Table 2.
Incidence of treatment-emergent adverse events and serious adverse events
|
Stage 1 g-HAT (n=69) |
Early stage 2 g-HAT (n=19) |
Late-stage 2 g-HAT (n=37) |
Total (n=125) |
||||||
|---|---|---|---|---|---|---|---|---|---|
| n (%) | Number of events | n (%) | Number of events | n (%) | Number of events | n (%) | Number of events | ||
| At least one adverse event | 61 (88%) | 317 | 18 (95%) | 75 | 37 (100%) | 195 | 116 (93%) | 587 | |
| At least one treatment-emergent adverse event | 61 (88%) | 316 | 18 (95%) | 75 | 37 (100%) | 195 | 116 (93%) | 586 | |
| At least one treatment-emergent adverse event during the treatment period | 60 (87%) | 294 | 18 (95%) | 69 | 35 (95%) | 151 | 113 (90%) | 514 | |
| At least one treatment-emergent adverse event after the treatment period | 17 (25%) | 22 | 4 (21%) | 6 | 18 (49%) | 44 | 39 (31%) | 72 | |
| At least one treatment-emergent adverse event leading to treatment discontinuation | 0 | 0 | 0 | 0 | 1 (3%) | 1 | 1 (1%) | 1 | |
| At least one treatment-emergent adverse event leading to permanent treatment discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| At least one mild or moderate treatment-emergent adverse event | 60 (87%) | 306 | 18 (95%) | 68 | 37 (100%) | 182 | 115 (92%) | 556 | |
| At least one severe treatment-emergent adverse event | 9 (13%) | 10 | 5 (26%) | 7 | 11 (30%) | 13 | 25 (20%) | 30 | |
| At least one treatment-emergent adverse event possibly related to treatment | 54 (78%) | 207 | 17 (90%) | 45 | 32 (86%) | 101 | 103 (82%) | 353 | |
| At least one serious adverse event | 5 (7%) | 6 | 2 (11%) | 3 | 4 (11%) | 8 | 11 (9%) | 17 | |
Data are from the complete 18-month timepoint of the intention-to-treat population (n=125). Causality was assessed by both the Investigator as planned in the protocol: a possibly-related adverse event was any event that was not considered as unrelated to the study treatment or for which no plausible alternative explanation existed. The funder of the study also assessed adverse event causality using this definition. The intensity of an adverse event was graded as mild (grade 1), moderate (grade 2), or severe (grade 3 was severe, grade 4 was life-threatening, and grade 5 was death). g-HAT=gambiense human African trypanosomiasis.