ID

36177

Descrizione

Study ID: 109616 (Y7), 109624 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

Keywords

versioni (1)
  1. 22/04/19 22/04/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

22 aprile 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

Inglese

Non-Serious Adverse Events

1 moduli  
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrizione

Clinical Trial Subject Unique Identifier

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Descrizione

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any of the following non-serious adverse events been occurred during the study period? - New onset of chronic diseases - Conditions prompting emergency room visits not related to common diseases - Conditions prompting physician visits not related to common diseases
Descrizione

Non-serious Adverse Event

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1518404
AE No.
Descrizione

Non-serious Adverse Event, Numbers

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Descrizione

Non-serious Adverse Event, Description

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Please check box in case of new onset of chronic diseases
Descrizione

Non-serious Adverse Event, Chronic disease, New Onset

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C0449244
Date Started
Descrizione

Non-serious Adverse Event, Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Date Stopped
Descrizione

Non-serious Adverse Event, End Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Maximum Intensity
Descrizione

Non-serious Adverse Event, Severity of Adverse Event

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrizione

Non-serious Adverse Event, Relationship, Experimental drug

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Outcome
Descrizione

Non-serious Adverse Event, Adverse Event Outcome

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Medically attended visit
Descrizione

Non-serious Adverse Event, Visit, Advice, Medical

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel
Descrizione

Non-serious Adverse Event, Visit, Advice, Medical, Type

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307
Ritorna all'inizio della pagina

Similar models

Non-Serious Adverse Events

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Has any of the following non-serious adverse events been occurred during the study period? - New onset of chronic diseases - Conditions prompting emergency room visits not related to common diseases - Conditions prompting physician visits not related to common diseases
boolean
C1518404 (UMLS CUI [1])
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious Adverse Event, Numbers
Code List
AE No.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Non-serious Adverse Event, Description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Non-serious Adverse Event, Chronic disease, New Onset
Item
Please check box in case of new onset of chronic diseases
boolean
C1518404 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Non-serious Adverse Event, Start Date
Item
Date Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Event, End Date
Item
Date Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Non-serious Adverse Event, Severity of Adverse Event
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Non-serious Adverse Event, Relationship, Experimental drug
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Severity of Adverse Event
Code List
Outcome
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Non-serious Adverse Event, Visit, Advice, Medical
Item
Medically attended visit
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Non-serious Adverse Event, Visit, Advice, Medical, Type
Item
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel
text
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial