ID

41228

Beschrijving

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 information about the Meal. It has to be filled in once for each week 1, week 2 and week 3.

Link

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

Trefwoorden

Versies (1)
  1. 20-07-20 20-07-20 - Christian Arras
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 juli 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

Meal

1 Formulieren  
  1. StudyEvent: ODM
    1. Meal
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit type
Beschrijving

Visit type

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing date/time
Beschrijving

Dosing date/time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Dosing date/time
Beschrijving

read only/not required

Datatype

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
Last Meal on Day of Dosing at Clinic
Beschrijving

Last Meal on Day of Dosing at Clinic

Alias
UMLS CUI-1
C0578574
UMLS CUI-2
C0011008
UMLS CUI-3
C0178602
UMLS CUI-4
C0442592
Predose Meal Start Date and Time
Beschrijving

Must be at least 8 hours prior to dosing.

Datatype

datetime

Alias
UMLS CUI [1,1]
C0578574
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0439565
Breakfast Meal on Day of Dosing at Clinic
Beschrijving

Breakfast Meal on Day of Dosing at Clinic

Alias
UMLS CUI-1
C2698559
UMLS CUI-2
C0439565
UMLS CUI-3
C0442592
Meal Start Date and Time
Beschrijving

Meal Beginning, Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C1998602
Meal type
Beschrijving

Meal type

Datatype

integer

Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C0332307
Indicate percent of meal consumed by patient
Beschrijving

Percent of eating a meal

Datatype

integer

Alias
UMLS CUI [1,1]
C0439165
UMLS CUI [1,2]
C3842710
Terug naar het begin van de pagina

Similar models

Meal

1 Formulieren
  1. StudyEvent: ODM
    1. Meal
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Visit type
Code List
Visit type
CL Item
Week 1 (Week 1)
CL Item
Week2 (Week 2)
CL Item
Week 3 (Week 3)
Item Group
Dosing date/time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Dosing date and time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Last Meal on Day of Dosing at Clinic
C0578574 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0442592 (UMLS CUI-4)
Last food intakte before Dosing, Date and Time
Item
Predose Meal Start Date and Time
datetime
C0578574 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Breakfast Meal on Day of Dosing at Clinic
C2698559 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0442592 (UMLS CUI-3)
Meal Beginning, Date and Time
Item
Meal Start Date and Time
datetime
C1264639 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,3])
Item
Meal type
integer
C3842710 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Meal type
Code List
Meal type
CL Item
Low-fat breakfast (12)
CL Item
High-fat breakfast (6)
Item
Indicate percent of meal consumed by patient
integer
C0439165 (UMLS CUI [1,1])
C3842710 (UMLS CUI [1,2])
Percent of eating a meal
Code List
Indicate percent of meal consumed by patient
CL Item
1 - 25% (1)
CL Item
26 - 50% (2)
CL Item
51 - 75% (3)
CL Item
76 - 100% (4)
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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