ID

18373

Beschrijving

Rollover Study Of Lapatinib In Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00169533

Link

https://clinicaltrials.gov/show/NCT00169533

Trefwoorden

Versies (2)
  1. 31/10/16 31/10/16 -
  2. 2/11/16 2/11/16 -
Geüploaded op

2 de noviembre de 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Neoplasms, Breast NCT00169533

Engels

Eligibility Neoplasms, Breast NCT00169533

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently receiving clinical benefit as defined by cr, pr or sd from treatment with lapatinib through participation in a phase i study of lapatinib either as monotherapy or as part of a combination regimen.
Beschrijving

Study Subject Participation Status | lapatinib | Therapeutic procedure | Combined Modality Therapy | Tumor status In complete remission | Tumor status partial response | Tumor status Stable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1506770
UMLS CUI [3]
C0087111
UMLS CUI [4]
C0009429
UMLS CUI [5,1]
C0475752
UMLS CUI [5,2]
C0677874
UMLS CUI [6,1]
C0475752
UMLS CUI [6,2]
C1521726
UMLS CUI [7,1]
C0475752
UMLS CUI [7,2]
C0677946
ability to understand and provide written informed consent to participate in this trial.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
is male or female.
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
female and male subjects agree to the protocol specific birth control measures
Beschrijving

Gender | Contraceptive methods agreement

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0680240
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
Beschrijving

lapatinib Discontinued Permanent | intolerance to lapatinib | lapatinib treatment failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1506770
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0205355
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1506770
UMLS CUI [3,1]
C1506770
UMLS CUI [3,2]
C0162643
is a pregnant or lactating female.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
Beschrijving

Medically unfit Related Clinical Trial | patient interview | Physical Examination | Screening procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C3841806
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C0683518
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0220908
currently receiving treatment with any medications listed on the prohibited medication list (see section 7.2).
Beschrijving

Illicit drug use

Datatype

boolean

Alias
UMLS CUI [1]
C0281875
has class iii or iv heart failure as defined by the new york heart association (nyha) functional classification system.
Beschrijving

Heart failure | New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
has a left ventricular ejection fraction (lvef) < 40% based on muga or echo.
Beschrijving

Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0521317
UMLS CUI [3]
C0013516
Terug naar het begin van de pagina

Similar models

Eligibility Neoplasms, Breast NCT00169533

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | lapatinib | Therapeutic procedure | Combined Modality Therapy | Tumor status In complete remission | Tumor status partial response | Tumor status Stable Disease
Item
currently receiving clinical benefit as defined by cr, pr or sd from treatment with lapatinib through participation in a phase i study of lapatinib either as monotherapy or as part of a combination regimen.
boolean
C2348568 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
C0475752 (UMLS CUI [5,1])
C0677874 (UMLS CUI [5,2])
C0475752 (UMLS CUI [6,1])
C1521726 (UMLS CUI [6,2])
C0475752 (UMLS CUI [7,1])
C0677946 (UMLS CUI [7,2])
Informed Consent
Item
ability to understand and provide written informed consent to participate in this trial.
boolean
C0021430 (UMLS CUI [1])
Gender
Item
is male or female.
boolean
C0079399 (UMLS CUI [1])
Gender | Contraceptive methods agreement
Item
female and male subjects agree to the protocol specific birth control measures
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
lapatinib Discontinued Permanent | intolerance to lapatinib | lapatinib treatment failure
Item
permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
boolean
C1506770 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C1506770 (UMLS CUI [2,2])
C1506770 (UMLS CUI [3,1])
C0162643 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
is a pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medically unfit Related Clinical Trial | patient interview | Physical Examination | Screening procedure
Item
is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
boolean
C3841806 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
Illicit drug use
Item
currently receiving treatment with any medications listed on the prohibited medication list (see section 7.2).
boolean
C0281875 (UMLS CUI [1])
Heart failure | New York Heart Association Classification
Item
has class iii or iv heart failure as defined by the new york heart association (nyha) functional classification system.
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography
Item
has a left ventricular ejection fraction (lvef) < 40% based on muga or echo.
boolean
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial