ID

30321

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

  1. 5/28/18 5/28/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 28, 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

Investigational Product

Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Description

Investigational Product

Data type

integer

Alias
UMLS CUI [1]
C0304229
Start Date and Time
Description

Start Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
Stop Date and Time
Description

Stop Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522314
Dose
Description

Dose

Data type

integer

Measurement units
  • mg/m²
Alias
UMLS CUI [1]
C3174092
mg/m²
Actual Dose
Description

Actual Dose

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose Modifications
Description

Dose Modifications

Alias
UMLS CUI-1
C1707811
Was dose delayed?
Description

Was dose delayed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1299700
If yes to delayed dose
Description

If yes to delayed dose

Data type

text

Was dose reduced?
Description

Was dose reduced?

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0547047
If yes to dose reduce
Description

If yes to dose reduce

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0547047

Similar models

Investigational Product

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Code List
Investigational Product
CL Item
Lapatinib (1)
CL Item
Paclitaxel (2)
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Stop Date and Time
Item
Stop Date and Time
datetime
C0806020 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Actual Dose
Item
Actual Dose
integer
C3174092 (UMLS CUI [1])
Item Group
Dose Modifications
C1707811 (UMLS CUI-1)
Was dose delayed?
Item
Was dose delayed?
boolean
C0178602 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
Item
If yes to delayed dose
text
Code List
If yes to delayed dose
CL Item
Neurologic Toxicity (11)
CL Item
Hematologic Toxicity (1)
CL Item
Other, specify (OT)
Was dose reduced?
Item
Was dose reduced?
boolean
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Item
If yes to dose reduce
text
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Code List
If yes to dose reduce
CL Item
Neurologic Toxicity (11)
CL Item
Hematologic Toxicity (1)
CL Item
Other, specify (OT)

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