Table 2 Patient disposition (randomised set)
All patients | 800:640 (N = 148) | 800:960 (N = 151) | 800:1440 (N = 149) | Total (N = 448) | |
|---|---|---|---|---|---|
Treated | n (%) | 143 (96.6) | 148 (98.0) | 146 (98.0) | 437 (97.5) |
Completed | n (%) | 57 (38.5) | 56 (37.1) | 65 (43.6) | 178 (39.7) |
Premature study discontinuation | n (%) | 91 (61.5) | 95 (62.9) | 84 (56.4) | 270 (60.3) |
Primary reason for premature study discontinuation | |||||
Criteria met for established anti-malarial treatment | n (%) | 68 (45.9) | 79 (52.3) | 64 (43.0) | 211 (47.1) |
Study drug discontinued | n (%) | 0 | 4 (2.6) | 3 (2.0) | 7 (1.6) |
Withdrawal of consent | n (%) | 9 (6.1) | 3 (2.0) | 7 (4.7) | 19 (4.2) |
Investigator’s opinion | n (%) | 1 (0.7) | 1 (0.7) | 0 | 2 (0.4) |
Patient non-compliant | n (%) | 0 | 1 (0.7) | 0 | 1 (0.2) |
Adverse event | n (%) | 0 | 0 | 1 (0.7) | 1 (0.2) |
Lost to follow-up | n (%) | 5 (3.4) | 3 (2.0) | 3 (2.0) | 11 (2.5) |
Other | n (%) | 8 (5.4) | 4 (2.6) | 6 (4.0) | 18 (4.0) |