Table 2.
Observed versus expected vascular thrombotic events after vaccination with the Ad26.COV2.S vaccine in the Sisonke study, by sex and age
| Observed count | Person years | Observed incidence rate per 100 000 person years (95% CI) | Expected incidence rate per 100 000 person years (95% CI) | Expected count | Observed to expected ratio (95% CI) | |
| Venous thromboembolism | ||||||
| Total No of pulmonary embolism events | 11 | 94 743.07 | 11.61 (6.43 to 20.97) | 74.0 (72.3 to 75.7) | 70.11 | 0.16 (0.08 to 0.28) |
| Men: | ||||||
| Aged 60-69 years | 1 | 1677.95 | 59.60 (8.39 to 423.08) | 151.3 (141.1 to 162.1) | 2.54 | 0.39 (0.01 to 2.19) |
| Women: | ||||||
| Aged 30-39 years | 3 | 20 135.48 | 14.90 (4.81 to 46.20) | 40.1 (35.4 to 45.2) | 8.07 | 0.37 (0.08 to 1.09) |
| Aged 40-49 years | 4 | 21 204.73 | 18.86 (7.08 to 50.26) | 50.1 (44.9 to 55.8) | 10.62 | 0.38 (0.10 to 0.96) |
| Aged 60-69 years | 3 | 4137.99 | 72.50 (23.38 to 224.79) | 134.9 (125.4 to 145.0) | 5.58 | 0.54 (0.11 to 1.57) |
| Total No of deep vein thrombosis events | 4 | 94 743.07 | 4.22 (1.58 to 11.25) | 93.9 (92.0 to 95.9) | 88.96 | 0.04 (0.01 to 0.12) |
| Women: | ||||||
| Aged 20-29 years | 1 | 9989.95 | 10.01 (1.41 to 71.06) | 58.5 (52.4 to 65.2) | 5.84 | 0.17 (0 to 0.95) |
| Aged 30-39 years | 2 | 20 135.48 | 9.93 (2.48 to 39.72) | 71.8 (65.5 to 78.6) | 14.46 | 0.14 (0.02 to 0.5) |
| Aged 40-49 years | 1 | 21 204.73 | 4.72 (0.66 to 33.48) | 80.4 (73.7 to 87.5) | 17.05 | 0.06 (0 to 0.33) |
| Total No of cerebral venous sinus thrombosis events | 1 | 94 743.07 | 1.06 (0.15 to 7.49) | 1.2 (1.0 to 1.5) | 1.14 | 0.88 (0.02 to 4.9) |
| Women: | ||||||
| Aged 30-39 years | 1 | 20 135.48 | 4.97 (0.70 to 35.26) | 1.8 (0.9 to 3.2) | 0.36 | 2.76 (0.07 to 15.37) |
| Arterial thrombosis | ||||||
| Total No of ischaemic stroke events | 5 | 94 743.07 | 5.28 (2.20 to 12.68) | 29.6 (28.5 to 30.7) | 28.04 | 0.18 (0.06 to 0.42) |
| Women: | ||||||
| Aged 30-39 years | 2 | 20 135.48 | 9.93 (2.48 to 39.72) | 4.0 (2.6 to 5.8) | 0.81 | 2.48 (0.30 to 8.97) |
| Aged 40-49 years | 2 | 21 204.73 | 9.43 (2.36 to 37.71) | 8.2 (6.2 to 10.7) | 1.74 | 1.15 (0.14 to 4.16) |
| Aged 50-59 years | 1 | 15 054.54 | 6.64 (0.94 to 47.16) | 17.3 (14.4 to 20.7) | 2.6 | 0.38 (0.01 to 2.14) |
| Total No of acute coronary syndrome events | 2 | 94 743.07 | 2.11 (0.53 to 8.44) | 138.8 (136.5 to 141.2) | 131.5 | 0.02 (0 to 0.05) |
| Men: | ||||||
| Aged 60-69 years | 1 | 1677.95 | 59.60 (8.39 to 423.08) | 437.2 (419.7 to 455.4) | 7.34 | 0.14 (0 to 0.76) |
| Women: | ||||||
| Aged 40-49 years | 1 | 21 204.73 | 4.72 (0.66 to 33.48) | 33.9 (29.7 to 38.7) | 7.19 | 0.14 (0 to 0.78) |
| Vaccine induced immune thrombocytopenia and thrombosis | ||||||
| Total No of pulmonary embolism and thrombocytopenia events | 1 | 94 743.07 | 1.06 (0.15 to 7.49) | 0.9 (0.7 to 1.1) | 0.85 | 1.17 (0.03 to 6.53) |
| Women: | ||||||
| Aged 40-49 years | 1 | 21 204.73 | 4.72 (0.66 to 33.48) | 0.3 (0.1 to 0.8) | 0.06 | 15.72 (0.4 to 87.58) |
| Total No of cerebral sinus venous thrombosis and thrombocytopenia events | 1 | 94 743.07 | 1.06 (0.15 to 7.49) | 0.1 (0.1 to 0.2) | 0.09 | 10.55 (0.27 to 58.81) |
| Women: | ||||||
| Aged 20-29 years | 1 | 9989.98 | 10.01 (1.41 to 71.06) | – | – | – |
CI=confidence interval.