ID

41453

Description

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Keywords

Versions (1)
  1. 10/13/20 10/13/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 13, 2020

DOI

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License

Creative Commons BY 4.0
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Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073

English

Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Conclusion
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date of visit; Assessment Date

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Death
Description

Death

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

Alive (finding)

Data type

text

Alias
UMLS CUI [1]
C2584946
Date of death
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Indicate the primary cause of death
Description

Cause of Death, Primary

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205225
Other, specify
Description

Cause of Death, Primary

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205225
Pregnancy Information
Description

Pregnancy Information

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

Pregnant During the Study

Data type

boolean

Alias
UMLS CUI [1]
C3828490
Study Conclusion
Description

Study Conclusion

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

Study End Date

Data type

date

Alias
UMLS CUI [1]
C2983670
Was the subject discontinued from the study?
Description

Patient withdrawn from trial

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Yes, select primary reason for discontinuation from study
Description

Patient withdrawn from trial, Reason and justification, Primary

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
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Similar models

Conclusion

1 forms
  1. StudyEvent: ODM
    1. Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Death
C0011065 (UMLS CUI-1)
Item
Is the subject alive?
text
C2584946 (UMLS CUI [1])
Level of consciousness
Code List
Is the subject alive?
CL Item
Yes (1)
CL Item
No, enter date of death (2)
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Indicate the primary cause of death
text
C0007465 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Cancer treatment, New
Code List
Indicate the primary cause of death
CL Item
Disease under study  (1)
CL Item
Haematologic toxicity  (2)
CL Item
Non-haematologic toxicity (3)
CL Item
Other, specify (4)
Cause of Death, Primary
Item
Other, specify
text
C0007465 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Pregnant During the Study
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study End Date
Item
Date of subject completion or date of subject discontinuation
date
C2983670 (UMLS CUI [1])
Patient withdrawn from trial
Item
Was the subject discontinued from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Yes, select primary reason for discontinuation from study
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Patient withdrawn from trial, Reason and justification, Primary
Code List
Yes, select primary reason for discontinuation from study
CL Item
Lost to follow-up (1)
CL Item
Protocol violation (2)
CL Item
Subject decided to withdraw from the study  (3)
CL Item
Sponsor terminated study (4)
CL Item
Investigator decision  (5)
CL Item
Other, specify (6)
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