Clinical Trial Search

Primary: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) — 10.89; 10.83 Grams per deciliter (g/dL) — p=<.0001

Primary: Equivalence Analysis of Area Under the Serial FEV1-Time Effect Curve From Time 0 to 12 Hours (FEV1 Area Under Curve [AUC0-12]) on the First Day of Treatment — 3.637…

Primary: Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. — 442.4; 427.1 CD8+ cells count

Primary: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization) — 6.52; 0.04; 6.54; 0.03 μg/mL

Primary: Change of Patient Rated Pruritus Score — -1.61; -1.50 score on a scale

Primary: Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification — NA; 104.3; 106.7; 90.3 Weeks — p=<.0001

Primary: Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) — 473; 531; 640; 6 participants

Primary: Number of Participants With Implant-Related Serious Adverse Events — 0 Participants

Primary: Percentage of Participants Who Are Headache Pain Free — 28.2; 32.2; 15.3 percentage of participants — p=<0.001

Primary: Change in Body Weight (%) — -6.0; -1.5; -6.5; -1.7 Percentage change — p=< .0001

Primary: Mean Number of Returned Used Applicators Per Month (i.e in 30 Days) — 5.2; 5.7; 5.5; 5.8 Used gel applicators per month

Primary: Resolution of Cholestasis for Subjects Who Received Omegaven — 40; 10; 2 Participants

Primary: Change From Baseline in A1C at Week 24 — -0.07; -0.43; -0.48 percentage of A1C — p=<0.001

Primary: Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis — 0.11; 0.12 exacerbations per participant year

Primary: Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score — -10.01; -8.22; -9.90 units on a scale — p=0.9196