Table 4. Summary of SAEs in intent-to-treat population 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 |
|---|---|---|---|---|
| SAEs | 29 | 25 | 9 | 63 |
| Patients with an SAE | 19 (51.4) | 7 (58.3) | 3 (23.1) | 29 (46.8) |
| SAEs per patient |
1.53 |
3.57 |
3.0 |
2.17 |
| Relationship to treatment† | ||||
| Unrelated | 27 (93.1) | 24 (96.0) | 7 (77.8) | 58 (92.1) |
| Related |
2 (6.9) |
1 (4.0) |
2 (22.2) |
5 (7.9) |
| Severity† | ||||
| Mild | 1 (3.4) | 0 | 0 | 1 (1.6) |
| Moderate | 4 (13.8) | 3 (12.0) | 0 | 7 (11.1) |
| Severe | 9 (31.0) | 8 (32.0) | 4 (44.4) | 21 (33.3) |
| Life-threatening | 11 (37.9) | 11 (44.0) | 4 (44.4) | 26 (41.3) |
| Death | 4 (13.8) | 3 (12.0) | 1 (11.1) | 8 (12.7) |
*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). SAE, serious adverse event. †As assessed by the investigator.