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])
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])