Table 1.
Characteristics | Reported cases (n = 35) |
---|---|
Sex ratio (M/F) | 1.5 |
Age (median [minimum, maximum]) | 51 [13,79] |
Reporting region (n, %) | |
North America | 13 (37.1%) |
Europe | 9 (25.7%) |
Asia | 7 (20.0%) |
Latin America | 6 (17.1%) |
Seriousness criterion (n, %)a | |
Death | 6 (17.1%) |
Life threatening | 9 (25.7%) |
Disabling/incapacitating | 2 (5.7%) |
Hospitalization | 16 (45.7%) |
Other important condition | 18 (51.4%) |
System organ class [SOC] (n, %) b | |
Nervous system disorders | 10 (28.6%) |
Injury, poisoning, procedural complications | 9 (25.7%) |
General disorders and administration site conditions | 8 (22.9%) |
Investigations | 7 (20.0%) |
Gastrointestinal disorders | 7 (20.0%) |
Respiratory, thoracic, mediastinal disorders | 7 (10.4%) |
Infections and infestations | 6 (17.1%) |
Skin and subcutaneous tissue disorders | 4 (11.4%) |
Psychiatric disorders | 4 (11.4%) |
Metabolism and nutrition disorders | 3 (8.6%) |
Cardiac disorders | 3 (8.6%) |
Eye disorders | 2 (5.7%) |
Ear and labyrinth disorders | 2 (5.7%) |
Musculoskeletal, connectives tissues disorders | 2 (5.7%) |
Vascular disorders | 1 (2.9%) |
Social circumstances | 1 (2.9%) |
Each case can correspond to multiple seriousness criteria.
Each case can correspond to 1 or more SOCs.