Table 2.
PCR-corrected ACPR in m-ITT population (Eurartesim pivotal trials - Plasmodium falciparum)18
| Study DM040010 |
Study DM040011 |
|||
|---|---|---|---|---|
| Eurartesim | AS+MQ | Eurartesim | A/L | |
| n=726 | n=361 | n=1027 | n=497 | |
| Patients excluded from the m-ITT population | 43 (5.6%) | 20 (5.3%) | 12 (1.2%) | 17 (3.3%) |
| PCR-corrected ACPR | ||||
| Available observations | 726a | 361a | 1027b | 497b |
| Number of patients cured (cure rate) | 704 (97.0%)a | 344 (95.3%)a | 952 (92.7%)b | 471 (94.8%)b |
| Between group comparison | ||||
| Difference | 1.7 | −2.1 | ||
| LL 97.5% CIc | −0.8 | −4.6 | ||
| Conclusiond | Non-inferiority | Non-inferiority | ||
| p-valuee | 0.161 | 0.128 | ||
ACPR: adequate clinical and parasitological response; AS+MQ: artesunate + mefloquine; A/L: artemether–lumefantrine; LL: lower limit; m-ITT: modified intent-to-treat (all randomized patients who received at least one dose of study treatment, excluding those lost to follow-up for unknown reasons).
Study DM040010: A Phase III, Randomised, Non-Inferiority Trial, to Assess the Efficacy and Safety of Dihydroartemisinin + Piperaquine Phosphate (DHA/PQP, Artekin) in Comparison with Artesunate + Mefloquine (AS+MQ) in Patients Affected by Acute, Uncomplicated Plasmodium falciparum Malaria.
Study DM040011: A Phase III, Randomised, Non-Inferiority Trial, to Assess the Efficacy and Safety of Dihydroartemisinin + Piperaquine Phosphate (DHA/PQP, Artekin) in Comparison with Artemether + Lumefantrine (A/L, Coartem) in Children with Uncomplicated Plasmodium falciparum Malaria.
a PCR-corrected ACPR on day 63.
b PCR-corrected ACPR on day 28.
c The one-sided CI for between group comparison was calculated using the normal approximation (Wald method).
d Non-inferiority was concluded if the lower limit of the one-sided 97.5% CI for the difference was above -5%.
e χ2 test for superiority (performed only when non-inferiority had been demonstrated).