Clinical Trial Search

Primary: Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity — 14246.1; 5709.4; 11569.5; 26164.0 ng*h/mL

Primary: Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score — -21.03; -22.42 units on a scale — p=0.5587

Primary: Change From Baseline in Nasal Polyp Score at Week 16 — 0.20; -0.10; 0.14 score on scale — p=0.979

Primary: Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-Transplant — 155; 78 Participants

Primary: Percentage of Participants Who Survive With a Functional Graft at 24 Months — 98.2; 97.3 Percentage

Primary: Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 — 0; 16.1; 9.7; 51.6 percentage of participants

Primary: Weight Change (kg) From Baseline to Month 6, Main Effect of Time — -4.8 Kg — p=<.001

Primary: Lesion Healing — 107.47; 110.08; 112.41 hours

Primary: Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count — 65.47; 67.89; 55.51 percentage of lesion reduction

Primary: Responder — 16.7 percentage of responders

Primary: Mean Percent Change From Baseline in the Papules and Pustules Lesion Count — 68.18; 63.56; 50.72 percentage of lesion change

Primary: Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period — 120.6; NA weeks — p=0.0184

Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) — 824; 814 Participants

Primary: Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period — -4; -13 score on a scale

Primary: Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 — 8.0; 10.7; 8.5; 16.8 percentage of participants…