Informed Consent | Informed Consent Patient's next of kin
Item
1. provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated/allowed by local regulations
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0421492 (UMLS CUI [2,2])
Age | Japanese
Item
2. aged at least 18 years. patients from japan aged at least 20 years
boolean
C0001779 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
Neoplasm EGFR T790M Mutation Negative | Biopsy EGFR gene mutation Test
Item
3. patients who have been considered ineligible for entry into the azd9291 aura3 registration trial as a result of their tumour not harbouring the t790m mutation, according to the cobas egfr test of a biopsy taken following the latest line of therapy, at a central testing lab participating in the d5160c00003 (aura3) study.
boolean
C0027651 (UMLS CUI [1,1])
C4329762 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C3266992 (UMLS CUI [2,2])
C0039593 (UMLS CUI [2,3])
Second line treatment | Second line treatment Planned
Item
4. patients who have undertaken or plan to undertake 2nd-line therapy after screen failure for the aura3 study.
boolean
C1710038 (UMLS CUI [1])
C1710038 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Therapeutic procedure
Item
1. treatment with any of the following:
boolean
C0087111 (UMLS CUI [1])
Prior Therapy | Systemic therapy Quantity Advanced disease
Item
prior treatment with more than one line of systemic treatment for advanced disease prior to failing screening assessments for aura3.
boolean
C1514463 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
Major surgery | Exception Vascular Access Device Placement
Item
major surgery (excluding placement of vascular access) within 4 weeks prior to failing screening assessments for aura3.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1519955 (UMLS CUI [2,2])
Palliative course of radiotherapy Radiation Field Limited | Exception Therapeutic radiology procedure Bone Marrow Percentage | Exception Radiation Field Wide
Item
palliative radiotherapy with a limited field of radiation within 1 week prior to enrolment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks prior to failing screening assessments for aura3..
boolean
C0475092 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1882536 (UMLS CUI [3,2])
C0332464 (UMLS CUI [3,3])
Compression of spinal cord | Metastatic malignant neoplasm to brain | Exception Asymptomatic Disease | Exception Stable status | Exception Steroids Absent
Item
2. spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to failing screening assessments for aura3..
boolean
C0037926 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C2936329 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Involvement with Clinical Trial Planning | Involvement with Completion of clinical trial | Staff Study Site
Item
3. involvement in the planning and conduct of the study (applies to astrazeneca staff or staff at the study site).
boolean
C1314939 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C2732579 (UMLS CUI [2,2])
C0851286 (UMLS CUI [3,1])
C2825164 (UMLS CUI [3,2])
Study Subject Participation Status Inappropriate | Protocol Compliance Unlikely
Item
4. judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
Study Subject Participation Status | Interventional Study
Item
5. patients who are known to be entering an interventional clinical study (blinded, randomized or open label clinical study) at the time of the enrolment into this study. however, inclusion in this study does not preclude participation in any other clinical study after enrolment. patients who participate in clinical studies after enrolment into this study will be followed up to the extent possible as permitted by the sponsor of that clinical study.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
EGFR T790M Mutation Test Result Invalid | EGFR T790M Mutation Test Result Unsuccessful
Item
6. patients with an invalid or unsuccessful t790m mutation test result during screening for aura3.
boolean
C3274192 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C3245471 (UMLS CUI [1,4])
C3274192 (UMLS CUI [2,1])
C0026882 (UMLS CUI [2,2])
C0456984 (UMLS CUI [2,3])
C1272705 (UMLS CUI [2,4])