Clinical Trial Search

Primary: Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo — -1.86; -2.47; -2.24; -2.09 units on a…

Primary: Physical Function — 19.5; 24.8 percentage of subjects

Primary: Calculated Blood Loss at 3rd Post Operative Day (POD) — 19.9; 15.9 ml/kg

Primary: Kaplan-Meier (K-M) Estimate for Overall Survival (OS) — 24.7; 14.8 Months — p=0.0009

Primary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 — 32.9; 64.1; 63.7 percentage of participants — p=< 0.001

Primary: Rate of Clinical Status Improvement — 27; 15 Participants — p=0.0372

Primary: Percentage of Participants With Local Reactions Within 10 Days After Vaccination — 7.0; 6.2; 3.9; 3.3 percentage of participants

Primary: Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment — -10.11; -9.66; -5.87 Score on a scale — p=<0.001

Primary: EORTC-QLQ-C30 Score — 51.2; 46.6 score on a scale — p=0.397

Primary: Annualized Number of Total Bleeds Within 48 h — 2.23; 1.86; 1.9 Bleeds

Primary: Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration — 43.8; 80; 80; 85.7 percentage of participants

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 88; 369; 414; 789 Participants

Primary: Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain…

Primary: Change in Quality of Life Measured Using the EPP-quality of Life Questionnaire (EPP-QoL). — 27.8; 59.7; 56.9 EPP-QoL score

Primary: Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response — 100; 91; 37 Participants — p=<0.0001