Table 3.
SAAE | Unadjusted relative riska (95% CI) | P value | Adjusted relative riskb (95% CI) | P value |
---|---|---|---|---|
Any SAAEs (n = 884) | 1.3 (1.1–1.5) | <0.001 | 1.4 (1.3–1.6) | <0.001 |
Single-occurrence events | ||||
Hypertension (n = 668) | 1.2 (0.9–1.5) | 0.199 | 1.4 (1.1–1.8) | 0.01 |
Hyperglycemia (n = 816) | 1.1 (0.7–1.8) | 0.575 | 1.2 (0.9–2.1) | 0.19 |
Diabetes (n = 828) | 1.5 (1.2–1.9) | 0.002 | 1.8 (1.3–2.4) | <0.001 |
Overweight (n = 772) | 1.2 (0.9–1.6) | 0.286 | 1.2 (0.9–1.6) | 0.21 |
Obese (n = 815) | 1.1 (0.9–1.5) | 0.305 | 1.5 (1.2–1.9) | 0.002 |
Short stature (n = 374) | 1.1 (0.7–1.9) | 0.669 | 1.3 (0.7–2.4) | 0.33 |
Cataracts (n = 874) | 1.8 (0.7–4.7) | 0.252 | 1.3 (0.5–3.5) | 0.63 |
Glaucoma (n = 884) | 0.9 (0.2–4.3) | 0.868 | 1.1 (0.2–6.0) | 0.94 |
Osteoporosis (n = 880) | 1.7 (0.4–7.1) | 0.432 | 2.4 (0.6–10.2) | 0.23 |
Osteonecrosis (n = 884) | 1.8 (0.2–19.4) | 0.647 | 2.1 (0.2–23.7) | 0.54 |
Psychosis (n = 883) | — | — | — | — |
Multiple-occurrence events | ||||
Fractures (n = 884) | 3.3 (1.2–8.9) | 0.022 | 3.6 (1.3–9.9) | 0.015 |
Any infection (n = 884) | 2.0 (1.1–3.6) | 0.027 | 2.0 (1.1–3.5) | 0.015 |
Pneumonia (n = 884) | 2.3 (1.2–4.8) | 0.018 | 2.4 (1.2–4.8) | 0.012 |
Septicemia/bacteremia (n = 884) | 3.6 (1.1–12.0) | 0.035 | 3.7 (1.3–10.3) | 0.013 |
Peritonitis (n = 884) | 12.0 (1.5–94.2) | 0.019 | 6.4 (0.7–55.5) | 0.090 |
Cellulitis (n = 884) | 1.1 (0.5–2.4) | 0.762 | 1.2 (0.6–2.2) | 0.596 |
SAAE, steroid-associated adverse event.
Relative risk estimates are derived from a Poisson generalized estimating equation model that accounts for the repeated measures of subjects.
Adjusted for age; sex; race; ethnicity; duration of kidney disease; treatment with other immunosuppressive therapies including calcineurin inhibitor, cyclophosphamide, mycophenolate mofetil, and rituximab; estimated glomerular filtration rate; and urine protein:creatinine ratio.