Table 2.

Characteristics of adverse events.

	Number of Events 3166 (%)
Seriousness
Not Serious	562 (17.8)
Seriousness Criteria, of which	2604 (82.2)
Other Medically Important Condition	1293 (49.7)
Results in Death	703 (27.0)
Caused/Prolonged Hospitalisation	398 (15.3)
Life Threatening	179 (6.9)
Disabling	29 (1.1)
Congenital Anomaly	2 (0.1)
Outcome
Fatal	703 (22.2)
Not Recovered/Not Resolved	577 (18.2)
Recovered/Resolved	644 (20.3)
Recovering/Resolving	293 (9.3)
Recovered/Resolved With Sequelae	6 (0.2)
Unknown	943 (29.8)
Adverse Event Duration, Days, Mean (±SD)	4.16 (7.06)