Informatie:
Fout:
ID
35149
Beschrijving
Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings; ODM derived from: https://clinicaltrials.gov/show/NCT02440854
Link
https://clinicaltrials.gov/show/NCT02440854
Trefwoorden
Versies (1)
- 19-02-19 19-02-19 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
19 februari 2019
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02440854
Eligibility Carcinoma, Non-Small-Cell Lung NCT02440854
- StudyEvent: Eligibility
Similar models
Eligibility Carcinoma, Non-Small-Cell Lung NCT02440854
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Adult | Outpatients | Age
Item
adult outpatients (18 years and older) of either gender;
boolean
C0001675 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0029921 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | EGFR Activating Mutation
Item
histologically or cytologically confirmed locally advanced or metastatic (iiib/iv) nsclc of any histological type with activating egfr mutation(s) according to local laboratory egfr testing;
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C2984891 (UMLS CUI [3])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C2984891 (UMLS CUI [3])
Epidermal growth factor receptor inhibitor Absent
Item
egfr- tyrosine kinase inhibitor (tki) naive patients;
boolean
C1443775 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Afatinib Therapy prescribed
Item
patients for whom the decision to prescribe therapy with afatinib (giotrif®) according to the locally approved product's summary of product characteristics (smpc) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of afatinib is clearly separated from the physicians decision to include the patient in the current study;
boolean
C2987648 (UMLS CUI [1,1])
C2114399 (UMLS CUI [1,2])
C2114399 (UMLS CUI [1,2])
Informed Consent | Protocol Compliance
Item
patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0525058 (UMLS CUI [2])
Afatinib | Therapeutic procedure Initiation Before Enrollment
Item
patients who have initiated treatment with afatinib more than 7 days prior to their enrolment into the study;
boolean
C2987648 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C1516879 (UMLS CUI [2,4])
C0087111 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C1516879 (UMLS CUI [2,4])
Medical contraindication Investigational New Drugs
Item
patients that meet any of the contraindications to the administration of the study drug according to the approved smpc;
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
Investigational New Drugs
Item
receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with afatinib
boolean
C0013230 (UMLS CUI [1])