Table 5.
Summary of adverse events (TTS, N = 62)
| Patients (n %) (N = 62) |
Infusions (n %) (N = 766) |
AEs Total (per infusion) |
|
|---|---|---|---|
| TEAEs | 51 (82.3) | 205 (26.8) | 343 (0.45) |
| Drug-related TEAEs | 33 (53.2) | 105 (13.7) | 148 (0.19) |
| TAAEs | 39 (62.9) | 119 (15.5) | 170 (0.22) |
| ≤4 mL/kg/h (439 infusions) | 31 (50.0) | 77 (17.5) | 116 (0.26) |
| >4 to ≤6 mL/kg/h (162 infusions) | 14 (22.6) | 19 (11.7) | 24 (0.15) |
| >6 mL/kg/h (165 infusions) | 12 (19.4) | 23 (13.9) | 30 (0.18) |
| SAEs | 15 (24.2) | 19 (2.5) | 20 (0.03) |
| Drug-related SAEs | 4 (6.5) | 4 (0.005) | 4 (0.005) |
| Discontinuation of study drug due to AE | 4 (6.5) | 4 (0.005) | 5 (0.007) |
| Interruption of study drug due to AE | 4 (6.5) | 5 (0.007) | 7 (0.009) |
| Flow rate decrease or no increase due to AE | 8 (12.9) | 10 (0.03) | 11 (0.01) |
AE adverse event, SAE serious adverse event, TAAE temporally associated adverse event, TEAE treatment-emergent adverse event, TTS total treated set