Table 7. Safety summary.
| AmBisome + SSG | AmBisome + Miltefosine | Miltefosine | |
|---|---|---|---|
| Number of patients | 51 | 49 | 51 |
| SAE, n (%) | 2 (4) | 2 (4) | 0 (0) |
| SAE related to study drug, n (%) | 1 (2) | 1 (2) | 0 (0) |
| Deaths, n (%) | 1 (2) | 1 (2) | 0 (0) |
| TEAE, n (%) | 41 (80) | 44 (90) | 46 (90) |
| TEADR, n (%) | 37 (73) | 38 (78) | 40 (78) |
| Treatment stopped due to AE | 0 (0) | 2* (4) | 1 (2) |
| AE during AmBisome infusion | 11 (22) | 9 (18) | - |
| Vomited any scheduled dose, n (%) | - | 10 (20) | 11 (22) |
| Repeatedly vomited the same scheduled dose | - | 1 (2) | 2 (4) |
| Vomited more than one scheduled dose | - | 1 (2) | 5 (10) |
*Only one of these received rescue and is shown as such in the flowchart.
TEAE: Treatment Emergent Adverse Event; TEADR: Treatment Emergent Adverse Drug Reaction