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Table 2 Absolute overestimation in cumulative recrudescence by Kaplan-Meier (K-M) method compared to Cumulative Incidence Function (CIF) in simulation study I (n = 500 subjects)

From: Evaluating antimalarial efficacy in single-armed and comparative drug trials using competing risk survival analysis: a simulation study

 

Median absolute overestimation [IQR; Range]

5% recrudescence

Observed proportion of new infectionsa

Day 28

Day 42

Day 63

  < 10% NI

3.8% [1.0–6.6]

0.00% [0.00–0.00; Range:0.00–0.01]

0.02% [0.01–0.02; Range:0.00–0.06]

0.06% [0.05–0.07; Range:0.01–0.16]

 10–20% NI

17.0% [12.8–19.8]

0.00% [0.00–0.01; Range:0.00–0.02]

0.08% [0.07–0.10; Range:0.01–0.22]

0.31% [0.26–0.36; Range:0.13–0.55]

 20–40% NI

31.2% [25.0–37.8]

0.01% [0.00–0.01; Range:0.00–0.04]

0.18% [0.14–0.22; Range:0.04–0.42]

0.63% [0.54–0.73; Range:0.28–1.20]

 40 + % NI

43.0% [40.0–50.0]

0.01% [0.01–0.02; Range:0.00–0.06]

0.28% [0.23–0.34; Range:0.09–0.60]

0.94% [0.82–1.09; Range:0.32–1.75]

10% recrudescence

  < 10% NI

3.6% [1.2–6.2]

0.00% [0.00–0.00; Range:0.00–0.02]

0.03% [0.02–0.04; Range:0.00–0.11]

0.12% [0.10–0.15; Range:0.03–0.27]

 10–20% NI

16.4% [10.8–19.8]

0.01% [0.00–0.01; Range:0.00–0.05]

0.17% [0.14–0.21; Range:0.05–0.36]

0.60% [0.53–0.68; Range:0.26–0.96]

 20–40% NI

30.0% [24.4–36.2]

0.02% [0.01–0.02; Range:0.00–0.07]

0.36% [0.31–0.42; Range:0.13–0.89]

1.22% [1.09–1.37; Range:0.69–2.04]

 40 + % NI

42.0% [40.0–48.0]

0.03% [0.02–0.04; Range:0.00–0.08]

0.56% [0.48–0.65; Range:0.28–1.07]

1.90% [1.69–2.11; Range:1.18–3.13]

15% recrudescence

  < 10% NI

3.4% [1.0–6.2]

0.00% [0.00–0.00; Range:0.00–0.02]

0.05% [0.03–0.07; Range:0.00–0.16]

0.18% [0.14–0.22; Range:0.05–0.46]

 10–20% NI

16.0% [10.0–19.8]

0.01% [0.01–0.02; Range:0.00–0.06]

0.26% [0.22–0.31; Range:0.10–0.54]

0.92% [0.80–1.03; Range:0.46–1.50]

 20–40% NI

28.8% [23.0–36.6]

0.02% [0.02–0.03; Range:0.00–0.08]

0.54% [0.46–0.62; Range:0.25–1.02]

1.81% [1.64–2.01; Range:1.11–3.03]

 40 + % NI

41.0% [40.0–45.8]

0.04% [0.03–0.06; Range:0.00–0.14]

0.88% [0.77–1.00; Range:0.44–1.60]

2.91% [2.64–3.18; Range:1.69–4.30]

  1. aValues presented are median [Range]; NI = New infections