Table 4.
Safety Outcomes
| Event | Total (N=3170) | Active Cohort (n=2679) | Passive Cohort (n=491) | ||||
|---|---|---|---|---|---|---|---|
| na | IRb | na | IRb | na | IRb | ||
| Reason to consider event as serious | Death | 8 | 2.5 | 6 | 2.2 | 2 | 4.1 |
| Life-threatening | 6 | 1.9 | 6 | 2.2 | 0 | 0.0 | |
| Hospitalization | 61 | 19.2 | 39 | 14.6 | 22 | 44.8 | |
| Disability/incapacityc | 1 | 0.3 | 1 | 0.4 | 0 | 0.0 | |
| Any SAE during 28 days of follow-up | 76 | 24.0 | 52 | 19.4 | 24 | 48.9 | |
| SAE intensity | Moderate | 12 | 3.8 | 9 | 3.4 | 3 | 6.1 |
| Severe | 52 | 16.4 | 31 | 11.6 | 21 | 42.8 | |
| Life-threatening | 12 | 3.8 | 12 | 4.5 | 0 | 0 | |
| Number of persons who had SAE | 62 | 19.6 | 42 | 15.7 | 20 | 40.7 | |
| Specific SAE during 28 days of follow-up | Severe anemia | 1 | 0.3 | 1 | 0.4 | 0 | 0 |
| Lethargy | 1 | 0.3 | 0 | 0 | 1 | 2.0 | |
| Severe convulsions | 1 | 0.3 | 1 | 0.4 | 0 | 0 | |
| Severe somnolence | 1 | 0.3 | 1 | 0.4 | 0 | 0 | |
| Severe dizziness | 2 | 0.6 | 0 | 0 | 2 | 4.1 | |
| Spontaneous abortion | 1 | 0.3 | 1 | 0.4 | 0 | 0 | |
| Time of event occurrenced | During first 3 days | 903 | 284.9 | 564 | 210.5 | 339 | 690.4 |
| Between 4 and 7 days | 447 | 141.0 | 377 | 140.7 | 70 | 142.6 | |
| After 7 days | 1345 | 424.3 | 1188 | 443.4 | 157 | 319.8 | |
Notes: aIndicates the number of events; a patient could have one or more events at a time. bIndicates the incidence rate per 1000 (n/N). cOne case of rheumatoid arthritis. dNumbers may not add up to total number due to missing values.
Abbreviation: SAE, serious adverse event.