Clinical Trial Search

Primary: Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS — -3.57; -2.31; -2.96; -1.48 score on a scale

Primary: Number of Participants Experiencing a Dose Limiting Toxicity — 1; 2; 1; 1 Participants

Primary: Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values — 8; 5 Participants

Primary: Maximum Plasma Concentration (Cmax) — 180.78; 529.91 pg/mL

Primary: Maximum Tolerated Dose (MTD) of Gemcitabine — 500 mg/m^2

Primary: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score — -1.18; -1.17 score on a scale

Primary: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) — 2.61; 2.60 Score on a scale

Primary: Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0 — 0 Participants

Primary: Objective Tumor Response — 12.2; 31.4 percentage of participants

Primary: Insulin Sensitivity — 10.16; 8.45; 9.47; 5.96 M Value (mg/kg/min) — p=<0.025

Primary: Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) — -6.46; -4.97; -4.62; -4.58 percent predicted — p=0.1095

Primary: Number of Participants Who Were Alive at 1 Year Transplant Overall Survival — 130 Participants

Primary: Persistently Elevated Blood Pressures 7 Days Postpartum — 10; 23 Participants — p=0.03

Primary: Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1 — 91…

Primary: Number of Participants With Adverse Events Related to Flortaucipir Administration — 0; 3; 0; 3 Participants