Table 3.
No of
events*
|
Excess risk (treated minus placebo) (95% CI)
|
|||
---|---|---|---|---|
Adverse event | Aspirin group | Placebo group | As prevalence per 100 people (%) | As incidence per 1000 person years |
Extracranial haemorrhage: | ||||
Fatal bleed | 13 | 15 | −0.01 (−0.07 to 0.05) | −0.03 (−0.20 to 0.14) |
Non-fatal major bleed (required transfusion or surgery) | 51 | 28 | 0.4 (0.1 to 0.6) | 1.2 (0.3 to 2.0) |
Haematemesis or melaena | 199 | 98 | 0.6 (0.4 to 0.8) | 1.6 (1.1 to 2.2) |
Any bleed | 1049 | 710 | 2.3 (1.7 to 2.8) | 7.0 (5.5 to 8.6) |
Upper abdominal discomfort, including heartburn | 689 | 621 | 1.6 (0.0 to 3.2) | 8.1 (0.7 to 15.4) |
Any symptom (any bleed and abdominal discomfort) | 1738 | 1331 | 3.9 (2.2 to 5.6) | 8.6 (1.1 to 16.1) |
Adverse effects sufficient to stop taking the tablets | 482 | 438 | 1.6 (0.7 to 2.5) | 5.5 (2.4 to 8.5) |
Numbers of participants in the aspirin and placebo groups of each trial were almost identical (see web table B).