Information: This is an outdated version of the data model. You can find a Versions overview via Versions on the left. You can find the newest Version by clicking here.
Information:
Error:
ID
22070
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: Serious Adverse Events 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 (2)
- 5/18/17 5/18/17 -
- 5/29/17 5/29/17 -
Uploaded on
May 18, 2017
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Serious Adverse Events NCT00078572
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Serious Adverse Events NCT00078572
Similar models
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Serious Adverse Events NCT00078572
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
American Hispanic (4)
CL Item
Other (5)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Serious adverse event
Item
Serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1519255 (UMLS CUI [1])
Date of onset
Item
Date of onset
text
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
NCI-CTCAE toxicity
integer
C3887242 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
CL Item
Resolved (R)
CL Item
Resolved with sequelae (S)
CL Item
Not resolved (N)
CL Item
Fatal (F)
Date of resolution or death
Item
Date of resolution or death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (4)
Item
Did subject withdraw from study as a result of this serious AE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Item
Possible Causes of SAE other than Investigational Product(s), check all that apply:
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Possible Causes of SAE other than Investigational Product(s), check all that apply:
CL Item
Disease under study (1)
CL Item
Treatment failure (2)
CL Item
Activity related to study participation (e.g., procedures) (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant disorder (5)
CL Item
Concomitant medication (6)
CL Item
Other (7)
Cause of SAE
Item
Please specify cause of SAE
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Seriousness, check all that apply
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Death (A)
CL Item
Life threatening (B)
CL Item
Hospitalization required or prolonged (C)
CL Item
Disabling or incapacitating (D)
CL Item
Congenital anomaly (E)
CL Item
Other (see definition) (F)
Seriousness
Item
Seriousness, if other please specify
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
If fatal, was an autopsy done/to be performed?
text
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
CL Item
Yes (Y)
CL Item
No (N)