| Outcome | Unadjusted event rate per 1000 subjects (controlled portions of trials only) | Meta-analysis OR (95% CI) | Exposure-adjusted event rate per 1000 subject/years (controlled portions of trials only) | Meta-analysis RR (95% CI) | Exposure-adjusted event rate per 1000 subject/years (controlled and uncontrolled portions of trial) | Simple pooled RR (95% CI) | |||
| Placebo | Biological | Placebo | Biological | Placebo | Biological | ||||
| Death | 4.1 | 5.6 | 1.39 (0.74 to 2.62) | 5.2 | 6.0 | 1.23 (0.66 to 2.29) | 5.2 | 5.9 | 1.13 (0.57 to 2.27) |
| Serious adverse event | 118.0 | 139.3 | 1.11 (0.94 to 1.32) | 177.0 | 164.6 | 0.94 (0.77 to 1.15)H | 177.0 | 177.4 | 1.00 (0.87 to 1.16) |
| Serious infection | 27.5 | 32.5 | 1.21 (0.89 to 1.63) | 34.0 | 35.7 | 1.07 (0.81 to 1.43) | 34.0 | 36.7 | 1.08 (0.81 to 1.43) |
| Lymphoma | 0.4 | 1.0 | 1.26 (0.52 to 3.06) | 0.5 | 1.2 | 1.26 (0.53 to 3.01) | 0.5 | 1.2 | 2.41 (0.37 to 15.59) |
| Non-cutaneous cancers and melanoma | 3.7 | 5.4 | 1.31 (0.69 to 2.48) | 5.1 | 6.4 | 1.21 (0.63 to 2.32) | 5.1 | 7.1 | 1.40 (0.69 to 2.83) |
| Non-melanoma cutaneous cancer | 1.4 | 2.1 | 1.27 (0.67 to 2.42) | 1.8 | 1.9 | 1.01 (0.43 to 2.38) | 1.7 | 2.4 | 1.41 (0.41 to 4.91) |
H, Evidence of heterogeneity with fixed effects method, random effects analysis shown. OR, odds ratio; RA, rheumatoid arthritis; RR, risk ratio; TNF, tumour necrosis factor.