ID
41172
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 the Lapatinib diary. This form is for dosing and meal data from the diary only. Go to visits Week 1 to Week 3 for Lapatinib and Meal data from clinic visits. This form has to be filled in for each week and each study day of the trial.
Link
https://clinicaltrials.gov/ct2/show/NCT00821054
Trefwoorden
Versies (1)
- 04-07-20 04-07-20 - Christian Arras
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 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.
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
Lapatinib diary
- StudyEvent: ODM
Beschrijving
Week number and study day
Alias
- UMLS CUI-1
- C0439230
- UMLS CUI-2
- C0449788
- UMLS CUI-3
- C2826182
Beschrijving
Week number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0449788
Beschrijving
Study day
Datatype
text
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Predose Overnight Fast
Alias
- UMLS CUI-1
- C0439565
- UMLS CUI-2
- C0015663
- UMLS CUI-3
- C0439583
Beschrijving
Study Medication - 1250 mg of lapatinib
Alias
- UMLS CUI-1
- C1506770
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0449788
Beschrijving
Date and Time of Dose
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1264639
Beschrijving
Tablet dosage form, taken, count of entities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0039225
- UMLS CUI [1,2]
- C1883727
- UMLS CUI [1,3]
- C0449788
Beschrijving
Postdose Fast
Alias
- UMLS CUI-1
- C0439568
- UMLS CUI-2
- C0015663
Beschrijving
Postdose Vomiting
Alias
- UMLS CUI-1
- C0042963
- UMLS CUI-2
- C0439568
Beschrijving
Treatment Confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Similar models
Lapatinib diary
- StudyEvent: ODM
C0449788 (UMLS CUI-2)
C2826182 (UMLS CUI-3)
C0015663 (UMLS CUI-2)
C0439583 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0178602 (UMLS CUI-2)
C0449788 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C1998602 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C1301880 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
C0439568 (UMLS CUI [1,2])
C0087111 (UMLS CUI-2)
C0566251 (UMLS CUI [1,2])
C0039225 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
C1709043 (UMLS CUI [2,3])
C0566251 (UMLS CUI [2,4])