| Primary Analysis |
| Follow-up (yrs) | 15314 | 8829 | 13071 | 5910 | 1963 | 1685 |
| Infections (single failure) | 852 | 472 | 709 | 372 | 137 | 64 |
| Incidence per 100 patient years (95% CI) | 5.56 (5.20, 5.95) | 5.35 (4.89, 5.85) | 5.42 (5.04, 5.84) | 6.29 (5.69, 6.97) | 6.98 (5.90, 8.25) | 3.80 (2.97, 4.85) |
| Serious Infection Hazard Ratio (95% CI) | Ref | 0.94 (0.84, 1.06) | 0.97 (0.88, 1.07) |
1.15 (1.01, 1.30)
|
1.22 (1.02, 1.47)
|
0.65 (0.51, 0.84)
|
| Adjusted HR (95% CI) | Ref | 0.87 (0.77, 1.00) | 0.98 (0.88, 1.08) | 0.91 (0.80, 1.04) | 1.17 (0.93, 1.47) |
0.69 (0.52, 0.92)
|
| Adjusted Hazard Ratio By Infection Class (95% CI) |
| Sepsis/Bacteraemia | Ref | 0.83 (0.41, 1.66) | 1.04 (0.57, 1.91) |
2.08 (1.14, 3.80)
| 1.83 (0.63, 5.35) | 1.03 (0.24, 4.41) |
| Respiratory Infection | Ref | 1.16 (0.96, 1.39) |
1.23 (1.04, 1.45)
| 1.03 (0.83, 1.28) |
1.61 (1.15, 2.25)
| 0.96 (0.63, 1.46) |
| Skin Infection | Ref | 0.84 (0.66, 1.06) |
0.65 (0.52, 0.82)
|
0.54 (0.39, 0.75)
| 0.71 (0.40, 1.24) |
0.27 (0.11, 0.67)
|
| Gastrointestinal Infection | Ref | 0.95 (0.66, 1.38) | 0.77 (0.54, 1.11) | 0.93 (0.61, 1.42) | 1.45 (0.72, 2.90) | 0.51 (0.16, 1.63) |
| Bone/Joint Infection | Ref |
0.56 (0.38, 0.83)
| 0.80 (0.58, 1.09) | 0.67 (0.43, 1.02) | 0.46 (0.17, 1.27) | 0.73 (0.32, 1.68) |
| Genitourinary Infection | Ref | 0.74 (0.50, 1.07) | 1.18 (0.87, 1.59) | 1.15 (0.79, 1.68) | 0.67 (0.27, 1.66) | 0.55 (0.20, 1.52) |
| Other | Ref |
0.54 (0.31, 0.91)
| 1.08 (0.74, 1.58) | 0.72 (0.41, 1.29) | 1.15 (0.49, 2.67) | 0.50 (0.16, 1.60) |