ID

22315

Beschreibung

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: Investigational Product 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

Stichworte

Versionen (1)
  1. 29.05.17 29.05.17 -
Hochgeladen am

29. Mai 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Investigational Product NCT00078572

Englisch

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Investigational Product NCT00078572

1 Formulare  
Investigational Product - GW572016
Beschreibung

Investigational Product - GW572016

Alias
UMLS CUI-1
C0304229
Dose
Beschreibung

Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop date
Beschreibung

Stop date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
If there were any dosing deviations / changes, give reason(s)
Beschreibung

reason for dosing deviations changes

Datentyp

integer

Alias
UMLS CUI [1,1]
C1515926
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0392360
Investigational Product Compliance
Beschreibung

Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Date tablets dispensed
Beschreibung

Date tablets dispensed

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0304229
Number of tablets dispensed
Beschreibung

Number of tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0304229
Number of tablets returned
Beschreibung

Number of tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0304229
Investigational Product - Capecitabine
Beschreibung

Investigational Product - Capecitabine

Alias
UMLS CUI-1
C0671970
Dose
Beschreibung

Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop date
Beschreibung

Stop date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
If there were any dosing deviations / changes, give reason(s)
Beschreibung

reason for dosing deviations changes

Datentyp

integer

Alias
UMLS CUI [1,1]
C1515926
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0392360
Date tablets dispensed
Beschreibung

Date tablets dispensed

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0671970
Tablet Strength in mg
Beschreibung

Tablet Strength in mg

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1]
C0671970
mg
Number of tablets dispensed
Beschreibung

Number of tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0671970
Number of tablets returned
Beschreibung

Number of tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0671970
Investigational Product Discontinuation
Beschreibung

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently?
Beschreibung

investigational product stopped

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
If YES, check the primary reason the investigational product was stopped permanently, check one:
Beschreibung

primary reason the investigational product was stopped

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0457454
primary reason the investigational product was stopped: If other, please specify
Beschreibung

primary reason the investigational product was stopped

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0457454
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Ähnliche Modelle

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Investigational Product NCT00078572

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Investigational Product - GW572016
C0304229 (UMLS CUI-1)
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
If there were any dosing deviations / changes, give reason(s)
integer
C1515926 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for dosing deviations changes
Code List
If there were any dosing deviations / changes, give reason(s)
CL Item
Hematological toxicity (31)
CL Item
Non-Hematological toxicity (6)
CL Item
Subject non-compliant (9)
CL Item
Other (99)
Item Group
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Date tablets dispensed
Item
Date tablets dispensed
date
C0011008 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Investigational Product - Capecitabine
C0671970 (UMLS CUI-1)
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
If there were any dosing deviations / changes, give reason(s)
integer
C1515926 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for dosing deviations changes
Code List
If there were any dosing deviations / changes, give reason(s)
CL Item
Hematological toxicity (31)
CL Item
Non-Hematological toxicity (6)
CL Item
Subject non-compliant (9)
CL Item
Other (99)
Date tablets dispensed
Item
Date tablets dispensed
date
C0011008 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0671970 (UMLS CUI [1,3])
Tablet Strength in mg
Item
Tablet Strength in mg
integer
C0671970 (UMLS CUI [1])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0671970 (UMLS CUI [1,3])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0671970 (UMLS CUI [1,3])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Was the investigational product stopped permanently?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
investigational product stopped
Code List
Was the investigational product stopped permanently?
CL Item
Yes (Y)
CL Item
No (N)
Item
If YES, check the primary reason the investigational product was stopped permanently, check one:
text
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
primary reason the investigational product was stopped
Code List
If YES, check the primary reason the investigational product was stopped permanently, check one:
CL Item
Adverse event (A)
CL Item
Consent withdrawn (C)
CL Item
Lost to follow up (L)
CL Item
Protocol violation (P)
CL Item
Progression of cancer (PD)
CL Item
Death (D)
CL Item
Discontinuation of study by sponsor (B)
CL Item
Other (X)
primary reason the investigational product was stopped
Item
primary reason the investigational product was stopped: If other, please specify
text
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
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