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

Table 4 Study sites where cumulative failure estimates exceeded 10% and 5% using K–M approach

Study (site)	N	Number of events (RC/NI/IND)	Day	Drug	\(\hat{F}_{KM} \left( t \right)\) estimate of recrudescence [95% confidence interval]	\(\hat{F}_{CIF} \left( t \right)\) estimate of recrudescence [95% confidence interval]
10% threshold^a
Nikiema-2010 (Burkina Faso, Gourcy)^b	144	12/28/3	28	AL	10.3 [4.8–15.8]	9.4 [4.3–14.5]
The 4ABC Trial (Burkina Faso, Nanoro) [18]	294	24/142/9	28	AL	11.1 [6.8–15.4]	8.6 [5.3–11.8]
Sirima-2015 (Burkina Faso, Balonghin) [21]	66	31/5/0	63	ASMQ	11.5 [7.2–15.9]	8.1 [1.2–14.9]
5% threshold^a
Yeka-2008 (Uganda, Kanungu) [45]	199	9/49/6	42	AL	5.2 [1.9–8.5]	4.6 [1.7–7.6]
Sirima-2015 (Tanzania, Korogwe) [21]	27	1/3/2	63	AL	5.0 [0.0–14.6]	4.3 [0.0–12.9]
Schramm-2013 (Liberia, Nimba) [46]	145	7/45/6	42	AL	5.6 [1.5–9.7]	5.0 [1.4–8.6]
Agrawal-2013 (Kenya, Siaya) [47]	136	5/48/12	42	AL	5.2 [0.5–10.0]	4.2 [0.6–7.8]
Karunajeewa-2008 (PNG, Madang) [48]	54	2/20/0	42	AL	5.9 [0.0–14.3]	4.7 [0.0–11.3]
Sirima-2015 (Kenya, Kisumu) [21]	99	4/23/9	63	ASMQ	6.1 [0.1–12.0]	4.8 [0.2–9.4]
Sirima-2015 (Burkina Faso, Balonghin) [21]	128	5/58/1	63	AL	5.4 [0.7–10.2]	4.0 [0.6–7.5]
Bukirwa-2006 (Uganda, Tororo) [49]	204	10/89/2	28	AL	6.6 [2.6–10.7]	4.9 [2.0–8.0]
Sirima-2015 (Kenya, Ahero) [21]	73	3/28/10	63	ASMQ	7.8 [0.0–16.7]	4.7[0.0–10.0]

N study sample size, RC recrudescence, NI new infection, IND indeterminate outcomes, \(\hat{F}_{KM} \left( t \right)\) cumulative failure estimates derived using 1 minus Kaplan–Meier method, \(\hat{F}_{CIF} \left( t \right)\) cumulative failure estimates derived using Cumulative Incidence Function, AL artemether–lumefantrine, ASMQ artesunate–mefloquine
^a The 10% threshold is used by the WHO for determining whether the current regimen should be continued to be used as a first line therapy and 5% threshold is used for introducing a new regimen as a first line treatment [50]
^b Unpublished study