ID

40268

Descripción

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the survey of the vital signs once at the screening, study visit at day-1, weeks 1-3 and the follow-up visit and if required as often as needed for logs/repeats. Week 3 assessments can be used as Follow-up assessments for subjects who have completed the 24 hour PK blood draw at the Week 3 visit and are proceeding into the continuing study EGF111767. If this applies, do NOT reenter the same data twice; leave a form comment instead.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Palabras clave

  1. 26/3/20 26/3/20 - Christian Arras
  2. 26/3/20 26/3/20 - Christian Arras
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de marzo 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.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

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

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit type
Descripción

Visit type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual Date
Descripción

Date in time

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Time relative to dosing
Descripción

only to be filled in at Visits Week 1 to 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
Height
Descripción

only to be filled in at screening visit

Tipo de datos

float

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

only to be filled in at screening visit

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Descripción

Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Screen (Screen)
CL Item
Day-1 (Day-1)
CL Item
F/U (F/U)
CL Item
Week 1 (Week 1)
CL Item
Week2 (Week 2)
CL Item
Week 3 (Week 3)
CL Item
Logs/Repeats (Logs/Rpts)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date in time
Item
Actual Date
date
C0011008 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Code List
Time relative to dosing
CL Item
Predose (1)
CL Item
0.5 Hr post dose (2)
CL Item
1 Hr post dose (3)
CL Item
4 Hrs post dose (4)
CL Item
24 hrs post dose (5)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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