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| Number of patients with discrepancy in SAEs | |||
| Control (266) | Experimental (267) | Total (533) | |
| Patients with additional SAEs recorded in original data | 13 | 7 | 20 |
| Patients with 1 additional event Patients with 2 additional events | 7 6 | 4 3 | 11 9 |
| Patients with additional SAEs recorded in SDV data | 20 | 13 | 33 |
| Patients with 1 additional event Patients with 2 additional events | 19 1 | 11 2 | 30 3 |
| Total patients | 33 | 20 | 53 |
