ID

39887

Descripción

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the pulmonary function test. It has to be filled in for screening, V2b, V3, V5, follow-up and if required for logs/ repeats.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Palabras clave

Versiones (2)
  1. 24/2/20 24/2/20 -
  2. 28/2/20 28/2/20 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

28 de febrero de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

Inglés

Pulmonary function test

1 formularios  
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Visit type
Descripción

Please note for which visit you will fill in this document.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Pulmonary function test
Descripción

Pulmonary function test

Alias
UMLS CUI-1
C0024119
Date of test
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C2826247
Time of test
Descripción

00:00-23:59

Tipo de datos

time

Alias
UMLS CUI [1]
C0429928
Bronchodilator
Descripción

For V2b fill in for both, pre- and post-bronchodilator. For V3, V5 and follow-up only fill in for pre-bronchodilator. This item has not to be filled in for screening and follow-up.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0006280
Test type
Descripción

Pulmonary Function Test type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0332307
Reading number
Descripción

Please fill in three readings for both test types as well as for pre- and postbronchodilator.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0456984
Test result
Descripción

Pulmonary Function Test result

Tipo de datos

float

Unidades de medida
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
L
Test not done
Descripción

Only to fill in for logs/ repeats.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1272696
UMLS CUI [1,2]
C0024119
Volver a la parte superior de la página

Similar models

Pulmonary function test

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
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
V2b (2)
CL Item
V3 (3)
CL Item
V5 (4)
CL Item
Follow-up (5)
CL Item
Logs/ Repeats (6)
Item Group
Pulmonary function test
C0024119 (UMLS CUI-1)
Date of test
Item
Date of test
date
C2826247 (UMLS CUI [1])
Time of test
Item
Time of test
time
C0429928 (UMLS CUI [1])
Item
Bronchodilator
integer
C0006280 (UMLS CUI [1])
Bronchodilator
Code List
Bronchodilator
CL Item
Pre-Bronchodilator (1)
CL Item
Post-Bronchodilator (2)
Item
Test type
integer
C0024119 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Test type
Code List
Test type
CL Item
FEV1 (1)
CL Item
FVC (2)
Item
Reading number
integer
C0024119 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
Reading number
Code List
Reading number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Pulmonary Function Test result
Item
Test result
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Pulmonary Function Test not done
Item
Test not done
boolean
C1272696 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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