Competing risk events in antimalarial drug trials in uncomplicated Plasmodium falciparum malaria: a WorldWide Antimalarial Resistance Network individual participant data meta-analysis

Table 3 Absolute overestimation (%) in cumulative recrudescence estimates using K–M analysis compared to Cumulative Incidence Function

	N	Absolute overestimation^a	Observed proportion of recrudescence^b	Observed proportion of competing risk events^b
Day 28
AL	88	0.02% [IQR: 0.00–0.12%; Range: 0.00–2.54%]	2.1% [0.1–16.0%]	9.8% [0.0–51.4%]
ASAQ	21	0.03% [IQR: 0.00–0.10%; Range: 0.00–0.98%]	2.5% [0.3–12.8%]	10.2% [0.0–45.4%]
ASMQ	8	0.00% [IQR: 0.00–0.03%; Range: 0.00–0.08%]	1.9% [0.8–7.0%]	11.0% [6.3–14.0%]
DP	30	0.00% [IQR: 0.00–0.00%; Range: 0.00–0.16%]	1.3% [0.4–16.4%]	2.7% [0.0–36.8%]
Day 42
AL	48	0.25% [IQR: 0.03–0.65%; Range: 0.00–3.24%]	3.7% [0.6–18.0%]	21.6% [0.0–65.4%]
ASAQ	9	0.23% [IQR: 0.02–0.69%; Range: 0.00–2.24%]	3.3% [1.0–17.0%]	18.4% [2.3–65.2%]
ASMQ	8	0.25% [IQR: 0.12–0.50%; Range: 0.00–1.03%]	3.7% [1.4–11.3%]	25.3% [1.0–43.3%]
DP	21	0.00% [IQR: 0.00–0.19%; Range: 0.00–0.73%]	1.9% [0.8–16.4%]	7.1% [0.0–34.6%]
Day 63
AL	9	0.96% [IQR: 0.65–1.38%; Range: 0.012–3.42%]	3.7% [1.4–10.6%]	7.1% [0.0–34.6%]
ASAQ	2	0.18% [IQR: 0.09–0.27%; Range: 0.00–0.36%]	12.3%	18.5%
ASMQ	7	0.98% [IQR: 0.38–2.20%; Range: 0.21–3.59%]	4.1% [1.6–12.7%]	4.1% [1.6–12.7%]
DP	8	0.14% [IQR: 0.01–0.38%; Range: 0.00–0.89%]	2.2% [1.6–12.7%]	7.1% [3.4–30.0%]

N number of study sites with study sample size ≥ 25, AL artemether–lumefantrine, ASAQ artesunate–amodaiquine, DP dihydroartemisinin–piperaquine, ASMQ artesunate–mefloquine, IQR interquartile range
^aValues are median [Interquartile Range (IQR); Range] for \(\hat{F}_{KM} \left( t \right) - \hat{F}_{CIF} \left( t \right)\)
^bValues are median [Range]

ISSN: 1475-2875