DDT COA #000009: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Qualified Clinical Outcome Assessments (COA)
Office of Oncologic Diseases (OOD)
Division of Oncology 2 (DO 2)
DDT COA Number
DDT COA #000009
Instrument Name
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Disease/Condition
Non-Small Cell Lung Cancer (NSCLC)
Concept of Interest
Symptom severity (cough, pain, dyspnea, fatigue, and appetite)
Context of Use
Adult patients (> 18 years) with Stage IIIB or IV NSCLC that are:
- Treatment naïve (i.e., treatment naïve to current chemotherapy and not having received chemotherapy for the past 6 months from study enrollment)
- Treated (i.e., received chemotherapy in the last 6 months and recovered from any prior treatment related toxicities/adverse events to CTCAE v4.03 grade 1 or better)
COA Type
PRO
Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium
Contact(s)
Sonya Eremenco
Date Accepted into CDER's COA Qualification Program
July 27, 2011
Qualification Date
April 4, 2018
Qualification Statement
Qualification Supporting Information
Review
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Full Qualification Package | 3/31/17 | FDA Response (Qualified) | 4/4/18 |
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