Table 2.
Patient disposition from studies A0661120 (India), A0661126 (Colombia/Suriname), and A0661154 (Colombia/India)
| India (A0661120) | AZCQ 1 g | AZCQ 500 mg | SPCQ |
|---|---|---|---|
| Treated | 83 | 67 | 80 |
| Completed | 59 (71%) | 38 (57%) | 70 (88%) |
| Discontinued | 24 (29%) | 29 (43%) | 10 (13%) |
| Reason for discontinuation | |||
| Lack of efficacy | 14 (17%) | 21 (31%) | 3 (4%) |
| Lost to follow-up | 7 (8%) | 7 (10%) | 3 (4%) |
| AE | 3 (4%) | 0 | 1 (1%) |
| Others | 0 | 1 (2%) | 3 (4%) |
| PPP population at Day 28 | 73 (88%) | 59 (88%) | 72 (90%) |
|
| |||
| Colombia/Suriname (A0661126) | AZCQ 1 g | AZCQ 500 mg | AP |
|
| |||
| Treated | 114 | 14 | 116 |
| Completed | 59 (52%) | 3 (21%) | 108 (93%) |
| Discontinued | 55 (48%) | 11 (79%) | 8 (7%) |
| Reason for discontinuation | |||
| Lack of efficacy | 37 (33%) | 8 (57%) | 0 |
| Lost to follow-up | 0 | 1 (7%) | 4 (3%) |
| AE | 4 (4%) | 0 | 1 (1%) |
| Others | 13 (11%) | 2 (14%) | 3 (3%) |
| PPP population at Day 28 | 112 (98%) | 11 (79%) | 113 (97%) |
|
| |||
| Colombia/India (A0661154) | AZCQ 2 g | ||
|
| |||
| Treated | 110 | ||
| Completed | 103 (94%) | ||
| Discontinued | 7 (6%) | ||
| Reason for discontinuation | |||
| Lack of efficacy | 4 (4%) | ||
| Lost to follow-up | 0 | ||
| AE | 0 | ||
| Others | 3 (3%) | ||
| PPP population at Day 28 | 107 (97%) | ||
Note: Values are n unless otherwise noted.
Abbreviations: AE, adverse event; AP, atovaquone–proguanil; AZCQ, azithromycin–chloroquine; PPP, parasitologic per protocol; SPCQ, chloroquine plus sulfadoxine–pyrimethamine.