Table 2.
Number of subjects reported with AEs by study group
| Description | PvDBPII (10 µg) | PvDBPII (25 µg) | PvDBPII (50 µg) | Hepatitis B (20 µg) |
|---|---|---|---|---|
| AEs (N) | 14 | 15 | 19 | 20 |
| Solicited AEs | 1 (7.14) | 0 | 0 | 0 |
| Unsolicited AEs | 13 (92.86) | 15 (100) | 19 (100) | 20 (100) |
| - Lab abnormalities | 12 (92.31) | 15 (100) | 19 (100) | 20 (100) |
| - Clinical AE (rash) | 1 (7.69) | 0 | 0 | 0 |
| SAEs (n) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
| AE lost to follow-up (n)* | 0 (0.00) | 4 (26.67) | 0 (0.00) | 0 (0.00) |
AE adverse event, N, total number of AEs, n, number of events for each study group, SAE serious AE; % = (n/N)100
*All four AEs lost to follow-up were reported in subject R202