Table 2. Summary of AEs in intent-to-treat population of patients in study of treatments for West Nile virus central nervous system disease, by treatment arm* .
| Characteristic | Omr-IgG-am, n = 37 | Polygam, n = 12 | Normal saline, n = 13 | Total, n = 62 |
|---|---|---|---|---|
| AEs | 514 | 106 | 118 | 738 |
| patients with an AE | 36 (97.3) | 11 (91.7) | 58 (93.5) | 58 (93.5) |
| AEs per patient |
14.28 |
9.64 |
10.73 |
12.72 |
| Relationship to treatment† | ||||
| Unrelated | 482 (93.8) | 99 (93.4) | 113 (95.8) | 694 (94) |
| Related | 29 (5.6) | 7 (6.6) | 5 (4.2) | 41 (5.6) |
| Not stated |
3 (0.6) |
0 |
0 |
3 (0.4) |
| Severity of AE† | ||||
| Mild | 226 (44.0) | 45 (42.5) | 61 (51.7) | 332 (45.0) |
| Moderate | 221 (43.0) | 34 (32.1) | 45 (38.1) | 300 (40.7) |
| Severe | 54 (10.5) | 13 (12.3) | 9 (7.6) | 76 (10.3) |
| Life-threatening | 13 (2.5) | 14 (13.2) | 3 (2.5) | 30 (4.1) |
*Values are no. (%) except as indicated. In comparing Omr-IgG-am with Polygam and Omr-IgG-am with normal saline, no significant differences were identified for characteristics listed in this table (all p values >0.05) except for mild severity Omr-IgG-am vs. Polygam (p<0.01). AE, adverse event. †As assessed by the investigator.