| Group 1 | Group 2 | ||||||
---|---|---|---|---|---|---|---|---|
SAV001 (n = 13) | Placebo (n = 4) | SAV001 + A (n = 12) | Placebo + A (n = 4) | |||||
n (%) | Number of AEsa | n (%) | Number of AEsa | n (%) | Number of AEsa | n (%) | Number of AEsa | |
Any AE | 9 (69.2) | 17 | 2 (50.0) | 2 | 9 (75.0) | 30 | 4 (100.0) | 13 |
Any serious AE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AE by maximum intensityb | ||||||||
 Mild | 6 (46.2) | 12 | 2 (50.0) | 2 | 6 (50.0) | 23 | 3 (75.0) | 12 |
 Moderate | 2 (15.4) | 4 | 0 | 0 | 3 (25.0) | 7 | 1 (25.0) | 1 |
 Severe | 1 (7.7) | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
 Potentially life threatening | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AE by relationshipc | ||||||||
 Not related | 6 (46.2) | 13 | 1 (25.0) | 1 | 6 (50.0) | 24 | 2 (50.0) | 11 |
 Unlikely | 2 (15.4) | 3 | 1 (25.0) | 1 | 2 (16.7) | 5 | 1 (25.0) | 1 |
 Possible | 1 (7.7) | 1 | 0 | 0 | 0 | 0 | 1 (25.0) | 1 |
 Probable | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
 Definite | 0 | 0 | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |