Worsening of mRS once a haemorrhagic event has taken place
| Population | Covariate | No bleeding | Any bleeding | OR (95% CI) |
|---|---|---|---|---|
| Minor stroke | ||||
| Analysis 1 | 197/3280 (6.0%) | 10/43 (23.3%) | 4.29 (2.03 to 9.03) | |
| Analysis 2 | 197/3656 (5.4%) | 10/69 (14.5%) | 2.77 (1.38 to 5.55) | |
| Analysis 3 | 573/3656 (15.7%) | 36/69 (52.2%) | 5.30 (3.21 to 8.75) | |
| TIA | ||||
| Analysis 1 | 60/1278 (4.7%) | 2/28 (7.1%) | 1.76 (0.40 to 7.80) | |
| Analysis 2 | 60/1413 (4.2%) | 2/32 (6.3%) | 1.55 (0.35 to 6.80) | |
| Analysis 3 | 195/1413 (13.8%) | 6/32 (18.8%) | 1.49 (0.60 to 3.69) | |
| Overall | ||||
| Analysis 1 | 257/4558 (5.6%) | 12/71 (16.9%) | 3.19 (1.69 to 6.01) | |
| Analysis 2 | 257/5069 (5.1%) | 12/101 (11.9%) | 2.36 (1.28 to 4.37) | |
| Analysis 3 | 768/5069 (15.2%) | 42/101 (41.6%) | 3.70 (2.45 to 5.60) | |
Analysis 1: using data with mRS change information available.
Analysis 2: sensitivity analysis, assuming the missing values of mRS change as 0 (≤0).
Analysis 3: sensitivity analysis, assuming the missing values of mRS change as 1 (≥1).
mRS change: mRS at visit 3−mRS at visit 2.
All estimates were adjusted by age, gender, BMI, aspirin usage before randomisation, PPI usage.
BMI, body mass index; mRS, modified Rankin Score; PPI, proton pump inhibitor; TIA, transient ischaemic attack.