ID

30370

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. 5/30/18 5/30/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 30, 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

Investigational Product Compliance-Lapatinib, Investigational Product Discontinuation

1 forms  
Investigational Product Compliance-Lapatinib
Description

Investigational Product Compliance-Lapatinib

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Date Investigational Product dispensed
Description

Date Investigational Product dispensed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0304229
Total Number Dispensed
Description

Total Number Dispensed

Data type

text

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
Date investigatinal Product returned
Description

Date investigatinal Product returned

Data type

date

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2826249
Total number returned
Description

Total number returned

Data type

text

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Investigational Product
Description

Investigational Product

Data type

integer

Alias
UMLS CUI [1]
C0304229
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Description

Investigational product stopped permanently before the end of the scheduled treatment period

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
If yes, specify the primary reason the investigational product was stopped
Description

Specify the primary reason the investigational product was stopped

Data type

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0457454
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Similar models

Investigational Product Compliance-Lapatinib, Investigational Product Discontinuation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigational Product Compliance-Lapatinib
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Date Investigational Product dispensed
Item
Date Investigational Product dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Total Number Dispensed
Item
Total Number Dispensed
text
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Date investigatinal Product returned
Item
Date investigatinal Product returned
date
C0013230 (UMLS CUI [1,1])
C2826249 (UMLS CUI [1,2])
Total number returned
Item
Total number returned
text
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Investigational Product
Code List
Investigational Product
CL Item
Lapatinib (1)
CL Item
Paclitaxel (2)
Investigational product stopped permanently before the end of the scheduled treatment period
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Item
If yes, specify the primary reason the investigational product was stopped
integer
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Specify the primary reason the investigational product was stopped
Code List
If yes, specify the primary reason the investigational product was stopped
CL Item
Adverse evetn, record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor termined study (6)
CL Item
Disease progression (7)
CL Item
Death (25)
CL Item
Subject decided to withdraw from IP but is to be followed for survival per protocol (27)
CL Item
Other, Specify (0)
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