SAE | Intervention arm n = 150 Number (%) | Control arm n = 142 Number (%) | OR (95%CI) | P value |
---|---|---|---|---|
Any SAE | 5 (3.3) | 3 (2.1) | 1.61 (0.38–6.86) | 0.72 (Fisher’s) |
Death | *4 (2.7) | 1 (0.7) | 3.89 (0.43–35.23) | 0.37 (Fisher’s) |
Prolonged hospitalization | 0 | 2 (1.4) | Cannot be computed | |
ICU admission | 1 (0.7) | 0 | Cannot be computed |