Table 4. Comparative safety outcomes.
| Characteristic | Number of events (incidence per PYAR1) by treatment arm |
|||
|---|---|---|---|---|
| Control | Monthly SP | Daily TS | Monthly DP | |
| All grade 3-4 adverse events | 62 (1.214) | 77 (1.478) | 32 (0.659) | 35 (0.678)3 |
| Individual grade 3-4 adverse events2 | ||||
| Anemia | 36 (0.705) | 32 (0.631) | 10 (0.206) 4 | 15 (0.291) 3 |
| Elevated temperature | 22 (0.431) | 27 (0.532) | 10 (0.206) | 9 (0.174) 3 |
| Thrombocytopenia | 0 | 6 (0.118) | 0 | 3 (0.058) |
| Elevated aspartate aminotransferase | 2 (0.039) | 1 (0.020) | 2 (0.041) | 2 (0.039) |
| Malnutrition | 1 (0.020) | 1 (0.020) | 1 (0.021) | 2 (0.039) |
| Grade 3-4 events possibly related to study drugs | N/A | 0 | 3 (0.062) | 5 (0.097) |
| All serious adverse events | 21 (0.411) | 23 (0.453) | 16 (0.330) | 10 (0.194) |
1
PYAR = person-year at risk
2
Only includes those with at least 5 total events
3
p-value< 0.05 compared to control group
4
p-value< 0.01 compared to control group