Information:
Fel:
ID
22319
Beskrivning
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: Disease History 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
Länk
https://clinicaltrials.gov/ct2/show/NCT00078572
Nyckelord
Versioner (1)
- 29/05/2017 29/05/2017 -
Uppladdad den
29 de maio de 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572
Similar models
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Disease History Screening
C0262926 (UMLS CUI-1)
C1710477 (UMLS CUI-2)
C1710477 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of first diagnosis of breast cancer
Item
Date of first diagnosis of breast cancer
date
C2316983 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,2])
Date of first diagnosis of metastatic breast cancer
Item
Date of first diagnosis of metastatic breast cancer
date
C2316983 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Item
Histology at first diagnosis, check one:
text
C0019638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,2])
CL Item
Infiltrating Duct NOS (IDN)
CL Item
Medullary (M)
CL Item
Lobular Invasive (LI)
CL Item
Mucinous (MU)
CL Item
Tubular (T)
CL Item
Adenocystic (A)
CL Item
Papillary (P)
CL Item
Carcinosarcoma (CA)
CL Item
Other, specify (X)
Item
Estrogen Receptor Status
text
C1719706 (UMLS CUI [1,1])
C1719707 (UMLS CUI [1,2])
C1719707 (UMLS CUI [1,2])
CL Item
ER Positive (EP)
CL Item
ER Negative (EN)
CL Item
ER Status Not Available (EO)
CL Item
PR Positive (PP)
CL Item
PR Negative (PN)
CL Item
PR Status Not Available (PO)
Item
Archived Tumor Tissue: HER2/neu overexpression status (defined as +3 by IHC or +2 by IHC and FISH+.)
text
C1512413 (UMLS CUI [1])
Code List
Archived Tumor Tissue: HER2/neu overexpression status (defined as +3 by IHC or +2 by IHC and FISH+.)
CL Item
Overexpression (OE)
CL Item
Non-overexpression (NE)
Item
Stage of disease at first diagnosis, check one:
integer
C1300072 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C3172269 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
CL Item
Stage I (1)
CL Item
Stage II (2)
CL Item
Stage III (3)
CL Item
Stage IV (4)
Item
Current stage of disease, check one:
integer
C1300072 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,2])
CL Item
Stage IIIb or Stage IIIc with T4 lesion (1)
CL Item
Stage IV (2)
Item
Current site of disease, check one:
text
C0450429 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,2])
CL Item
Visceral (V)
CL Item
Non-Visceral (NV)
local recurrence of the original disease
Item
For subjects who have had surgery: Is there local recurrence of the original disease?
boolean
C0034897 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,2])
metastatic disease site Abdomen/viscera
Item
Is (are) there any current known metastatic disease site(s) in the: Abdomen/viscera
boolean
C0000726 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Adrenals
Item
Is (are) there any current known metastatic disease site(s) in the: Adrenals
boolean
C0001625 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Bone
Item
Is (are) there any current known metastatic disease site(s) in the: Bone
boolean
C0262950 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Bone marrow
Item
Is (are) there any current known metastatic disease site(s) in the: Bone marrow
boolean
C0005953 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Breast
Item
Is (are) there any current known metastatic disease site(s) in the: Breast
boolean
C0006141 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Chest Wall
Item
Is (are) there any current known metastatic disease site(s) in the: Chest Wall
boolean
C0205076 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site CNS
Item
Is (are) there any current known metastatic disease site(s) in the: CNS
boolean
C0686377 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0678222 (UMLS CUI [2])
metastatic disease site Heart
Item
Is (are) there any current known metastatic disease site(s) in the: Heart
boolean
C0018787 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Liver
Item
Is (are) there any current known metastatic disease site(s) in the: Liver
boolean
C0023884 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Lung
Item
Is (are) there any current known metastatic disease site(s) in the: Lung
boolean
C0024109 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Lymph nodes
Item
Is (are) there any current known metastatic disease site(s) in the: Lymph nodes
boolean
C0024204 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Pancreas
Item
Is (are) there any current known metastatic disease site(s) in the: Pancreas
boolean
C0030274 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Peritoneum
Item
Is (are) there any current known metastatic disease site(s) in the: Peritoneum
boolean
C0031153 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Pleura
Item
Is (are) there any current known metastatic disease site(s) in the: Pleura
boolean
C0032225 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Skin
Item
Is (are) there any current known metastatic disease site(s) in the: Skin
boolean
C1123023 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Stomach
Item
Is (are) there any current known metastatic disease site(s) in the: Stomach
boolean
C0038351 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site
Item
Is (are) there any current known metastatic disease site(s) in the: Other, specify
text
C0036525 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0678222 (UMLS CUI [2])
Item Group
Prior Anti-Cancer Surgery Screening
C0543467 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C0920425 (UMLS CUI-2)
Item
Has this subject received surgery for the cancer under study?
text
C0543467 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,2])
Code List
Has this subject received surgery for the cancer under study?
CL Item
Yes (Y)
CL Item
No (N)
Date of surgery
Item
Date of surgery
date
C0011008 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
Procedure
Item
Procedure
text
C0184661 (UMLS CUI [1])
Item Group
Prior Anti-Cancer Systemic Therapy Screening
C1515119 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C0920425 (UMLS CUI-2)
Item
Has this subject received prior anti-cancer systemic therapy for the cancer under study?
text
C1515119 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,2])
Code List
Has this subject received prior anti-cancer systemic therapy for the cancer under study?
CL Item
Yes (Y)
CL Item
No (N)
Regimen no
Item
Regimen no
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Therapy
Item
Therapy
text
C1515119 (UMLS CUI [1])
CL Item
Neo-adjuvant (N )
CL Item
Adjuvant (A )
CL Item
Advanced or metastatic (M )
CL Item
Not applicable (NA )
No. of cycles
Item
No. of cycles
text
C1515119 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Total cumulative dose of Anthracycline
Item
Total cumulative dose of Anthracycline (mg/m2)
float
C0003234 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2])
C3174092 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2])
Date started
Item
Date started
date
C0808070 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,2])
Date stopped
Item
Date stopped
date
C0806020 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,2])
CL Item
Complete response (CR )
CL Item
Partial response (PR )
CL Item
Stable disease (SD )
CL Item
Progressive disease (PD )
CL Item
Unknown (UNK )
CL Item
Not applicable (e.g., adjuvant therapy) (NA )
Date of progression
Item
Date of progression
date
C0011008 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0242656 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Item Group
Prior Anti-Cancer Radiotherapy Screening
C1522449 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C0920425 (UMLS CUI-2)
Item
Has this subject received prior radiotherapy for the cancer under study?
text
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,2])
Code List
Has this subject received prior radiotherapy for the cancer under study?
CL Item
Yes (Y)
CL Item
No (N)
Site
Item
Site
text
C1515974 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
Date started
Item
Date started
date
C0808070 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
Date stopped
Item
Date stopped
date
C0806020 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
Estimated total dose amount
Item
Estimated total dose: amount
float
C1522449 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Estimated total dose units
Item
Estimated total dose: units
text
C1522449 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
CL Item
Complete response (CR )
CL Item
Partial response (PR )
CL Item
Stable disease (SD )
CL Item
Progressive disease (PD )
CL Item
Unknown (UNK )
CL Item
Not applicable (e.g., adjuvant therapy) (NA )
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