ID

41226

Beschreibung

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 Local Laboratory for clinical chemistry and haematology which have to be filled in once for Screening, Day-1, Week 1-3, the Follow-up visit and as often as necessary in logs and 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.

Link

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

Stichworte

Versionen (1)
  1. 20.07.20 20.07.20 - Christian Arras
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Juli 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

Englisch

Local Laboratory

1 Formulare  
  1. StudyEvent: ODM
    1. Local Laboratory
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit type
Beschreibung

Visit type

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Clinical Chemistry
Beschreibung

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Laboratory ID
Beschreibung

not required/read only

Datentyp

integer

Alias
UMLS CUI [1]
C2986056
Laboratory name and address
Beschreibung

Not applicable for Screening Visit.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C1442065
UMLS CUI [1,3]
C0022877
Laboratory name
Beschreibung

After once filled in at Screening visit, only to be filled in if Laboratory name has changed.

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Address
Beschreibung

After once filled in at Screening visit, only to be filled in if Laboratory name has changed.

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
Clinical Chemistry Analytes
Beschreibung

Please answer the following questions for each Clinical Chemistry Analytes.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0022885
Clinical Chemistry, type of result
Beschreibung

Type of result, Clinical Chemistry

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
If Numeric Result, value:
Beschreibung

If Numeric Result, value:

Datentyp

text

Alias
UMLS CUI [1]
C2347373
If Character Result, value:
Beschreibung

If Character Result, value:

Datentyp

text

Alias
UMLS CUI [1]
C2350015
Haematology
Beschreibung

Haematology

Alias
UMLS CUI-1
C0018941
Laboratory ID
Beschreibung

not required/read only

Datentyp

integer

Alias
UMLS CUI [1]
C2986056
Laboratory name and address
Beschreibung

Not applicable for Screening Visit.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C1442065
UMLS CUI [1,3]
C0022877
Laboratory name
Beschreibung

After once filled in at Screening visit, only to be filled in if Laboratory name has changed.

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Address
Beschreibung

After once filled in at Screening visit, only to be filled in if Laboratory name has changed.

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
Haematology Analytes
Beschreibung

Please answer the following questions for each Haematology Analytes.

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Haematology, type of result
Beschreibung

Type of result, Haematology finding

Datentyp

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
If Numeric Result, value:
Beschreibung

If Numeric Result, value:

Datentyp

text

Alias
UMLS CUI [1]
C2347373
If Character Result, value:
Beschreibung

If Character Result, value:

Datentyp

text

Alias
UMLS CUI [1]
C2350015
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Ähnliche Modelle

Local Laboratory

1 Formulare
  1. StudyEvent: ODM
    1. Local Laboratory
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Screen (Screen)
CL Item
Day-1 (Day-1)
CL Item
Week 1 (Week 1)
CL Item
Week 2 (Week 2)
CL Item
Week 3 (Week 3)
CL Item
F/U (F/U)
CL Item
Logs/Repeats (Logs/Rpts)
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Laboratory ID
Item
Laboratory ID
integer
C2986056 (UMLS CUI [1])
Item
Laboratory name and address
integer
C3258037 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
Laboratory name and address
Code List
Laboratory name and address
CL Item
Results from the same lab as in the previous visit (98)
CL Item
If not, please provide: (99)
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Laboratory address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Date and time sample taken
Item
Date and time sample taken
partialDatetime
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Item
Clinical Chemistry Analytes
integer
C0008000 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Clinical Chemistry Analytes
Code List
Clinical Chemistry Analytes
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Carbon Dioxide (4)
CL Item
Urea (5)
CL Item
Creatinine (6)
CL Item
Calcium (7)
CL Item
Albumin (8)
CL Item
Total Bilirubin (9)
CL Item
Direct Bilirubin (10)
CL Item
Alkaline Phosphatase (11)
CL Item
AST (12)
CL Item
ALT (13)
Item
Clinical Chemistry, type of result
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Clinical Chemistry, type of result
CL Item
Numeric result (97)
CL Item
Character result (98)
CL Item
No result (99)
If Numeric Result, value:
Item
If Numeric Result, value:
text
C2347373 (UMLS CUI [1])
If Character Result, value:
Item
If Character Result, value:
text
C2350015 (UMLS CUI [1])
Item Group
Haematology
C0018941 (UMLS CUI-1)
Laboratory ID
Item
Laboratory ID
integer
C2986056 (UMLS CUI [1])
Item
Laboratory name and address
integer
C3258037 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
Laboratory name and address
Code List
Laboratory name and address
CL Item
Results from the same lab as in the previous visit (98)
CL Item
If not, please provide: (99)
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Laboratory address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Date and time sample taken
Item
Date and time sample taken
partialDatetime
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Item
Haematology Analytes
integer
C0018941 (UMLS CUI [1])
Clinical Chemistry Analytes
Code List
Haematology Analytes
CL Item
Haemoglobin (1)
CL Item
RBC (2)
CL Item
Platelets (3)
CL Item
WBC (4)
CL Item
Neutrophils (absolute) (5)
CL Item
Lymphocytes (absolute) (6)
CL Item
Monocytes (absolute) (7)
CL Item
Eosinophils (absolute) (8)
CL Item
Basophils (absolute) (9)
CL Item
INR (10)
Item
Haematology, type of result
integer
C0474523 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Haematology, type of result
CL Item
Numeric result (97)
CL Item
Character result (98)
CL Item
No result (99)
If Numeric Result, value:
Item
If Numeric Result, value:
text
C2347373 (UMLS CUI [1])
If Character Result, value:
Item
If Character Result, value:
text
C2350015 (UMLS CUI [1])
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