TriangleNCT03521154 · MORE INFO
Limitations, agreements, and source contact
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- certain Agreement
- pi Sponsor Employee
- false
- restrictive Agreement
- false
- limitations And Caveats
- description
- As per CSP Section 7.2, patient monitoring during treatment with open-label osimertinib is monitored by the investigator per local clinical guidance. Serious AEs and AESIs are reported in the eCRF but were not analyzed/tabulated at the time of primary analysis. Safety assessments are to be performed as per local clinical practice and not collected as part of study data capture in line with the protocol.
- point Of Contact
- information.center@astrazeneca.com
- organization
- AstraZeneca Clinical Study Information Center
- phone
- 1-877-240-9479
- title
- Global Clinical Lead
Complete source fields
- certain Agreement
- pi Sponsor Employee
- false
- restrictive Agreement
- false
- limitations And Caveats
- description
- As per CSP Section 7.2, patient monitoring during treatment with open-label osimertinib is monitored by the investigator per local clinical guidance. Serious AEs and AESIs are reported in the eCRF but were not analyzed/tabulated at the time of primary analysis. Safety assessments are to be performed as per local clinical practice and not collected as part of study data capture in line with the protocol.
- point Of Contact
- information.center@astrazeneca.com
- organization
- AstraZeneca Clinical Study Information Center
- phone
- 1-877-240-9479
- title
- Global Clinical Lead
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice