008
Sexual History
Beschreibung

Sexual History

Alias
UMLS CUI-1
C0036864
Since you completed the previous questionnaire, how often on average did you have sexual intercourse or genital-to-genital sexual contact?
Beschreibung

Please give your answer in number of times per week or month, whichever is easiest

Datentyp

text

Alias
UMLS CUI [1,1]
C0036864
UMLS CUI [1,2]
C0449788
Since you completed the previous questionnaire, with how many partners have you had sexual intercourse or genital-to-genital sexual contact?
Beschreibung

Sex behavior, Sexual Partners, Count of entities

Datentyp

integer

Alias
UMLS CUI [1,1]
C0036864
UMLS CUI [1,2]
C0036911
UMLS CUI [1,3]
C0449788
How many of these partners were NEW partners?
Beschreibung

“NEW” means a partner with whom you have never had sexual intercourse or genital-to-genital sexual contact before completion of the previous questionnaire.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0036864
UMLS CUI [1,2]
C0036911
UMLS CUI [1,3]
C0205314
UMLS CUI [1,4]
C0449788
Contraceptive History
Beschreibung

Contraceptive History

Alias
UMLS CUI-1
C0700589
Oral contraceptive (birth control pill)
Beschreibung

Contraceptives, oral

Datentyp

text

Alias
UMLS CUI [1]
C0009905
Depo-Provera
Beschreibung

Depo-provera or injectables (shots)

Datentyp

text

Alias
UMLS CUI [1]
C3842800
Lunelle
Beschreibung

Lunelle - a once-a-month injection

Datentyp

text

Alias
UMLS CUI [1]
C3842792
Hormonal patch
Beschreibung

Contraceptive patch

Datentyp

text

Alias
UMLS CUI [1]
C2985284
Vaginal contraceptive ring
Beschreibung

Vaginal Ring

Datentyp

text

Alias
UMLS CUI [1]
C0042260
Hormonal coated intrauterine device
Beschreibung

Intrauterine Devices

Datentyp

text

Alias
UMLS CUI [1]
C0021900
Male or female condom (rubber)
Beschreibung

Condom Use

Datentyp

text

Alias
UMLS CUI [1]
C0679782
Other hormonal contraceptive methods (E. g.: IUD Cu -T380 or multiload; monthly injectable hormonal contraceptives - Mesigyna, Perlutan; etc.), please specify
Beschreibung

Contraceptive methods, Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205394
Other Gynecological History
Beschreibung

Other Gynecological History

Alias
UMLS CUI-1
C0474455
UMLS CUI-2
C0205394
Since you completed the previous questionna ire, did your health care provider tell you that you had one of the following conditions? - Venereal/genital warts, condyloma
Beschreibung

Viral Warts, Genitals; Genital Condyloma

Datentyp

text

Alias
UMLS CUI [1,1]
C0343642
UMLS CUI [1,2]
C0017420
UMLS CUI [2]
C0744357
Since you completed the previous questionnaire, did your health care provider tell you that you had one of the following conditions? - Genital herpes
Beschreibung

Genital Herpes

Datentyp

text

Alias
UMLS CUI [1]
C0019342
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Ähnliche Modelle

Questionnaire

1 Formulare
  1. StudyEvent: ODM
    1. Questionnaire
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
General Information
C1508263 (UMLS CUI-1)
Tobacco use
Item
Are you currently a smoker?
boolean
C0543414 (UMLS CUI [1])
number of cigarettes per day
Item
If Yes, how many cigarettes on average do you smoke?
integer
C3694146 (UMLS CUI [1])
Smoker -amount smoked
Item
If Yes, how many cigarettes on average do you smoke?
integer
C1608325 (UMLS CUI [1])
Tobacco use, Changing
Item
Did your smoking habits (smoker/non-smoker) have changed since the completion of the last questionnaire?
boolean
C0543414 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Tobacco use, Changing, Date in time
Item
If Yes, indicate when
date
C0543414 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Sexual History
C0036864 (UMLS CUI-1)
Sexual Intercourse, Count of entities
Item
Since you completed the previous questionnaire, how often on average did you have sexual intercourse or genital-to-genital sexual contact?
text
C0036864 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Sex behavior, Sexual Partners, Count of entities
Item
Since you completed the previous questionnaire, with how many partners have you had sexual intercourse or genital-to-genital sexual contact?
integer
C0036864 (UMLS CUI [1,1])
C0036911 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Sex behavior, Sexual Partners, New, Count of entities
Item
How many of these partners were NEW partners?
integer
C0036864 (UMLS CUI [1,1])
C0036911 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,4])
Item Group
Contraceptive History
C0700589 (UMLS CUI-1)
Item
Oral contraceptive (birth control pill)
text
C0009905 (UMLS CUI [1])
Lunelle - a once-a-month injection
Code List
Oral contraceptive (birth control pill)
CL Item
Regularly (1)
CL Item
Sometimes (2)
CL Item
Never (3)
Item
Depo-Provera
text
C3842800 (UMLS CUI [1])
Lunelle - a once-a-month injection
Code List
Depo-Provera
CL Item
Regularly (1)
CL Item
Sometimes (2)
CL Item
Never (3)
Item
Lunelle
text
C3842792 (UMLS CUI [1])
Lunelle - a once-a-month injection
Code List
Lunelle
CL Item
Regularly (1)
CL Item
Sometimes (2)
CL Item
Never (3)
Item
Hormonal patch
text
C2985284 (UMLS CUI [1])
Lunelle - a once-a-month injection
Code List
Hormonal patch
CL Item
Regularly (1)
CL Item
Sometimes (2)
CL Item
Never (3)
Item
Vaginal contraceptive ring
text
C0042260 (UMLS CUI [1])
Lunelle - a once-a-month injection
Code List
Vaginal contraceptive ring
CL Item
Regularly (1)
CL Item
Sometimes (2)
CL Item
Never (3)
Item
Hormonal coated intrauterine device
text
C0021900 (UMLS CUI [1])
Lunelle - a once-a-month injection
Code List
Hormonal coated intrauterine device
CL Item
Yes (1)
CL Item
Never (2)
Item
Male or female condom (rubber)
text
C0679782 (UMLS CUI [1])
Condom Use
Code List
Male or female condom (rubber)
CL Item
Regularly (1)
CL Item
Sometimes (2)
CL Item
Never (3)
Item
Other hormonal contraceptive methods (E. g.: IUD Cu -T380 or multiload; monthly injectable hormonal contraceptives - Mesigyna, Perlutan; etc.), please specify
text
C0700589 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Condom Use
Code List
Other hormonal contraceptive methods (E. g.: IUD Cu -T380 or multiload; monthly injectable hormonal contraceptives - Mesigyna, Perlutan; etc.), please specify
CL Item
Regularly (1)
CL Item
Sometimes (2)
CL Item
Never (3)
Item Group
Other Gynecological History
C0474455 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Since you completed the previous questionna ire, did your health care provider tell you that you had one of the following conditions? - Venereal/genital warts, condyloma
text
C0343642 (UMLS CUI [1,1])
C0017420 (UMLS CUI [1,2])
C0744357 (UMLS CUI [2])
Viral Warts, Genitals; Genital Condyloma
Code List
Since you completed the previous questionna ire, did your health care provider tell you that you had one of the following conditions? - Venereal/genital warts, condyloma
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Since you completed the previous questionnaire, did your health care provider tell you that you had one of the following conditions? - Genital herpes
text
C0019342 (UMLS CUI [1])
Viral Warts, Genitals; Genital Condyloma
Code List
Since you completed the previous questionnaire, did your health care provider tell you that you had one of the following conditions? - Genital herpes
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
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