Clinical Trial Search

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period — 274 Participants

Primary: Extracellular Volume Fraction — 30.1; 25.3 percentage of myocardium

Primary: Safety: The Incidence of Treatment-related Adverse Events [AEs] — 0; 0; 0; 0 participants

Primary: Maximum Tolerated Dose (MTD) of Temsirolimus (Phase I) — 25 mg

Primary: Circulating LPS — 2.44; 1.86; 13.66; 10.00 EU/mL — p=>0.05

Primary: Lactulose:C13 Mannitol Excretion Ratio 8-24hrs. — 0.01; 0.02 Ratio — p=0.87

Primary: Number of Treatment Related Adverse Events — 0; 0; 0; 0 adverse events

Primary: Change in Semi-Quantitative Mycobacterial Culture Results From Baseline to Day 84. — 5; 5; 1; 1 Participants — p=0.072

Primary: Change in Right Ventricular Mass From Baseline — 3.9; -5.2 grams — p=0.028

Primary: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) — 65.4 percentage of participants

Primary: Number of Participants With at Least One Adverse Event (AE) Through Day 210 — 8; 8; 9; 6 Participants

Primary: Rate of Serious Adverse Events — 7 Participants — p=<0.0001

Primary: Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date — 0.18; 0.23 proportion of participants — p=0.02

Primary: Proportion of Participants With Eyelid Erythema — 117; 105 Participants — p=0.03

Primary: Overall Response Rate (ORR) at Day 28 — 19; 7; 13 Participants