ID

32973

Descripción

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form for Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry. It has to be filled in for screening (only compliance restrictions), period 1-5 and for follow-up.

Palabras clave

Versiones (2)
  1. 22/11/18 22/11/18 -
  2. 23/11/18 23/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

Sin comentarios

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

Inglés

Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

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
Screening, Treatment Period Number, Follow up
Descripción

Screening, Treatment Period Number, Follow up

Tipo de datos

text

Alias
UMLS CUI [1]
C0220908
UMLS CUI [2,1]
C0237753
UMLS CUI [2,2]
C1948053
UMLS CUI [3]
C1522577
Compliance Restrictions
Descripción

Compliance Restrictions

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C2065135
Date of Assessment
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
Descripción

Requirements compliance

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C2065135
Is the subject aware of any forthcoming requirements?
Descripción

Aware of forthcoming requirements

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Comments to compliance
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1321605
Concomitant Medications and Adverse Event Enquiry
Descripción

Concomitant Medications and Adverse Event Enquiry

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1519255
Has the subject used any concomitant medications?
Descripción

If YES, record on CONCOMITANT MED/CATIONS page(s).

Tipo de datos

text

Alias
UMLS CUI [1]
C2347852
Has there been any change in the state of the subject's health?
Descripción

If YES record any adverse events as per protocol.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0392747
Volver a la parte superior de la página

Similar models

Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

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])
Item
Screening, Treatment Period Number, Follow up
text
C0220908 (UMLS CUI [1])
C0237753 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1522577 (UMLS CUI [3])
Period Number
Code List
Screening, Treatment Period Number, Follow up
CL Item
Screening (1)
CL Item
Treatment Period 1 (2)
CL Item
Treatment Period 2 (3)
CL Item
Treatment Period 3 (4)
CL Item
Treatment Period 4 (5)
CL Item
Follow-up (FU)
CL Item
Treatment Period 5 (6)
Item Group
Compliance Restrictions
C1321605 (UMLS CUI-1)
C2065135 (UMLS CUI-2)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
text
C0525058 (UMLS CUI [1,1])
C2065135 (UMLS CUI [1,2])
Requirements compliance
Code List
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is the subject aware of any forthcoming requirements?
text
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Aware of forthcoming requirements
Code List
Is the subject aware of any forthcoming requirements?
CL Item
Yes (Y)
CL Item
No (N)
Comments
Item
Comments to compliance
text
C0947611 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item Group
Concomitant Medications and Adverse Event Enquiry
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Has the subject used any concomitant medications?
text
C2347852 (UMLS CUI [1])
Concomitant medications
Code List
Has the subject used any concomitant medications?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has there been any change in the state of the subject's health?
text
C0018759 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Health state, change
Code List
Has there been any change in the state of the subject's health?
CL Item
Yes (Y)
CL Item
No (N)
Volver a la parte superior de la página 

Ayuda

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