Analyses of Secondary Efficacy Endpoints Sample Clauses

Analyses of Secondary Efficacy Endpoints. Section 9.4.8.1 FACIT-Fatigue (Version 4) Added secondary objective to evaluate the effect of ALXN2050 on FACIT scores and added secondary endpoint of change in FACIT scores from baseline to Week 12 and EOT. To clarify objective and endpoint for FACIT
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Analyses of Secondary Efficacy Endpoints. ‌ The secondary efficacy endpoints are: • Number of patients who have RBC transfusion avoidance during 12 weeks of treatment with ALXN2050. Transfusion avoidance is defined as patients remaining transfusion-free and not requiring a transfusion through Week 12 as per protocol-specified guidelines (Section 6.8). • Number of RBC units transfused and transfusion instances during 12 weeks of treatment as compared with transfusion data prior to screening • Change in LDH level from baseline measurement at Week 12 • Change in absolute reticulocyte count and direct and total bilirubin from baseline measurement at Week 12 • Change in PNH RBC clone size and C3 fragment deposition on PNH RBCs from baseline measurement at Week 12. • Change in FACIT-Fatigue score from baseline to Week 12 and Week 160. Similar to Hgb measurements, descriptive statistics and graphic presentations for the numeric secondary endpoints listed above will also be provided. Summary statistics for RBC transfusion units received during 12 weeks of dosing will also be provided.
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Related to Analyses of Secondary Efficacy Endpoints

  • Dimensions Education Bachelor’s Degree in Computer Science, Information Systems, or other related field. Or equivalent work experience. A minimum of 3 years of IT work experience in supporting desktop software and hardware products and problem solving/troubleshooting.

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