TABLE 5

Treatment failure by time point (ITT population)

Reason for failureNo. and % of patients in each treatment group
Day 28Day 42
Dispersible tablet (n = 199)Crushed tablet (n = 99)Dispersible tablet (n = 199)Crushed tablet (n = 99)
n%n%n%n%
Recrudescencea21.000.052.511.0
New P. falciparum infection126.044.03618.12121.2
Early treatment failure (ETF)10.500.010.600.0
Late treatment failure (LTF)147.044.04120.62222.2
Late clinical failure (LCF)31.522.0189.11212.1
Late parasitological failure (LPF)115.522.02311.61010.1
Lost to follow-up84.033.080.041.0
Repeated vomiting105.022.0105.022.0
Withdrawal before the time of analysis (day 28): any reason except lost to follow-up42.099.142.099.1
Day 28 visit missing and parasitemia at day 4210.511.0----
Adverse event00.000.000.011.0
Total no. of failures3819.01919.26432.23838.4
  • a For two patients (one for each group) with malaria recurrence, PCR analysis was not performed. Therefore, DSMB categorized these patients as treatment failures in the ITT population and missing in the PP population.