ID

30353

Descripción

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

Palabras clave

Versiones (1)
  1. 29/5/18 29/5/18 - Halim Ugurlu
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

29 de mayo de 2018

DOI

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Licencia

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

Inglés

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

1 formularios  
Safety Assessment of Interstitial Pneumonitis
Descripción

Safety Assessment of Interstitial Pneumonitis

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

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

Tipo de datos

boolean

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

Continutation

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

Continutation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0805733
Status
Descripción

Status

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

concominant medication

Tipo de datos

boolean

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

non-serious adverse events during the study

Tipo de datos

boolean

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

Serious adverse events during the study

Tipo de datos

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?
Descripción

Blood products or blood supportive care products use

Tipo de datos

boolean

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

Concominant Medications

Alias
UMLS CUI-1
C2347852
Drug name
Descripción

Trade name preferred

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Reason for medication
Descripción

Reason for medication

Tipo de datos

text

Alias
UMLS CUI [1]
C2826696
Start Date
Descripción

Start Date

Tipo de datos

date

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

Taken prior to study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Descripción

Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

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