TABLE 2

Summary of major protocol violations

CategoryDHA/PQP treatment group
Dispersible tablet (n = 199)Crushed tablet (n = 99)
Total no. of patients with major violations2615
% of patients with major violations13.115.2
Protocol violation, no. (%) of patients
    Repeated study drug vomiting10 (5.0)2 (2.0)
    Study drug noncompliance2 (1.0)0
    Presence of jaundice at screening1 (0.5)0
    Consent withdrawal3 (1.5)8 (8.0)
    Visit at day 28 not performed and malaria recurrence at day 421 (0.5)1 (1.0)
    Lost to follow-up at or before day 428 (4.0)3 (3.0)
    Moved away from the study site1 (0.5)0
    Left the hospital after first drug administration01 (1.0)