ID
36169
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)
- 22.04.19 22.04.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
22. April 2019
DOI
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Lizenz
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
Study Conclusion
- StudyEvent: ODM
Beschreibung
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event, Numbers
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschreibung
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschreibung
Status of Treatment Blind
Alias
- UMLS CUI-1
- C2347038
- UMLS CUI-2
- C0449438
Beschreibung
Subject Unblinding Event Record
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3897431
Beschreibung
Subject Unblinding Event Record, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschreibung
Subject Unblinding Event Record, Reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Beschreibung
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Withdrawal
Alias
- UMLS CUI-1
- C2349954
Beschreibung
Withdraw
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beschreibung
Withdraw, Reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0566251
Beschreibung
Withdraw, Decision
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0679006
Beschreibung
Withdraw Date last contact
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Beschreibung
Withdraw, Date last contact, General physical condition
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Beschreibung
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator Signature, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Investigator Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Cervical Colposcopy Diagram
Alias
- UMLS CUI-1
- C0009417
- UMLS CUI-2
- C0681494
Beschreibung
L Leukoplakia W White Epithelium P Punctation M Mosaic V Atypical Vessels C Condyloma Po Polyp E Erosion/ Ulceration X Biopsy Sites I Invasive Carcinoma
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0009417
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0450429
- UMLS CUI [1,4]
- C0332307
Beschreibung
Use of Human Samples by GSK
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0457083
Beschreibung
Laboratory Procedures, Usage
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0457083
Beschreibung
Laboratory Procedures, Storage, Duration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C0449238
Beschreibung
Date in time, Consent Forms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Beschreibung
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Investigator Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator Signature, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Investigator Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Reason for Non-Participation
Alias
- UMLS CUI-1
- C0558080
- UMLS CUI-2
- C0679823
- UMLS CUI-3
- C0392360
Beschreibung
Clinical Trial Subject Unique Identifier, Previous
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0205156
Beschreibung
Patient date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Unwilling, participation, Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Beschreibung
Unwilling, participation, Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Beschreibung
Date last contact
Datentyp
date
Alias
- UMLS CUI [1]
- C0805839
Ähnliche Modelle
Study Conclusion
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0449438 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0681494 (UMLS CUI-2)
C0221198 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
C0457083 (UMLS CUI-2)
C0457083 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0009797 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C0205156 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])