Table 3.
| First Report, October 2008 | Second Report, July 2011 | |||||||
|---|---|---|---|---|---|---|---|---|
| Trial Arm | Placebo (n = 8696) | Vitamin E (n = 8737) | Selenium (n = 8752) | Selenium + Vitamin E (n = 8703) | Placebo (n = 8696) | Vitamin E (n = 8737) | Selenium (n = 8752) | Selenium + Vitamin E (n = 8702) |
| Any cancer, including prostate a | ||||||||
| No. events | 824 | 856 | 837 | 846 | 1108 | 1190 | 1132 | 1149 |
| HR (99% CI) | 1 (reference) | 1.03 (0.91–1.17) | 1.01 (0.89–1.15) | 1.02 (0.90–1.16) | 1 (reference) | 1.07 (0.96–1.19) | 1.02 (0.92–1.14) | 1.02 (0.92–1.12) |
| Lung cancer | ||||||||
| No. events | 67 | 67 | 75 | 78 | 92 | 104 | 94 | 104 |
| HR (99% CI) | 1 (reference) | 1.00 (0.64–1.55) | 1.12 (0.73–1.72) | 1.16 (0.76–1.78) | 1 (reference) | 1.11 (0.76–1.61) | 1.02 (0.70–1.50) | 1.11 (0.76–1.62) |
| Colorectal cancer | ||||||||
| No. events | 60 | 66 | 63 | 77 | 75 | 85 | 74 | 93 |
| HR (99% CI) | 1 (reference) | 1.09 (0.69–1.73) | 1.05 (0.66–1.67) | 1.28 (0.82–2.00) | 1 (reference) | 1.09 (0.72–1.64) | 0.96 (0.63–1.46) | 1.21 (0.81–1.81) |
| Other primary cancer | ||||||||
| No. events | 306 | 274 | 292 | 290 | 579 | 570 | 557 | 594 |
| HR (99% CI) | 1 (reference) | 0.89 (0.72–1.10) | 0.95 (0.77–1.17) | 0.94 (0.76–1.16) | 1 (reference) | 0.97 (0.83–1.14) | 0.96 (0.83–1.13) | 1.02 (0.92–1.14) |
| Diabetes | ||||||||
| No. events | 669 | 700 | 724 | 660 | 869 | 918 | 913 | 875 |
| HR (99% CI) | 1 (reference) | 1.04 (0.91–1.18) | 1.07 (0.94–1.22) | 0.97 (0.85–1.11) | 1 (reference) | 1.05 (0.93–1.17) | 1.04 (0.93–1.17) | 0.99 (0.89–1.12) |
| Any cardiovascular event | ||||||||
| No. events | 1050 | 1034 | 1080 | 1041 | n.r. b | n.r. | n.r. | n.r. |
| HR (99% CI) | 1 (reference) | 0.98 (0.88–1.09) | 1.02 (0.92–1.13) | 0.99 (0.89–1.10) | ||||
| Cardiovascular events, grade ≥4 | ||||||||
| No. events | n.r. | n.r. | n.r. | n.r. | 969 | 909 | 939 | 943 |
| HR (99% CI) | 1 (reference) | 0.93 (0.83–1.05) | 0.97 (0.86–1.09) | 0.97 (0.86–1.09) | ||||
| Deaths, all cause | ||||||||
| No. events | 382 | 358 | 378 | 359 | 564 | 571 | 551 | 542 |
| HR (99% CI) | 1 (reference) | 0.93 (0.77–1.13) | 0.99 (0.82–1.19) | 0.94 (0.77–1.13) | 1 (reference) | 1.01 (0.86–1.17) | 0.98 (0.84–1.14) | 0.96 (0.82–1.12) |
| Bioadherence Trial arm | Placebo (n = 285) | Vitamin E (n = 290) | Selenium (n = 277) | Selenium + Vitamin E (n = 257) | ||||
| Serum selenium, μg/L | ||||||||
| Baseline, mean | 137.6 | 135.9 | 135.0 | 136.4 | n.r. | n.r. | n.r. | n.r. |
| IQR | 124.7–151.8 | 122.4–148.4 | 123.4–145.9 | 122.9–150.0 | ||||
| 6-months visit, mean | 137.4 | 138.4 | 223.4 | 227.0 | ||||
| IQR | 123.3–152.0 | 124.1–154.0 | 198.6–251.8 | 199.4–251.2 | ||||
| 1st annual visit, mean | 138.1 | 137.7 | 232.4 | 228.5 | ||||
| IQR | 125.2–152.2 | 120.1–139.9 | 204.2–261.4 | 205.5–258.1 | ||||
| 2nd annual visit, mean | 132.0 | 129.8 | 228.0 | 220.7 | ||||
| IQR | 120.8–143.1 | 126.2–158.6 | 206.3–256.9 | 194.0–249.5 | ||||
| 4th annual visit, mean | 140.1 | 143.8 | 251.6 | 253.1 | ||||
| IQR | 124.3–150.8 | 126.2–158.6 | 218.7–275.0 | 210.5–283.0 | ||||
a Numbers for specific types of cancers (lung, colorectal, other primary cancers, prostate cancers from Table 2) may not sum to number of individuals with cancer (described as “any cancer”) due to multiple cancers per person. b n.r.: not reported.