ID

30372

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

Study Conclusion, Treatment Confirmation, Pregnancy Information, Death

1 forms  
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or date of subject withdrawal
Description

Date of subject completion or date of subject withdrawal

Data type

date

Alias
UMLS CUI [1,1]
C2983670
UMLS CUI [1,2]
C0422727
UMLS CUI [2]
C0805732
Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If yes to withdrawn, plese select primary reason for withdrawal
Description

If yes to withdrawn

Data type

integer

Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Treatment Confirmation

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If no, please record reasons
Description

If no, please record reasons

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2348235
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

If yes, complete the paper Pregnancy Notification form

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Did a female partner of the male subject become pregnant during the study?
Description

If yes, complete the paper Pregnancy Notification form

Data type

integer

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Death
Description

Death

Alias
UMLS CUI-1
C0011065
Is the subject alive?
Description

Is the subject alive?

Data type

boolean

Alias
UMLS CUI [1,1]
C2584946
UMLS CUI [1,2]
C2348568
If no please enter date of death
Description

If no please enter date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Primary cause of death
Description

Primary cause of death

Data type

integer

Alias
UMLS CUI [1]
C0007465
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Similar models

Study Conclusion, Treatment Confirmation, Pregnancy Information, Death

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or date of subject withdrawal
Item
Date of subject completion or date of subject withdrawal
date
C2983670 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C0805732 (UMLS CUI [2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If yes to withdrawn, plese select primary reason for withdrawal
integer
If yes to withdrawn
Code List
If yes to withdrawn, plese select primary reason for withdrawal
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
Invesitagor decision (26)
CL Item
Other, Specify (0)
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Treatment Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If no, please record reasons
Item
If no, please record reasons
text
C0087111 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Did a female partner of the male subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
undefined item
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (if female partner not of childbearing potential or no female partner) (3)
Item Group
Death
C0011065 (UMLS CUI-1)
Is the subject alive?
Item
Is the subject alive?
boolean
C2584946 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
If no please enter date of death
Item
If no please enter date of death
date
C1148348 (UMLS CUI [1])
Item
Primary cause of death
integer
C0007465 (UMLS CUI [1])
Primary cause of death
Code List
Primary cause of death
CL Item
Disease under study (1)
CL Item
Other, specify (2)
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