Table 4.
SAAE | Unadjusted relative riska (95% CI) | P value | Adjusted relative riskb (95% CI) | P value |
---|---|---|---|---|
Any SAAEs (n = 496) | 2.0 (1.8–2.3) | <0.001 | 2.5 (2.1–2.8) | <0.001 |
Single-occurrence events | ||||
Hypertension (n = 384) | 3.1 (2.3–4.1) | <0.001 | 4.5 (3.5–5.9) | <0.001 |
Hyperglycemia (n = 482) | 1.0 (0.5–1.9) | 0.96 | 1.1 (0.5–2.3) | 0.76 |
Diabetes (n = 466) | 1.5 (1.0–2.0) | 0.03 | 1.9 (1.3–2.8) | <0.001 |
Overweight (n = 472) | 2.9 (2.2–3.9) | <0.001 | 3.2 (2.3–4.5) | <0.001 |
Obese (n = 464) | 2.3 (1.7–3.3) | <0.001 | 2.9 (2.0–4.2) | <0.001 |
Short stature (n = 173) | 2.2 (1.4–3.6) | <0.001 | 2.2 (1.4–3.6) | <0.001 |
Cataracts (n = 486) | 2.4 (0.7–8.0) | 0.1417 | 1.7 (0.4–6.6) | 0.43 |
Glaucoma (n = 495) | NA | NA | NA | NA |
Osteoporosis (n = 492) | 1.3 (0.5–3.6) | 0.66 | 1.4 (0.9–2.2) | 0.09 |
Osteonecrosis (n = 513) | 1.3 (0.4–4.3) | 0.72 | 1.1 (0.4–3.1) | 0.87 |
Psychosis (n = 494) | NA | NA | NA | NA |
Multiple-occurrence events | ||||
Fractures (n = 496) | 1.6 (0.6–4.2) | 0.38 | 0.9 (0.4–2.3) | 0.86 |
Any infection (n = 496) | 2.3 (1.5–3.8) | <0.001 | 2.3 (1.5–3.8) | <0.001 |
Pneumonia (n = 496) | 2.9 (1.8–4.8) | <0.001 | 2.9 (1.8–4.8) | <0.001 |
Septicemia/bacteremia (n = 496) | 0.6 (0.3–1.5) | 0.32 | 0.6 (0.3–1.5) | 0.32 |
Peritonitis (n = 496) | 3.3 (1.1–10.5) | 0.04 | 1.9 (0.6–6.2) | 0.27 |
Cellulitis (n = 496) | 1.8 (0.7–4.6) | 0.23 | 1.8 (0.7–4.6) | 0.23 |
NA, not available due to insufficient event rate; SAAE, steroid-associated adverse event.
Risk is reported per 1 mg/kg per day increase in dose (n = 496).
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.