Table 2 Predictors of any and very common frequency of HADR (only significant predictors are shown for the sake of clarity).
Frequency | Hematological Adverse Drug Reaction (HADR) | Factors that increase the risk factor (OR; 95% CI; p value) | Factors that decrease the risk factor (OR; 95% CI; p value) | Model features Hosmer and Lemeshow Test (chi-square; df; p value) Cox & Snell R2 Nagelkerke’s R2 | Figures |
|---|---|---|---|---|---|
ANY FREQUENCY | Any HADR | Generic (2.35; [1.65–3.34]; < 0.001) Biosimilar (5.91; [2.90–12.01]; < 0.001) EML (2.08; [1.59–2.74]; < 0.001) | – | 11.56; 8; 0.172 0.09 0.12 | Fig. 2A |
Anemia | Generic (1.76; [1.29–2.40]; < 0.001) Biosimilar (11.25; [5.41–23.38]; < 0.001) EML (2.32; [1.78–3.01]; < 0.001) | Route of administration (0.79; [0.65–0.96]; 0.016) | 12.58; 8; 0.127 0.11 0.15 | Fig. 2B | |
Leucopenia | Generic (2.10; [1.50–2.94]; < 0.001) EML (2.24; [1.72–2.92]; < 0.001) | – | 11.84; 8; 0.158 0.07 0.09 | Fig. 2C | |
Thrombocytopenia | Generic (2.37; [1.74–3.23]; < 0.001) Biosimilar (3.26; [1.89–5.64]; < 0.001) EML (2.53; [1.94–3.28]; < 0.001) | – | 8.41; 5; 0.135 0.10 0.14 | Fig. 2D | |
VERY COMMON | Any HADR | Biosimilar (3.32; [1.94–5.66]; < 0.001) Conditional approval (2.84; [1.41–5.72]; 0.004) EML (1.39; [1.01–1.92]; 0.042) | – | 12.39; 8; 0.135 0.05 0.08 | Fig. 3A |
Anemia | Biosimilar (2.27; [1.26–4.11]; 0.007) Conditional approval (3.41; [1.65–7.04]; < 0.001) EML (1.47; [1.02–2.11]; 0.038) | – | 10.35; 8; 0.241 0.04 0.07 | Fig. 3B | |
Leucopenia | Biosimilar (2.73; [1.56–4.79]; < 0.001) Conditional approval (2.24; [1.07–4.72]; 0.033) EML (1.59; [1.13–2.26]; 0.009) | – | 5.50; 8; 0.704 0.04 0.08 | Fig. 3C | |
Thrombocytopenia | Generic (1.67; [1.01–2.76]; 0.047) Biosimilar (3.85; [2.12–7.01]; < 0.001) Conditional approval (2.96; [1.36–6.44]; 0.006) Accelerated assessment (3.03; [1.35–6.81]; 0.007) Orphan medicines (1.93; [1.12–3.35]; 0.019) EML (1.57; [1.07–2.30]; 0.020) | – | 14.01; 8; 0.081 0.05 0.09 | Fig. 3D |
