Clinical Trial Search

Primary: Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) — 23; 26; 49; 8 participants

Primary: FEV1 AUC0-6 Response (Crossover Part of the Study) — 0.167; 0.252 liters — p=<0.0001

Primary: Pain Freedom (PF) — 13; 4; 5; 16 Participants — p=<0.001

Primary: Part A: Number of Participants With Adverse Events — 6; 11; 11; 15 Participants

Primary: Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. — 38.3; 35.7; 33.4 mm

Primary: Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score. — 0.13; -0.76 units on a scale — p=0.283

Primary: Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting — 85; 90 percent of participants

Primary: Serum Testosterone (T) — 0.43; 1.5; 3.7; 8.4 nmol/liter — p=<0.05

Primary: Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity — 15; 18 participants

Primary: Percent of Patients Estimated to be Progression-Free and Alive — 86; 76; 68 Percentage of Patients

Primary: Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. — 21; 11 Participants

Primary: Change in Weekly Alcohol Intake — -3.34; -1.21 standard drinks — p=0.0279

Primary: Number of Participants With Objective Response — 0; 1; 1; 1 participants

Primary: Number of Participants With Tobacco Abstinence — 14; 11 participants — p=.432

Primary: Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events — 5; 2; 3; 3 participants