Clinical Trial Search

Primary: Change From Baseline in Genant-modified Total Sharp Score (mTSS) — 7.00; 0 units on a scale — p=0.83

Primary: Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation. — 144.09; 298.52; 802.09; 139.50 pg/ml

Primary: Overall Survival — 108; 124 participants

Primary: Percentage of Participants With Treatment-Related Adverse Events — 8.2 percentage of participants

Primary: Percent Change From Baseline in Triglyceride Level at the Final Visit — -10.93; -22.65; -11.30 percent change — p=0.8760

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 106; 110; 109 participants

Primary: Ocular Health - Corneal Staining — 45; 53; 21; 13 Eyes

Primary: Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy — 28 percentage of participants

Primary: Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy — -0.72 percentage of change

Primary: Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate — 120.0; 60.4 ng/mL

Primary: Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline — -5 Units on a scale

Primary: Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. — 27 lesions

Primary: Number of Participants With Observed Local Erythema — 0 participants

Primary: Change From Baseline in the Weekly Itch Severity Score at Week 12 — -10.22; -8.80; -6.51 Units on a scale — p=<0.001

Primary: Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First. — 1.4; 3.3; 5.3 months — p=0.0030