Table 5.
Nested case-control analysis for thromboembolic events with onset after week 12: last known laboratory parameters
| Category | Cases N = 495 n (%) |
Controls N = 1473 n (%) |
Unadjusted OR (95% CI); P value |
Adjusted ORa (95% CI); P value |
Adjusted ORb (95% CI); P value |
|---|---|---|---|---|---|
| Hb rate of changec (g/dL/week) | |||||
| < − 0.5 | 20 (9.9) | 23 (3.5) | 3.73 (1.68–8.27); 0.001 | – | 0.95 (0.26–3.57); 0.945 |
| − 0.5 to < − 0.1 | 81 (39.9) | 199 (30.0) | 1.89 (1.19–3.01); 0.007 | – | 1.70 (0.83–3.49); 0.148 |
| − 0.1 to < 0.1 | 43 (21.2) | 208 (31.3) | Ref | – | Ref |
| 0.1 to < 0.5 | 46 (22.7) | 199 (30.0) | 1.11 (0.68–1.82); 0.686 | – | 0.99 (0.45–2.17); 0.975 |
| ≥ 0.5 | 13 (6.4) | 35 (5.3) | 1.75 (0.76–4.00); 0.188 | – | 1.46 (0.37–5.72); 0.588 |
| Last known Hb level (g/dL) | |||||
| < 10 | 111 (22.4) | 195 (13.2) | 2.12 (1.47–3.05); < 0.001 | 1.91 (1.04–3.50); 0.037 | – |
| 10 to < 12 | 321 (64.8) | 1042 (70.7) | 1.13 (0.83–1.54); 0.426 | 1.15 (0.71–1.85); 0.567 | – |
| ≥ 12 | 63 (12.7) | 236 (16.0) | Ref | Ref | – |
| Last known TSAT (%) | |||||
| < 10 | 34 (6.9) | 42 (2.9) | 3.13 (1.93–5.07); < 0.001 | 3.78 (1.71–8.39); 0.001 | 10.08 (2.56–39.60); 0.001 |
| 10 to < 30 | 294 (59.4) | 784 (53.4) | 1.45 (1.17–1.81); 0.001 | 1.51 (1.01–2.24); 0.042 | 2.45 (1.21–4.98); 0.013 |
| ≥ 30 | 167 (33.7) | 641 (43.7) | Ref | Ref | Ref |
| Last known ferritin level (ng/mL) | |||||
| < 50 | 64 (12.9) | 152 (10.3) | 1.30 (0.92–1.82); 0.14 | 0.96 (0.51–1.81); 0.908 | 0.60 (0.19–1.86); 0.375 |
| 50 to < 400 | 234 (47.3) | 720 (49.0) | 0.99 (0.79–1.25); 0.959 | 0.96 (0.67–1.39); 0.831 | 0.92 (0.49–1.72); 0.790 |
| ≥ 400 | 197 (39.8) | 598 (40.7) | Ref | Ref | Ref |
| Last known platelet count (104/µL) | |||||
| < 20 | 259 (52.3) | 802 (54.4) | Ref | Ref | Ref |
| 20 to < 30 | 185 (37.4) | 563 (38.2) | 1.01 (0.81–1.26); 0.920 | 1.03 (0.72–1.45); 0.889 | 1.49 (0.83–2.68); 0.187 |
| ≥ 30 | 51 (10.3) | 108 (7.3) | 1.47 (1.02–2.11); 0.038 | 1.09 (0.61–1.92); 0.778 | 1.46 (0.62–3.46); 0.389 |
| Last known hsCRP level (mg/dL) | |||||
| < 0.5 | 176 (43.0) | 585 (48.9) | Ref | Ref | Ref |
| 0.5 to < 1.5 | 126 (30.8) | 368 (30.7) | 1.12 (0.85–1.48); 0.407 | 1.02 (0.70–1.49); 0.901 | 1.04 (0.53–2.04); 0.909 |
| ≥ 1.5 | 107 (26.2) | 244 (20.4) | 1.42 (1.04–1.95); 0.026 | 1.23 (0.79–1.92); 0.357 | 0.69 (0.31–1.54); 0.360 |
| Last known MCV (fL) | |||||
| < 95 | 106 (37.3) | 304 (37.4) | 1.42 (0.81–2.49); 0.221 | 1.10 (0.61–1.99); 0.753 | 0.97 (0.37–2.56); 0.951 |
| 95 to < 105 | 147 (51.8) | 378 (46.6) | 1.74 (1.02–2.96); 0.042 | 1.45 (0.84–2.51); 0.185 | 1.74 (0.71–4.24); 0.223 |
| ≥ 105 | 31 (10.9) | 130 (16.0) | Ref | Ref | Ref |
| Last known roxadustat dose (mg/week) | |||||
| < 150 | 96 (19.4) | 356 (24.2) | Ref | Ref | Ref |
| 150 to < 600 | 309 (62.4) | 925 (62.8) | 1.24 (0.95–1.61); 0.106 | 1.01 (0.67–1.50); 0.980 | 1.23 (0.66–2.29); 0.524 |
| ≥ 600 | 90 (18.2) | 192 (13.0) | 1.82 (1.28–2.60); 0.001 | 1.17 (0.65–2.08); 0.603 | 0.60 (0.20–1.83); 0.369 |
If patients had missing data for parameters, they were removed from the analysis
CI confidence interval, Hb hemoglobin, hsCRP high-sensitivity C-reactive protein, MCV mean corpuscular volume, OR odds ratio, ref reference, TSAT transferrin saturation
aAdjusted ORs were calculated using a multivariate conditional logistic regression model with last known Hb level, ferritin level, TSAT, platelet count, hsCRP level, MCV, and roxadustat dose as categorical variables
bAdjusted ORs were calculated using a multivariate conditional logistic regression model with Hb rate of change and last known ferritin level, TSAT, platelet count, hsCRP level, MCV, and roxadustat dose as categorical variables
cHb rate of change was defined as a slope from a linear regression model estimated using Hb values in the preceding 4 weeks of event onset. Measurements prior to the baseline visit were removed from the calculation