ID

29423

Beschrijving

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Concomitant Medications

Trefwoorden

  1. 22-03-18 22-03-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 maart 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587

Concomitant Medications

Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beschrijving

Drug Name

Datatype

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Dose
Beschrijving

Dose

Datatype

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
Unit
Beschrijving

Unit

Datatype

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route
Beschrijving

Route

Datatype

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0392360
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Start Time
Beschrijving

Start Time

Datatype

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Taken Prior to Study?
Beschrijving

Taken Prior to Study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Stop Date
Beschrijving

Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
Stop time
Beschrijving

Stop time

Datatype

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522314
Ongoing Medication?
Beschrijving

Ongoing Medication?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666

Similar models

Concomitant Medications

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Unit
CL Item
Tablet  (TAB)
CL Item
Microlitre  (MCL)
CL Item
Millilitre  (ML)
CL Item
Litre  (L)
CL Item
Microgram  (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Frequency
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Route
integer
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Route
CL Item
Intramuscular (1)
(Comment:en)
CL Item
Inhalation (2)
(Comment:en)
CL Item
Intravenous (3)
(Comment:en)
CL Item
Nasal (4)
(Comment:en)
CL Item
Topical (5)
(Comment:en)
CL Item
Oral (6)
(Comment:en)
CL Item
Vaginal (7)
(Comment:en)
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop time
Item
Stop time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])

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