The efficacy and safety of a new fixed-dose combination of amodiaquine and artesunate in young African children with acute uncomplicated Plasmodium falciparum

Table 3 PCR-corrected cure rates on all predefined analysis datasets

Data set	AS/AQ	AS+AQ	Difference (95% CI) AS+AQ – AS/AQ
PP dataset	92.1% (315/342)	92.1% (313/340)	0.0% (-4.0%, 4.1%)
Modified PP dataset ¹	95.7% (315/329)	96.0% (313/326)	0.3% (-2.8%, 3.3%)
Full dataset (ITT) ²	85.3% (320/375)	85.9% (322/375)	0.5% (-4.5%, 5.6%)

1. The modified PP dataset excluded patients vomiting/spitting out study drug in addition to patients already excluded from the PP dataset
2. Patient withdrawals due to vomiting/spitting out study drug, refusal to take study drug, loss to follow up, patients taking anti-malarial drugs during follow up, etc., were counted as failures for analysis purposes

ISSN: 1475-2875