ID

22298

Description

XELODA and Lapatinib Advanced or Metastatic Breast Cancer 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: Non-measurable Disease (Non-target Lesions) Assessment 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

Keywords

Versions (1)
  1. 5/29/17 5/29/17 -
Uploaded on

May 29, 2017

DOI

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License

Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-measurable Disease NCT00078572

English

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-measurable Disease NCT00078572

1 forms  
Non-measurable Disease (Non-target Lesions) Assessment
Description

Non-measurable Disease (Non-target Lesions) Assessment

Alias
UMLS CUI-1
C2986547
UMLS CUI-2
C0220825
UMLS CUI-3
C1518373
UMLS CUI-4
C0012634
Did this subject have non-measurable disease at Screening?
Description

non-measurable disease at screening

Data type

text

Alias
UMLS CUI [1,1]
C1518373
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C1710477
Lesion number
Description

Lesion number

Data type

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0221198
Lesion location
Description

Lesion location: Provide a brief description of the location of each lesion within the organ. If it is not possible to describe the location further, line through the lesion location box in the lesion location column. If an organ contains more than one lesion, lesion location descriptions must be recorded.

Data type

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0450429
Organ code
Description

code

Data type

text

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0805701
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0450429
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0221198
Longest Diameter
Description

Longest Diameter

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0552406
UMLS CUI [1,2]
C0221198
mm
Method
Description

Method

Data type

text

Alias
UMLS CUI [1,1]
C0871511
UMLS CUI [1,2]
C0221198
Assessment 2
Description

Assessment 2

Alias
UMLS CUI-1
C2986547
UMLS CUI-2
C0220825
UMLS CUI-3
C1518373
UMLS CUI-4
C0012634
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0221198
Longest Diameter
Description

Longest Diameter

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0552406
UMLS CUI [1,2]
C0221198
mm
Method
Description

Method

Data type

text

Alias
UMLS CUI [1,1]
C0871511
UMLS CUI [1,2]
C0221198
Lesion Status
Description

Lesion Status

Data type

text

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0221198
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Similar models

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-measurable Disease NCT00078572

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-measurable Disease (Non-target Lesions) Assessment
C2986547 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1518373 (UMLS CUI-3)
C0012634 (UMLS CUI-4)
Item
Did this subject have non-measurable disease at Screening?
text
C1518373 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1710477 (UMLS CUI [2])
measurable disease at screening
Code List
Did this subject have non-measurable disease at Screening?
CL Item
Yes (Y)
CL Item
No (N)
Lesion number
Item
Lesion number
text
C0237753 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Lesion location
Item
Lesion location
text
C0237753 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Item
Organ code
text
C0178784 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0450429 (UMLS CUI [2,2])
Organ code
Code List
Organ code
CL Item
Abdomen/viscera AD = Adrenals (AB)
CL Item
Breast (BT)
CL Item
CNS  (CS)
CL Item
Heart  (HT)
CL Item
Liver  (LV)
CL Item
Lung (LG)
CL Item
Lymph nodes  (LN)
CL Item
Pancreas (PS)
CL Item
Skin (SK)
CL Item
Chest Wall (CW)
CL Item
Peritoneum  (PM)
CL Item
Pleura (PA)
CL Item
Stomach  (SH)
CL Item
Kidney (KID)
CL Item
Other (XX)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Longest Diameter
Item
Longest Diameter
float
C0552406 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Method
text
C0871511 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Method
Code List
Method
CL Item
Conventional CT scan (C)
CL Item
Direct measure by physical exam (D)
CL Item
Lymphangiogram (L)
CL Item
Magnetic resonance imaging (M)
CL Item
X-ray (X)
CL Item
Spiral CT  (SC)
CL Item
Endoscopy (E)
CL Item
Medical photography  (P)
CL Item
Nuclear scan (NS)
CL Item
Not done (ND)
Item Group
Assessment 2
C2986547 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1518373 (UMLS CUI-3)
C0012634 (UMLS CUI-4)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Longest Diameter
Item
Longest Diameter
float
C0552406 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Method
text
C0871511 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Method
Code List
Method
CL Item
Conventional CT scan (C)
CL Item
Direct measure by physical exam (D)
CL Item
Lymphangiogram (L)
CL Item
Magnetic resonance imaging (M)
CL Item
X-ray (X)
CL Item
Spiral CT  (SC)
CL Item
Endoscopy (E)
CL Item
Medical photography  (P)
CL Item
Nuclear scan (NS)
CL Item
Not done (ND)
Item
Lesion Status
text
C0449438 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Lesion Status
Code List
Lesion Status
CL Item
New Measurable Lesion (N)
CL Item
Lesion Split or Divided (S)
CL Item
Lesion Merged or Coalesced (M)
CL Item
Not Done (ND)
CL Item
Not Assessable (disease assessment performed but lesion could not be sufficiently assessed to determine the status) (NA)
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