Clinical Trial Search

Primary: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) — 8.2; 2.3; 9.7; 2.5 change in percentage

Primary: Time to Progression — 7.0; 9.8 Months — p=<0.0001

Primary: Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period — 15.8; 67.5 percentage of participants — p=< 0.001

Primary: Percentage of Participants Surviving at One and Four Years After Liver Transplant — 85; 77 percentage of participants

Primary: Number of Participants With Effectiveness and Safety Success — 30; 41 participants

Primary: Major Adverse Event (MAE) — 5.4 percentage of participants

Primary: Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)…

Primary: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). — 38; 47 % success at 24 months — p=0.01

Primary: Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days). — -0.74; -0.69 units on a scale…

Primary: Overall Survival (OS) — 12.06; 13.50 months — p=0.0032

Primary: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month — 12.0; 13.0 units on a scale — p=0.49

Primary: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. — 0.315; 0.401 Liter — p=0.0110

Primary: Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18…

Primary: Change From Baseline in HbA1c After 24 Weeks — 0.07; -0.58 Percentage — p=<0.0001

Primary: Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L — 9; 15; 10 participants — p=0.26