Table 6.
Nested case-control analysis for thromboembolic events with onset after week 12
| Category | Cases N = 23 n (%) |
Controls N = 164 n (%) |
Unadjusted odds ratio (95% CI) |
P value | Adjusted odds ratio (95% CI)a |
P valuea |
|---|---|---|---|---|---|---|
| Average hemoglobin over the previous 8 weeks before the event onset (g/dL) | ||||||
| < 10.0 | 4 (17.4) | 9 (5.5) | 3.38 (0.76–14.97) | 0.108 | 1.68 (0.28–9.98) | 0.566 |
| 10.0 to < 11.0 | 10 (43.5) | 60 (36.6) | 1.57 (0.59–4.19) | 0.369 | 1.14 (0.39–3.38) | 0.811 |
| ≥ 11.0 | 9 (39.1) | 95 (57.9) | Ref | Ref | ||
| Geometric mean ferritin over the previous 8 weeks before the event onset (ng/mL) | ||||||
| < 30 | 9 (39.1) | 41 (25.0) | 2.77 (0.93–8.25) | 0.066 | 2.32 (0.77–6.98) | 0.136 |
| 30 to < 50 | 7 (30.4) | 33 (20.1) | 2.25 (0.72–7.06) | 0.163 | 1.73 (0.51–5.86) | 0.380 |
| ≥ 50 | 7 (30.4) | 90 (54.9) | Ref | Ref | ||
| Average TSAT over the previous 8 weeks before the event onset (%) | ||||||
| < 10 | 5 (21.7) | 10 (6.1) | 6.25 (1.52–25.62) | 0.011 | 4.29 (0.93–19.72) | 0.061 |
| 10 to < 20 | 7 (30.4) | 47 (28.7) | 1.67 (0.60–4.67) | 0.330 | 1.54 (0.55–4.37) | 0.414 |
| ≥ 20 | 11 (47.8) | 107 (65.2) | Ref | Ref | ||
| Average transferrin over the previous 8 weeks before the event onset (g/L) | ||||||
| < 2.0 | 4 (17.4) | 42 (25.6) | Ref | Ref | ||
| 2.0 to < 2.5 | 7 (30.4) | 83 (50.6) | 0.97 (0.26–3.66) | 0.962 | 0.73 (0.18–2.99) | 0.667 |
| ≥ 2.5 | 12 (52.2) | 39 (23.8) | 4.36 (1.23–15.39) | 0.022 | 3.16 (0.85–11.77) | 0.086 |
| Geometric mean hsCRP over the previous 16 weeks before the event onsetb (mg/dL) | ||||||
| < 0.1 | 8 (34.8) | 88 (53.7) | Ref | Ref | ||
| 0.1 to < 0.3 | 7 (30.4) | 47 (28.7) | 1.58 (0.52–4.80) | 0.417 | 1.55 (0.49–4.87) | 0.453 |
| ≥ 0.3 | 8 (34.8) | 29 (17.7) | 2.85 (0.98–8.35) | 0.056 | 2.86 (0.97–8.40) | 0.056 |
| Average MCV over the previous 8 weeks before the event onset (fL) | ||||||
| < 90 | 5 (21.7) | 21 (12.8) | 1.90 (0.60–6.04) | 0.275 | 1.69 (0.51–5.60) | 0.389 |
| 90 to < 95 | 6 (26.1) | 56 (34.1) | 1.83 (0.30–2.30) | 0.717 | 1.14 (0.38–3.37) | 0.819 |
| ≥ 95 | 12 (52.2) | 87 (53.0) | Ref | Ref | ||
| Average MCH over the previous 8 weeks before the event onset (pg) | ||||||
| < 29 | 6 (26.1) | 19 (11.6) | 3.53 (1.07–11.58) | 0.038 | 3.00 (0.88–10.27) | 0.080 |
| 29 to < 31 | 7 (30.4) | 52 (31.7) | 1.44 (0.50–4.11) | 0.498 | 1.60 (0.55–4.66) | 0.391 |
| ≥ 31 | 10 (43.5) | 93 (56.7) | Ref | Ref | ||
| Average MCHC over the previous 8 weeks before the event onset (g/L) | ||||||
| < 320 | 10 (43.5) | 40 (24.4) | 2.63 (0.85–8.11) | 0.092 | 2.15 (0.68–6.75) | 0.191 |
| 320 to < 330 | 7 (30.4) | 64 (39.0) | 1.11 (0.36–3.42) | 0.858 | 1.08 (0.35–3.39) | 0.893 |
| ≥ 330 | 6 (26.1) | 60 (36.6) | Ref | Ref | ||
| Average platelets over the previous 8 weeks before the event onset (104/µL) | ||||||
| < 15.0 | 6 (26.1) | 38 (23.2) | Ref | Ref | ||
| 15.0 to < 25.0 | 12 (52.2) | 95 (57.9) | 0.86 (0.29–2.54) | 0.783 | 0.77 (0.26–2.34) | 0.648 |
| ≥ 25.0 | 5 (21.7) | 31 (18.9) | 0.94 (0.23–3.86) | 0.933 | 0.82 (0.20–3.36) | 0.779 |
| Average roxadustat dose over the previous 8 weeks before event onset (mg) | ||||||
| < 50 | 6 (26.1) | 56 (34.1) | Ref | Ref | ||
| 50 to < 150 | 14 (60.9) | 103 (62.8) | 1.59 (0.54–4.66) | 0.394 | 1.35 (0.45–4.07) | 0.598 |
| ≥ 150 | 3 (13.0) | 5 (3.0) | 5.95 (1.07–33.16) | 0.042 | 3.77 (0.57–25.11) | 0.170 |
| Concomitant use of IV or oral iron therapy (including ferric citrate) | ||||||
| No | 8 (34.8) | 70 (42.7) | 0.96 (0.38–2.43) | 0.934 | 1.00 (0.38–2.61) | 0.995 |
| Yes | 15 (65.2) | 94 (57.3) | Ref | Ref | ||
Patients who experienced any event with onset before week 12 and did not experience any event with onset after week 12 were excluded from the analysis
CI confidence interval, hsCRP high-sensitivity C-reactive protein, IV intravenous, MCH mean corpuscular hemoglobin, MCHC mean corpuscular hemoglobin concentration, MCV mean corpuscular volume, Ref reference, TSAT transferrin saturation
aFor average roxadustat dose, we adjusted for average TSAT. For concomitant use of IV or oral iron therapy (including ferric citrate), we adjusted for ferritin and TSAT just prior to the event onset. For other factors, we adjusted for average roxadustat dose
bTo account for less frequent hsCRP assessments in each trial, the average hsCRP over the previous 16 weeks before event onset was included in this analysis