Clinical Trial Search

Primary: Part 1: Progression Free Survival (PFS) by BIRC in Combo 450 Group as Compared to Vemurafenib Group — 14.9; 7.3 Months

Primary: Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52) — -0.04; 0.02 Grams per deciliter (g/dL)

Primary: Change From Baseline in Blood Hemoglobin Level (g/L) — 18.33; 18.52 g/L — p=0.0032

Primary: Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period — -2.48; -3.69; -3.86; -4.20 migraine days per month — p=<.0001

Primary: Number of Participants Experiencing Preterm Births or Stillbirths — 36; 36 Participants

Primary: Change in Body Weight (%) — -16.5; -5.8; -17.6; -6.1 Percentage — p=<.0001

Primary: Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants — 873; 451; 59; 25 IR/100 patient-years

Primary: Number of Participants Experiencing Adverse Events — 0; 0; 3; 3 Participants

Primary: Mean Change From Baseline in the Monthly (28 Days) Average Number of Migraine Days During the 12-week Period After the First Dose of Investigational Medicinal Product…

Primary: Percent Change in Left Ventricular Thrombus (LVT) Size — -61.45; -65.08 percentage of change

Primary: SVd/Vd Arm: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC) — 13.93; 9.46 Months — p=0.0075

Primary: Smoking Abstinence at 12 Months — 30; 33; 2 Participants

Primary: Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) — -11.7; -17.6; -17.5 units on a scale — p=0.0038

Primary: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. — 197; 312…

Primary: Change in HbA1c From Baseline to Week 24 — -0.85; -0.37 percentage of glycated hemoglobin — p=<0.0001