ID

14955

Description

Open Label Extension Study of Conatumumab and AMG 479; ODM derived from: https://clinicaltrials.gov/show/NCT01327612

Link

https://clinicaltrials.gov/show/NCT01327612

Keywords

  1. 5/9/16 5/9/16 -
Uploaded on

May 9, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Advanced Solid Tumors NCT01327612

Eligibility Advanced Solid Tumors NCT01327612

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be enrolled in this study, subjects must be currently enrolled in a prior amgen-sponsored conatumumab or amg 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or amg 479 alone.
Description

conatumumab

Data type

boolean

Alias
UMLS CUI [1]
C2346822
subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol
Description

Eligibility

Data type

integer

Alias
UMLS CUI [1]
C0013893
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
discontinued from a conatumumab study due to an adverse event considered by the investigator to be related to conatumumab treatment, including intolerance to conatumumab
Description

adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2346822
subjects determined to have disease progression during their participation in the parent amgen study
Description

disease progression

Data type

boolean

Alias
UMLS CUI [1]
C0242656
woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last dose of protocol-specified therapy administration
Description

contraceptive

Data type

boolean

Alias
UMLS CUI [1]
C0700589
subject is pregnant or breast feeding, or planning to become pregnant within 6 months after the last dose of protocol-specified therapy administration
Description

pregnant or breast feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
male subject with a pregnant partner who is not willing to use a condom during treatment and for an additional 6 months after the last dose of protocol-specified therapy administration
Description

condom

Data type

boolean

Alias
UMLS CUI [1]
C3174747
subject has previously entered this study
Description

subject has previously entered this study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge
Description

study visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C2603343
subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
Description

Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1511481

Similar models

Eligibility Advanced Solid Tumors NCT01327612

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
conatumumab
Item
to be enrolled in this study, subjects must be currently enrolled in a prior amgen-sponsored conatumumab or amg 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or amg 479 alone.
boolean
C2346822 (UMLS CUI [1])
Eligibility
Item
subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol
integer
C0013893 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
adverse event
Item
discontinued from a conatumumab study due to an adverse event considered by the investigator to be related to conatumumab treatment, including intolerance to conatumumab
boolean
C0877248 (UMLS CUI [1,1])
C2346822 (UMLS CUI [1,2])
disease progression
Item
subjects determined to have disease progression during their participation in the parent amgen study
boolean
C0242656 (UMLS CUI [1])
contraceptive
Item
woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last dose of protocol-specified therapy administration
boolean
C0700589 (UMLS CUI [1])
pregnant or breast feeding
Item
subject is pregnant or breast feeding, or planning to become pregnant within 6 months after the last dose of protocol-specified therapy administration
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
condom
Item
male subject with a pregnant partner who is not willing to use a condom during treatment and for an additional 6 months after the last dose of protocol-specified therapy administration
boolean
C3174747 (UMLS CUI [1])
subject has previously entered this study
Item
subject has previously entered this study
boolean
C2348568 (UMLS CUI [1])
study visits
Item
subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge
boolean
C0545082 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Disorder
Item
subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
boolean
C0012634 (UMLS CUI [1])
C1511481 (UMLS CUI [2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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