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Table 3 Primary and secondary endpoints

From: Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia

End point Arm A: 20 ml/kg (N = 82) Arm B: 30 ml/kg (N = 78) Risk ratio (95% CI) Pvalue
Time to correction of severe anemia (by 24 hours) - number (%) 61 (74) 70 (90) 1.54a (1.09,2.18) 0.01
Children meeting the criteria for additional transfusion - number (%) 12 (15) 4(5) 0.35 (0.12, 1.04) 0.06
SAE – number (%) 6 (7) 2 (3) 0.35 (0.07, 1.68) 0.28
Died before 48 hours – number (%) 4 (5) 0 (0)   0.12
Died before 28 days post-admission – number (%) 6 (7) 1 (1) 0.18 (0.02, 1.42) 0.12
Severe anemia or mortality at 28 days – number/total nb (%) 9/76 (12) 4/72 (6) 0.47 (0.15, 1.46) 0.25
  1. acause specific hazard ratio for correction of severe anemia before death (results similar using competing risks sub-distribution hazard, not shown); bdenominator excludes children who were alive at 28 days but in whom hemoglobin was not measured. CI, confidence interval; SAE, serious adverse event.