ID

30327

Description

https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Link

https://clinicaltrials.gov/ct2/show/NCT00486954

Keywords

Versions (1)
  1. 5/29/18 5/29/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 29, 2018

DOI

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License

Creative Commons BY-NC 3.0
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NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

English

PK Sample (paclitaxel)

1 forms  
  1. StudyEvent: ODM
    1. PK Sample (paclitaxel)
Dosing
Description

Dosing

Alias
UMLS CUI-1
C3469597
Dosing date/time
Description

Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Sample Taken
Description

Sample Taken

Data type

integer

Alias
UMLS CUI [1]
C1302413
Sample Taken
Description

Sample Taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
If yes to Sample taken, please give date and time
Description

If yes to Sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0040223
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Similar models

PK Sample (paclitaxel)

1 forms
  1. StudyEvent: ODM
    1. PK Sample (paclitaxel)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dosing
C3469597 (UMLS CUI-1)
Dosing date/time
Item
Dosing date/time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Sample Taken
integer
C1302413 (UMLS CUI [1])
Sample Taken
Code List
Sample Taken
CL Item
Just before the start of infusion (1)
CL Item
0.5 Hour (2)
CL Item
1 Hour (immediately before terminating the infusion) (3)
CL Item
1.5 Hours (4)
CL Item
2 Hours (5)
CL Item
3 Hours (6)
CL Item
4 Hours (7)
CL Item
6 Hours (8)
CL Item
8 Hours (9)
CL Item
12 Hours (10)
CL Item
24 Hours (11)
Sample Taken
Item
Sample Taken
boolean
C0200345 (UMLS CUI [1])
If yes to Sample taken
Item
If yes to Sample taken, please give date and time
datetime
C1302413 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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