Table 5.
Frequency and classification of SAEs
| Total number of patients for safety analysis | 40 |
| Total exposure time (years) | 89.42 |
| Total number of SAEs, n (patient-years) | 59 (0.66) |
| Total number of patients with SAEs | 18 |
| Number of treatment-related SAEs/number of patients | 36/10 |
| Number of not treatment-related SAEs/number of patients | 23/13 |
| Number of infections (patient-years)/number of patients | 29 (0.32)/12 |
| Number of cases of meningococcal bacteraemia (patient-years) | 1 (0.01) |
| Seriousness of SAE | |
| Number of SAEs related to death (number of patients) | 7 (4) |
| Number of life-threatening SAEs (number of patients) | 8 (4) |
| Number of SAEs which required inpatient hospitalization or prolongation of existing hospitalization (number of patients) | 23 (8) |
| Number of SAEs related to persistent or significant disability/incapacity (number of patients) | 3 (2) |
| Number of congenital anomalies/birth defects (number of patients) | 0 (0) |
| Number of other IMEa (number of patients) | 4 (2) |
| SAE reported more than once, n (patient-years) | |
| Renal impairment | 5(0.06) |
| Device-related infection | 3(0.03) |
| Staphylococcal infection | 2(0.02) |
| Urinary tract infection | 2(0.02) |
| Infection | 2(0.02) |
| Respiratory syncytial virus bronchitis | 2(0.02) |
| Pulmonary haemorrhage | 2(0.02) |
| Enterocolitis | 2(0.02) |
| Pyrexia | 2(0.02) |
RS, respiratory syncytial; IME, important medical event.
aAn IME that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse drug experience when, based on medical judgement, it may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.