Clinical Trial Search

Primary: Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8 — 67.96 percentage of participants

Primary: Percentage of Participants With Febrile Neutropenia (FN) — 8; 8; 15; 9 percentage of participants

Primary: Anemia-response — 8; 6 Participants

Primary: Number of Participants With Clinically Significant Events — 4; 3; 6; 5 participants

Primary: Response to Rituximab — 0; 2; 9 participants

Primary: The Percentage of Participants Who Exhibit a Hematopoietic Response — 68.9; 61.7; 65.5; 66.7 Percentage of participants — p=>0.41

Primary: Hemoglobin Levels at 12-weeks. Marginal Means (95% CI). — 123; 116; 121; 116 g/L — p=<0.05

Primary: Percentage of Participants With Response to Treatment — 50.8 percentage of participants

Primary: Change in Left Ventricular End-diastolic Volume — -6; -4 mL

Primary: Haemoglobin Level — 88.3; 89.2; 88.4; 89.6 g/L — p=<0.05

Primary: Hemoglobin Concentrations — 11.5; 12.2 g/dL — p=0.02

Primary: The Incidence of Early Onset Sepsis in VLBW Infants With AOP. — 18; 34; 7; 42 Participants

Primary: Median Time to First Cardiovascular Event — NA; NA days — p=0.2036

Primary: Number of Patients Demonstrating Overall Hematologic Improvement (HI) — 6; 5; 7 Participants

Primary: Best Overall Response Rate as Determined by International Working Group Criteria — 28.6 percentage of patients with CR, PR or CI

Primary: Percentage of Participants With Early Treatment Response: Day 28 to 42 — 52.4; 56.5; 53.8 percentage of participants

Primary: Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response — 114; 109; 106; 50 Participants — p=0.39

Primary: Total Hospital Costs — 23,667; 17,100 Dollars

Primary: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 — 0.69; 0.10 g/m^2 — p=0.8811

Primary: Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) — 14.58 g/L — p=<0.0001

Primary: Percent Hb 10-12 g/dL — 61.9; 72.5 Percent

Primary: Clinical Response: Hematological Improvement - Erythroid (HI-E) — 0; 0 participants

Primary: Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. — 6; 22 participants

Primary: Change From Baseline in Hemoglobin at Day 28 — 1.3 g/dL

Primary: Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16 — 5; 10 particpants — p=0.248

Primary: Percentage of Participants Who Achieved RBC-Transfusion Independence — 17.3; 16.7 percentage of participants — p=1.000

Primary: Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period — 59.2; 36.1 percentage of participants — p=0.008

Primary: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 — 42; 60 Participants — p=0.0143

Primary: Proportion of Patients Free of Transfusion at 4 Months — 0.459; 0.714 Proportion of patients

Primary: Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment — 53; 61 Participants