ID

30353

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

Safety Assessment of Interstitial Pneumonitis, Continutation, Status, Concominant Medications

1 forms  
Safety Assessment of Interstitial Pneumonitis
Description

Safety Assessment of Interstitial Pneumonitis

Alias
UMLS CUI-1
C0206061
Was a chest CT, MRI or x-ray performed as surveillance for interstitial pneumonitis?
Description

If yes, record any findings in teh Adverse Events or Serious Adverse Events from as appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0733511
UMLS CUI [1,4]
C0011923
Continutation
Description

Continutation

Alias
UMLS CUI-1
C0805733
Will the subject start the next cycle?
Description

Continutation

Data type

boolean

Alias
UMLS CUI [1]
C0805733
Status
Description

Status

Alias
UMLS CUI-1
C0449438
Were any concominant medications taken by the subject prior to screening and/or during study?
Description

concominant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Description

non-serious adverse events during the study

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Description

Serious adverse events during the study

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Were any blood products or blood supportive care products used for the subject prior to screening and/or during study?
Description

Blood products or blood supportive care products use

Data type

boolean

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C0457083
Concominant Medications
Description

Concominant Medications

Alias
UMLS CUI-1
C2347852
Drug name
Description

Trade name preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Reason for medication
Description

Reason for medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Taken prior to study?
Description

Taken prior to study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Description

Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Safety Assessment of Interstitial Pneumonitis, Continutation, Status, Concominant Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Safety Assessment of Interstitial Pneumonitis
C0206061 (UMLS CUI-1)
CT, MRI or x-ray performed as surveillance for interstitial pneumonitis
Item
Was a chest CT, MRI or x-ray performed as surveillance for interstitial pneumonitis?
boolean
C0206061 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0733511 (UMLS CUI [1,3])
C0011923 (UMLS CUI [1,4])
Item Group
Continutation
C0805733 (UMLS CUI-1)
Continutation
Item
Will the subject start the next cycle?
boolean
C0805733 (UMLS CUI [1])
Item Group
Status
C0449438 (UMLS CUI-1)
concominant medication
Item
Were any concominant medications taken by the subject prior to screening and/or during study?
boolean
C2347852 (UMLS CUI [1])
non-serious adverse events during the study
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Serious adverse events during the study
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Blood products or blood supportive care products use
Item
Were any blood products or blood supportive care products used for the subject prior to screening and/or during study?
boolean
C0456388 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Item Group
Concominant Medications
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Taken prior to study?
Item
Taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
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