Information:
Fel:
ID
30306
Beskrivning
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609
Länk
https://clinicaltrials.gov/ct2/show/NCT00486954
Nyckelord
Versioner (1)
- 2018-05-28 2018-05-28 - Halim Ugurlu
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
28 maj 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer
Screening-2 (disease, status, anti-cancer therapy, cancer related therapies)
Similar models
Screening-2 (disease, status, anti-cancer therapy, cancer related therapies)
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item
Primary Tumor type at Initial diagnosis
text
C0677930 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Stomach (1)
CL Item
Other, specify (2)
Date of Initial Diagnosis
Item
Date of Initial Diagnosis
date
C2316983 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,2])
CL Item
1a (1)
CL Item
1b (2)
CL Item
2 (3)
CL Item
3a (4)
CL Item
3b (5)
CL Item
4 (6)
Item
Histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C3172269 (UMLS CUI [1,2])
CL Item
Papillary Adenocarcinoma (11)
CL Item
Adenosquamous carcinoma (41)
CL Item
Poorly Differentiated adenocarcinoma (48)
CL Item
Signet-Ring cell carcinoma (49)
CL Item
Mucinous adenocarcinoma (50)
CL Item
Carcinoid Tumor (51)
CL Item
Squamoz Cell carcinoma (7)
CL Item
Tubular adenocarcinoma (9)
CL Item
Other, specify (OT)
Item
Histological Grade at Initial Diagnosis
integer
C0919553 (UMLS CUI [1,1])
C4071762 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,2])
CL Item
Grade cannot be assessed (0)
CL Item
Well differentiated (1)
CL Item
Moderetely Differentiated (2)
CL Item
Poorly Differentiated (3)
CL Item
Undifferentiated (4)
Date of Staging at Screening
Item
Date of Staging at Screening
date
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C0027646 (UMLS CUI [1,2])
Item
Stage at Screening
integer
C1300072 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
CL Item
1a (1)
CL Item
1b (2)
CL Item
2 (3)
CL Item
3a (4)
CL Item
3b (5)
CL Item
4 (6)
Item
Histologic grade at screening
integer
C0919553 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
CL Item
Grade cannot be assessed (0)
CL Item
Well differentiated (1)
CL Item
Moderetely Differentiated (2)
CL Item
Poorly Differentiated (3)
CL Item
Undifferentiated (4)
Item Group
Disease Characteristics (Metastasis)
C0599878 (UMLS CUI-1)
C0027627 (UMLS CUI-2)
C0027627 (UMLS CUI-2)
Metastatic Disease at Screening
Item
Metastatic Disease at Screening
boolean
C2939420 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
Item
Metastasis Abdomen/Abdominal Wall
integer
C0836916 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Adrenals
integer
C0001625 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Bladder
integer
C0005682 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Breast
integer
C0678222 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Cervix
integer
C0007874 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Chest Wall
integer
C0205076 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Esophagus/Oesophagus
integer
C0014876 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Head and Neck
integer
C0460004 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Kidney
integer
C0022646 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Lymph Nodes
integer
C0024204 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Oral Cavity
integer
C0226896 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Pancreas
integer
C0030274 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Peritoneum
integer
C0031153 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Pleura
integer
C0032225 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Prostate
integer
C0033572 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Rectum
integer
C0034896 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Small Intestine
integer
C0021852 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Spleen
integer
C0037993 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Testicle
integer
C0039597 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Thyroid
integer
C0040132 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
CL Item
Not Assessed (1)
CL Item
No (2)
CL Item
Yes, please specify (3)
anti-cancer medical therapies
Item
Has the subject had any anti-cancer medical therapies?
boolean
C0205156 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0332157 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
anti-cancer radiotherapies
Item
Has the subject had any anti-cancer radiotherapies?
boolean
C0279134 (UMLS CUI [1])
cancer related current medical conditions
Item
Does the subject have any cancer related current medical conditions?
boolean
C3899485 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
non-cancer related current medical conditions
Item
Does the subject have any non-cancer related current medical conditions?
boolean
C3899485 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0445356 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,2])
C0445356 (UMLS CUI [1,3])
Item Group
Prior Anti-cancer therapy
C0920425 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C1514463 (UMLS CUI-2)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Regiment Sequence
Item
Regiment Sequence
text
C2348184 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
Biologic therapy (antibodies, cytokines) (1)
CL Item
Chemotherapy (cytotoxics, non-cytotoxics) (2)
CL Item
Immunotherapy (3)
Cumulative Dose of Anthracyclines
Item
Cumulative Dose of Anthracyclines
text
C2986497 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0282564 (UMLS CUI [1,2])
Item
Intent
integer
C1283828 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or metastatic (3)
CL Item
local/regional (4)
CL Item
Maintenance (12)
CL Item
not Applicable (0)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Cumulative Dose
Item
Cumulative Dose
text
C2986497 (UMLS CUI [1])
Units
Item
Units
text
C0439148 (UMLS CUI [1,1])
C0034619 (UMLS CUI [1,2])
C0034619 (UMLS CUI [1,2])
Item
Intent
integer
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or metastatic (3)
CL Item
Local/REgional (4)
CL Item
Prophylactic (5)
CL Item
Palliative (7)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Cancer Related Surgical Procedures
C0543467 (UMLS CUI-1)
C2826292 (UMLS CUI-2)
C2826292 (UMLS CUI-2)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
If yes to gastrectomy
integer
C0017118 (UMLS CUI [1])
C0030600 (UMLS CUI [2])
C0030600 (UMLS CUI [2])
CL Item
Partial gastrectomy (pybrus spared) (1)
CL Item
Total/partial gastrectomy (pylorus removed) (2)
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1])
Item Group
Cancer Related Current Medical Conditions
C3899485 (UMLS CUI-1)
C0678226 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
C0678226 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Status
Item
Status, current?
boolean
C0521116 (UMLS CUI [1])
Item
Classification code
text
C0008902 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
CL Item
Cancer related (24)
CL Item
Toxicities related to previous therapy (29)
CL Item
Other (general) (OT)
CL Item
grade 1 (1)
CL Item
grade 2 (2)
CL Item
grade 3 (3)
CL Item
grade 4 (4)
CL Item
not Applicable (X)
Item Group
Non-Cancer Related Current Medical Conditions
C3899485 (UMLS CUI-1)
C3640974 (UMLS CUI-2)
C0678226 (UMLS CUI-3)
C0006826 (UMLS CUI-4)
C3640974 (UMLS CUI-2)
C0678226 (UMLS CUI-3)
C0006826 (UMLS CUI-4)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Status
Item
Status, current?
boolean
C0521116 (UMLS CUI [1])
Item
Classification code
text
C0008902 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
CL Item
Cancer related (24)
CL Item
Toxicities related to previous therapy (29)
CL Item
Other (general) (OT)
CL Item
grade 1 (1)
CL Item
grade 2 (2)
CL Item
grade 3 (3)
CL Item
grade 4 (4)
CL Item
not Applicable (X)
Actual Date
Item
Actual Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
text
C0005823 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])