ID

30308

Description

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

Link

https://clinicaltrials.gov/ct2/show/NCT00486954

Keywords

Versions (1)
  1. 5/28/18 5/28/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 28, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

English

Screening-3 (local laboratory-haematology and clinical chemistry, 12-lead ECG, Echocardiogram)

1 forms  
Local Laboratory - Haematology (Haema)
Description

Local Laboratory - Haematology (Haema)

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0474523
Laboratory name and address
Description

Laboratory name and address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0027365
UMLS CUI [1,3]
C0022877
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Results-haema
Description

Results-haema

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0018941
Results-haema
Description

Results-haema

Data type

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0018941
Type of Result
Description

Type of Result

Data type

integer

Alias
UMLS CUI [1]
C1274040
If Numeric Result
Description

If Numeric Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2347373
If Character Result
Description

If Character Result

Data type

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Local Laboratory - Clinical Chemistry (Chem)
Description

Local Laboratory - Clinical Chemistry (Chem)

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Laboratory name and address
Description

Laboratory name and address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0027365
UMLS CUI [1,3]
C0022877
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Results-Chem
Description

Results-Chem

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0008000
Results-Chem
Description

Results-Chem

Data type

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0008000
Type of Result
Description

Type of Result

Data type

integer

Alias
UMLS CUI [1]
C1274040
If Numeric Result
Description

If Numeric Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2347373
If Character Result
Description

If Character Result

Data type

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
12-Lead Electrocardiogram (ECG)
Description

12-Lead Electrocardiogram (ECG)

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Description

Result of ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Echocardiogram or Multigated Acquisition (ECHO)
Description

Echocardiogram or Multigated Acquisition (ECHO)

Alias
UMLS CUI-1
C0013516
UMLS CUI-3
C0521317
Name of Institution that performed the scan
Description

Name of Institution that performed the scan

Data type

text

Alias
UMLS CUI [1]
C1301943
Ejection fraction range lower limit
Description

Ejection fraction range lower limit

Data type

text

Alias
UMLS CUI [1,1]
C2700378
UMLS CUI [1,2]
C0086715
UMLS CUI [1,3]
C2827739
Scan Type
Description

Scan Type

Data type

integer

Alias
UMLS CUI [1]
C0013516
UMLS CUI [2]
C0521317
Date of scan
Description

Date of scan

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013516
Left ventricula ejection fraction (LVEF)
Description

LVEF

Data type

text

Alias
UMLS CUI [1]
C0428772
Result of Scan
Description

Result of Scan

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0013516
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Similar models

Screening-3 (local laboratory-haematology and clinical chemistry, 12-lead ECG, Echocardiogram)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Local Laboratory - Haematology (Haema)
C1254595 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory name and address
Item
Laboratory name and address
text
C1442065 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item Group
Results-haema
C1254595 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Item
Results-haema
integer
C1254595 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Results-haema
Code List
Results-haema
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Haemoglobin (3)
CL Item
Haemotocrit (4)
CL Item
Total Neutrophils(%) (5)
CL Item
Lymphocytes(%) (6)
CL Item
Monocytes(%) (7)
CL Item
Eosinophils(%) (8)
CL Item
Basophils(%) (9)
CL Item
Platelets (10)
Item
Type of Result
integer
C1274040 (UMLS CUI [1])
Result List
Code List
Type of Result
CL Item
Numeric Result (1)
CL Item
Character Result (2)
CL Item
No Result (3)
If Numeric Result
Item
If Numeric Result
text
C0474523 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
If Character Result
Item
If Character Result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Local Laboratory - Clinical Chemistry (Chem)
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Laboratory name and address
Item
Laboratory name and address
text
C1442065 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item Group
Results-Chem
C1254595 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Results-Chem
integer
C1254595 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Results-Chem
Code List
Results-Chem
CL Item
ALT (1)
CL Item
AST (2)
CL Item
total bilirubin (3)
CL Item
Glucose (4)
CL Item
total Protein (5)
CL Item
Albumin (6)
CL Item
Potassium (7)
CL Item
Sodium (8)
CL Item
Chloride (9)
CL Item
Blood Urea Nitrogen (10)
CL Item
Urea (11)
CL Item
Uric Acid (12)
CL Item
Calcium (13)
CL Item
Alkaline Phosphatase (14)
CL Item
Creatinine (15)
CL Item
Calculated Creatinine Clearence (16)
Item
Type of Result
integer
C1274040 (UMLS CUI [1])
Result List
Code List
Type of Result
CL Item
Numeric Result (1)
CL Item
Character Result (2)
CL Item
No Result (3)
If Numeric Result
Item
If Numeric Result
text
C0474523 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
If Character Result
Item
If Character Result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
12-Lead Electrocardiogram (ECG)
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
Result of ECG
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal, clinically significant (complete the AE/SAE form if clinically significant abnormalities meet the protocol for an AE/SAE) (3)
CL Item
No result (not available) (4)
Item Group
Echocardiogram or Multigated Acquisition (ECHO)
C0013516 (UMLS CUI-1)
C0521317 (UMLS CUI-3)
Name of Institution that performed the scan
Item
Name of Institution that performed the scan
text
C1301943 (UMLS CUI [1])
Ejection fraction range lower limit
Item
Ejection fraction range lower limit
text
C2700378 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C2827739 (UMLS CUI [1,3])
Item
Scan Type
integer
C0013516 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
Scan Type
Code List
Scan Type
CL Item
ECHO (1)
CL Item
MUGA (2)
Date of scan
Item
Date of scan
date
C0011008 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
LVEF
Item
Left ventricula ejection fraction (LVEF)
text
C0428772 (UMLS CUI [1])
Item
Result of Scan
text
C1274040 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Result of Scan
Code List
Result of Scan
CL Item
Normal (1)
CL Item
Abnormal, please describe (2)
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