Table 1.
increase of SAE rate in 18–64 year subjects vs > 64 year subjects |
increase of SAE rate in ChA vs BNT in 18–64 year subjects |
increase of SAE rate in ChA vs BNT in >64 year subjects |
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BNT mean (95% CI) p value | ChAdOx1 nCoV-19 mean (95% CI) p value | AE rate of ChA over the AE rate of BNT mean (95%CI) | fold risk mean (95% CI) p value | AE rate of ChA over the AE rate of BNT mean (95%CI) |
fold risk mean (95% CI) p value |
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Severe AEs more frequent in younger (>2.0) | cerebral venous thrombosis | 2.0 (1.7–2.3) p < 0.01a | 5.7 (5.1–6.2) p < 0.0001 | 12.7 (12.3–13.2) | 12.4 (11.2–13.6) p < 0.01a | 1.9 (1.8–2.0) | 4.4 (4.0–4.7) p < 0.0001 |
splanchnic vein thrombosis | 2.1 (1.8–2.4) p < 0.0001 | 4.0 (3.7–4.3) p < 0.0001 | 3.6 (3.5–3.7) | 12.4 (11.2–13.5) p < 0.0001 | 0.8 (0.8–0.9) | 6.5 (6.0–6.9) p < 0.0001 | |
thrombocytopenia | 1.9 (1.6–2.2) p < 0.01a | 2.5 (2.3–2.7) p < 0.0001 | 23.6 (22.6–24.6) | 6.6 (6.0–7.2) p < 0.01a | 9.0 (8.5–9.6) | 5.0 (4.6–5.4) p < 0.0001 | |
other bleeding events | 2.7 (2.3–3.1) p < 0.01a | 2.4 (2.3–2.6) p < 0.0001 | 11.6 (10.7–12.7) | 2.5 (2.3–2.8) p < 0.01a | 5.1 (4.7–5.5) | 2.8 (2.6–3.0) p < 0.0001 | |
Severe AEs with similar rate in younger and older (2.0–0.6) | gastrointestinal bleeding | 1.6 (1.3–1.8) p < 0.001 | 1.6 (1.5–1.8) p < 0.0001 | 4.4 (4.0–4.8) | 2.4 (2.1–2.6) p < 0.0001 | 2.6 (2.3–2.8) | 2.2 (2.1–2.4) p < 0.0001 |
cerebral bleeding | 0.6 (0.6–0.7) p < 0.01a | 1.4 (1.3–1.5) p < 0.0001 | 9.2 (8.8–9.6) | 5.9 (5.4–6.5) p < 0.01a | 4.9 (4.5–5.3) | 2.7 (2.5–2.9) p < 0.01a | |
other venous thrombosis | 1.2 (1.0–1.4) p < 0.01a | 1.2 (1.1–1.3) p < 0.0001 | 43.9 (41.9–45.9) | 5.9 (5.4–6.4) p < 0.01a | 38.0 (35.8–40.3) | 6.1 (5.7–6.5) p < 0.0001 | |
disseminated intravascular coagulation | 0.9 (0.8–1.1) p > 0.05a | 1.0 (0.9–1.1) p > 0.05 | 1.4 (1.4–1.5) | 18.8 (17.0–20.6) p < 0.01a | 1.4 (1.3–1.5) | 17.0 (15.8–18.1) p < 0.01a | |
pulmonary thromboembolism | 0.8 (0.6–0.9) p < 0.01a | 0.9 (0.8–1.0) p < 0.01 | 24.0 (22.8–25.2) | 4.7 (4.3–5.1) p < 0.01a | 25.1 (23.5–26.8) | 4.0 (3.7–4.2) p < 0.0001 | |
Severe AEs more frequent in older (<0.6) | ischemic stroke | 0.6 (0.5–0.6) p < 0.01a | 0.6 (0.5–0.6) p < 0.0001 | 11.0 (10.3–11.7) | 3.4 (3.1–3.7) p < 0.01a | 19.1 (17.8–20.5) | 3.3 (3.1–3.6) p < 0.0001 |
KS normality test failed.