ID

22302

Beschreibung

Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Subject Status / Response Assessment, 6 Month Post-Therapy Follow-up Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Stichworte

Versionen (1)
  1. 29.05.17 29.05.17 -
Hochgeladen am

29. Mai 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer 6 Month Post-Therapy Follow-up NCT00078572

Englisch

XELODA and Lapatinib Advanced or Metastatic Breast Cancer 6 Month Post-Therapy Follow-up NCT00078572

1 Formulare  
Subject Status
Beschreibung

Subject Status

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C1522577
UMLS CUI-3
C0678222
Date of assessment
Beschreibung

Date of assessment

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Is the subject alive?
Beschreibung

If NO, complete the END OF STUDY RECORD.

Datentyp

text

Alias
UMLS CUI [1,1]
C2584946
UMLS CUI [1,2]
C2348568
Has this subject started any anti-cancer therapy since the last contact?
Beschreibung

anti-cancer therapy

Datentyp

text

Alias
UMLS CUI [1]
C0920425
If YES, start date of anti-cancer therapy
Beschreibung

start date of anti-cancer therapy

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0920425
Therapy given
Beschreibung

Therapy given

Datentyp

text

Alias
UMLS CUI [1]
C0920425
Response Assessment
Beschreibung

Response Assessment

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0220825
UMLS CUI-3
C0678222
Has disease progression previously been reported?
Beschreibung

If NO, complete the rest of this page.

Datentyp

text

Alias
UMLS CUI [1]
C0242656
Date of lesion evaluation
Beschreibung

lesion

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0220825
Response assessment, check one:
Beschreibung

Response assessment

Datentyp

text

Alias
UMLS CUI [1]
C0521982
If progressive disease is checked, indicate the primary method of evaluation.
Beschreibung

method

Datentyp

text

Alias
UMLS CUI [1,1]
C0871511
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0220825
Date of symptomatic progression of cancer
Beschreibung

If Symptomatic progression of cancer is checked, complete details below

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0178874
Specify symptoms
Beschreibung

Specify symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0178874
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Ähnliche Modelle

XELODA and Lapatinib Advanced or Metastatic Breast Cancer 6 Month Post-Therapy Follow-up NCT00078572

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Subject Status
C2348568 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0678222 (UMLS CUI-3)
Date of assessment
Item
Date of assessment
date
C0011008 (UMLS CUI [1])
Item
Is the subject alive?
text
C2584946 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Is the subject alive?
Code List
Is the subject alive?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has this subject started any anti-cancer therapy since the last contact?
text
C0920425 (UMLS CUI [1])
Is the subject alive?
Code List
Has this subject started any anti-cancer therapy since the last contact?
CL Item
Yes (Y)
CL Item
No (N)
start date of anti-cancer therapy
Item
If YES, start date of anti-cancer therapy
date
C0808070 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Therapy given
Item
Therapy given
text
C0920425 (UMLS CUI [1])
Item Group
Response Assessment
C0521982 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0678222 (UMLS CUI-3)
Item
Has disease progression previously been reported?
text
C0242656 (UMLS CUI [1])
Is the subject alive?
Code List
Has disease progression previously been reported?
CL Item
Yes (Y)
CL Item
No (N)
lesion
Item
Date of lesion evaluation
date
C0011008 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Item
Response assessment, check one:
text
C0521982 (UMLS CUI [1])
Response assessment
Code List
Response assessment, check one:
CL Item
Complete response (CR)
CL Item
Partial response (PR)
CL Item
Stable disease (SD)
CL Item
Progressive disease (PD)
CL Item
Unknown (U)
Item
If progressive disease is checked, indicate the primary method of evaluation.
text
C0871511 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
primary method of evaluation
Code List
If progressive disease is checked, indicate the primary method of evaluation.
CL Item
Progressive disease by lesion evaluation (PLE)
CL Item
Symptomatic progression of cancer (SPC)
Date of symptomatic progression of cancer
Item
Date of symptomatic progression of cancer
date
C0011008 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
Specify symptoms
Item
Specify symptoms
text
C1457887 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
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