Clinical Trial Search

Primary: Change in Body Mass Index Z-score — 0.02; -0.08 16-wk change in BMI z-score

Primary: Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment — 22; 33.3; 1.5 Percentages of…

Primary: Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core Study — 1; 6; 12; 9 Participants…

Primary: Number of Participants With Any Adverse Event (AE), Drug-related AE, Grade 3 and Grade 4 AE, Grade 3 and 4 Drug-related AE , AE Leading to Discontinuation of Study Drug…

Primary: Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period — 61; 22…

Primary: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) — 4; 5; 7; 6 Participants

Primary: 9 Months In-stent Late Lumen Loss — 0.13; 0.13 mm — p=0.94

Primary: Feasibility (Total Uses) — 23.7 mean uses of the app

Primary: Score of the Barthel Index — 43 units on a scale

Primary: Mean Change in Total Lean Body Mass — 0.5; 2.3 kg — p=0.01

Primary: Change in Patient Activation in Care (PAM, a 13-item Scale) — 56.99; 56.77; 56.84; 58.74 units on a scale — p=<0.0001

Primary: Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15 — -1.0; 3.9 scores on a scale — p=0.0000001

Primary: Log10 PC20 to Methacholine After Visit 2 — 0.54; 0.48; 0.16; 0.53 log10 mg/mL — p=0.27

Primary: Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear — 53.5 percent correct

Primary: Local Control Rate — 1 Participants