ID

43752

Description

Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials; ODM derived from: https://clinicaltrials.gov/show/NCT01423760

Link

https://clinicaltrials.gov/show/NCT01423760

Keywords

Versions (2)
  1. 3/6/16 3/6/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT01423760

English

Eligibility Non-Small Cell Lung Cancer NCT01423760

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
registration and treatment in a clinical trial with tecemotide (l blp25) under sponsorship of merck kgaa / emd serono / merck serono japan (feeder trial). [note, subjects who have been allocated to treatments not containing tecemotide (l blp25) in the feeder trial are eligible for this trial and will be followed-up for pd (if applicable) and survival.]
Description

therapy tecemotide

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3888078
end of treatment procedures have been performed in the feeder trial.
Description

therapy end

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444930
additional inclusion criteria also apply.
Description

inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the investigator. subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard.
Description

pregnancy; lactating; Contraception status; pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0086287
UMLS CUI [4]
C0032976
known hypersensitivity to any of the trial treatment ingredients (if applicable).
Description

hypersensitivity study drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
legal incapacity or limited legal capacity.
Description

Functional capacity

Data type

boolean

Alias
UMLS CUI [1]
C1998319
any other reason that, in the opinion of the investigator, precludes the subject from participating in the trial.
Description

undefined item

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0008972
additional exclusion criteria also apply.
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT01423760

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
therapy tecemotide
Item
registration and treatment in a clinical trial with tecemotide (l blp25) under sponsorship of merck kgaa / emd serono / merck serono japan (feeder trial). [note, subjects who have been allocated to treatments not containing tecemotide (l blp25) in the feeder trial are eligible for this trial and will be followed-up for pd (if applicable) and survival.]
boolean
C0087111 (UMLS CUI [1,1])
C3888078 (UMLS CUI [1,2])
therapy end
Item
end of treatment procedures have been performed in the feeder trial.
boolean
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
inclusion criteria
Item
additional inclusion criteria also apply.
boolean
C1512693 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy; lactating; Contraception status; pregnancy test
Item
pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the investigator. subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0086287 (UMLS CUI [3])
C0032976 (UMLS CUI [4])
hypersensitivity study drugs
Item
known hypersensitivity to any of the trial treatment ingredients (if applicable).
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Functional capacity
Item
legal incapacity or limited legal capacity.
boolean
C1998319 (UMLS CUI [1])
undefined item
Item
any other reason that, in the opinion of the investigator, precludes the subject from participating in the trial.
boolean
C2828389 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
exclusion criteria
Item
additional exclusion criteria also apply.
boolean
C0680251 (UMLS CUI [1])
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