Skip to main content

Table 3 Efficacy endpoint classification at day 28 and day 42, - PP / percent cured analysis

From: Efficacy of artesunate-amodiaquine and artemether-lumefantrine fixed-dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria among children aged six to 59 months in Nimba County, Liberia: an open-label randomized non-inferiority trial

Treatment outcome

Day 28

Day 42

PP population, N (%)

ASAQ

AL

ASAQ

AL

% cured analysis

N = 142

N = 126

N = 142

N = 126

ACPR

99 (69.7)

108 (85.7)

75 (52.8)

71 (56.3)

Success

ETF

0 (0)

1 (0.8)

0 (0)

1 (0.8)

Failure

LCF or LPF

     

- P. falciparum recrudescence

1 (0.7)

2 (1.6)

3 (2.1)

5 (4.0)

Failure

- P. falciparum re-infection

39 (27.5)

11 (8.7)

61 (43.0)

40 (31.7)

Excluded*

- undetermined or missing PCR

2 (1.4)

2 (1.6)

2 (1.4)

5 (4.0)

Excluded*

Non-P. falciparum malaria infection **

0 (0)

2 (1.6)

0 (0)

4 (3.2)

Excluded

No treatment outcome

     

- discontinued for SAE

1 (0.7)

0 (0)

1 (0.7)

0 (0)

Excluded

Patients analysed

     

Genotyping-adjusted analysis

N = 100

N = 111

N = 78

N = 77

 

Genotyping-unadjusted analysis

N = 141

N = 124

N = 141

N = 122

 
  1. mITT modified Intention To Treat, KM Kaplan-Meier, PP per protocol, ACPR Adequate Clinical and Parasitological Response, ETF Early Treatment Failure, LPF Late Parasitological Failure, LCF Late Clinical Failure, PCR Polymerase Chain Reaction, SAE Serious Adverse Event. * coded as Failure in genotyping-unadjusted analysis. ** Plasmodium malariae infections.