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  4. DDT COA #000009: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
  1. Development & Approval Process | Drugs

DDT COA #000009: Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

Qualified Clinical Outcome Assessments (COA)
Office of Hematology and Oncology Products (OHOP)
Division of Oncology Products 2 (DOP 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)
Stephen Coons

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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