ID

30308

Beschreibung

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

Stichworte

Versionen (1)
  1. 28.05.18 28.05.18 - Halim Ugurlu
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

28. Mai 2018

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Local Laboratory - Haematology (Haema)
Beschreibung

Local Laboratory - Haematology (Haema)

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

Laboratory name and address

Datentyp

text

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

Date sample taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Results-haema
Beschreibung

Results-haema

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

Results-haema

Datentyp

integer

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

Type of Result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
If Numeric Result
Beschreibung

If Numeric Result

Datentyp

text

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

If Character Result

Datentyp

text

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

Local Laboratory - Clinical Chemistry (Chem)

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

Laboratory name and address

Datentyp

text

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

Date sample taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Results-Chem
Beschreibung

Results-Chem

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

Results-Chem

Datentyp

integer

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

Type of Result

Datentyp

integer

Alias
UMLS CUI [1]
C1274040
If Numeric Result
Beschreibung

If Numeric Result

Datentyp

text

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

If Character Result

Datentyp

text

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

12-Lead Electrocardiogram (ECG)

Alias
UMLS CUI-1
C0430456
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Beschreibung

Result of ECG

Datentyp

integer

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

Echocardiogram or Multigated Acquisition (ECHO)

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

Name of Institution that performed the scan

Datentyp

text

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

Ejection fraction range lower limit

Datentyp

text

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

Scan Type

Datentyp

integer

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

Date of scan

Datentyp

date

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

LVEF

Datentyp

text

Alias
UMLS CUI [1]
C0428772
Result of Scan
Beschreibung

Result of Scan

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0013516
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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