Table 5.
Distribution of serious arterial thrombotic events across exposure groups
| Drug | Serious arterial thrombotic events, n (%)* | ||||||
|---|---|---|---|---|---|---|---|
|
|
|||||||
| Death | Disability | Hospital stay | Life-threatening | Required intervention | Other§ | Total | |
| Omalizumab | 30 (16.3) | 10 (5.4) | 78 (42.4) | 1 (0.54) | 0 | 65 (35.3) | 184 |
| ICS | 8 (29) | 0 | 10 (35.7) | 2 (7.1) | 1 (3.6) | 7 (25) | 28 |
| LABA | 13 (27) | 3 (6.3) | 21 (44) | 2 (4.2) | 0 | 9 (19) | 48 |
| ICS-LABA | 88 (33.5) | 2 (0.76) | 79 (30) | 11 (4.2) | 1 (0.4) | 82 (31.2) | 263 |
| SABA | 7 (4.5) | 10 (6.5) | 72 (46.5) | 4 (2.6) | 4 (2.6) | 58 (37.4) | 155 |
| Oral SABA | 0 | 0 | 3 (60) | 1 (20) | 0 | 1 (20) | 5 |
| AMC | 77 (29) | 22 (8.3) | 119 (45) | 8 (3) | 1 (0.4) | 38 (14.3) | 265 |
| SABA-AMC | 7 (16.3) | 1 (2.3) | 18 (42) | 3 (7) | 0 | 14 (32.6) | 43 |
| Xanthines | 3 (43) | 0 | 2 (12) | 1 (6) | 0 | 11 (65) | 17 |
| Leukotriene modifiers | 6 (13) | 1 (2.2) | 19 (41.3) | 6 (13) | 0 | 14 (30.4) | 46 |
| Mast cell stabilizers | 0 | 0 | 0 | 0 | 0 | 1 (100) | 1 |
|
| |||||||
| Asthma drugs | 239 | 49 | 421 | 39 | 7 | 300 | 1055 |
| Other drugs | 19,756 | 7984 | 50,275 | 4314 | 816 | 46,379 | 129,524 |
|
| |||||||
| Total | 19,995 | 8033 | 50,696 | 4353 | 823 | 46,679 | 130,579 |
Notes:
*
Percentage of total serious events for the reported drug. Number of reports is mutually not exclusive, where one report could have more than one serious outcome classification;
§
unspecified serious outcomes are classified as “other”. There were only 73 reports for congenital anomalies, which were for nonasthma drugs.
Abbreviations: AMC, antimuscarinics; ICS, inhaled corticosteroids; LABA, long-acting beta-agonists; SABA, short-acting beta-agonists.