ID

43752

Descrição

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

Palavras-chave

  1. 06/03/2016 06/03/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Non-Small Cell Lung Cancer NCT01423760

Eligibility Non-Small Cell Lung Cancer NCT01423760

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent.
Descrição

informed consent

Tipo de dados

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.]
Descrição

therapy tecemotide

Tipo de dados

boolean

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

therapy end

Tipo de dados

boolean

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

inclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Descrição

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.
Descrição

pregnancy; lactating; Contraception status; pregnancy test

Tipo de dados

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).
Descrição

hypersensitivity study drugs

Tipo de dados

boolean

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

Functional capacity

Tipo de dados

boolean

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

undefined item

Tipo de dados

boolean

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

exclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251

Similar models

Eligibility Non-Small Cell Lung Cancer NCT01423760

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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