Table 4.
Most common adverse events (PSDS population)
| System organ class preferred term | Number (%) of subjects, N = 207 | Number of events | Rate/infusion, N = 1620a |
|---|---|---|---|
| Any adverse event | 100 (48.3) | 284 | 0.175 |
| Headache | 34 (16.4) | 53 | 0.033 |
| Nasopharyngitis | 12 (5.8) | 12 | 0.007 |
| Nausea | 10 (4.8) | 12 | 0.007 |
| Hemolysisb | 7 (3.4) | 7 | 0.004 |
| Hypertension | 6 (2.9) | 7 | 0.004 |
| Rash | 6 (2.9) | 6 | 0.004 |
| Vomiting | 6 (2.9) | 7 | 0.004 |
| Back pain | 5 (2.4) | 5 | 0.003 |
| Fall | 5 (2.4) | 5 | 0.003 |
| Fatigue | 5 (2.4) | 11 | 0.007 |
| Edema peripheral | 5 (2.4) | 5 | 0.003 |
Abbreviations: N, number of subjects; PSDS, pre‐randomization safety data set.
a
Number of infusions.
b
Two out of the seven hemolysis subjects met the laboratory criteria for hemolysis, both from non‐O blood groups.