TABLE 3.
Summary of the exposure–safety analysis (N = 429): base models.
| Analysis type | Factor analyzed | Number of patients with event, n (%) | p value | |||
|---|---|---|---|---|---|---|
| acMMAE | Unconjugated MMAE | |||||
| C6 AUC | C6 C max | C6 AUC | C6 C max | |||
| Logistic regression (AEs) | Grade ≥3 neutropenia | 179 (41.7) | 0.450 | 0.636 | 0.001 | 0.004 |
| Grade ≥3 febrile neutropenia | 58 (13.5) | 0.188 | 0.504 | <0.0005 | 0.001 | |
| Grade ≥2 neuropathy | 60 (14.0) | 0.042 | 0.003 | 0.525 | 0.827 | |
| Grade ≥3 infections or infestations | 65 (15.2) | 0.099 | 0.089 | <0.0005 | <0.0005 | |
| Grade ≥3 anemia | 52 (12.1) | 0.028 | 0.060 | <0.0005 | <0.0005 | |
| Grade ≥3 thrombocytopenia | 22 (5.1) | 0.011 | 0.020 | <0.0005 | <0.0005 | |
| Dose modification due to AE | 34 (7.9) | 0.199 | 0.394 | 0.866 | 0.757 | |
| CPH model | Time to first dose modification | 34 (7.9) | 0.164 | 0.341 | 0.797 | 0.689 |
| Linear regression (dose intensities) | Polatuzumab vedotin | – | 0.166 | 0.050 | <0.0005 | <0.0005 |
| Rituximab | – | 0.007 | 0.001 | <0.0005 | <0.0005 | |
| Doxorubicin | – | 0.035 | 0.006 | 0.001 | 0.001 | |
| Cyclophosphamide | – | 0.029 | 0.003 | <0.0005 | <0.0005 | |
| Prednisone | – | 0.563 | 0.623 | 0.390 | 0.341 | |
Abbreviations: ac, antibody‐conjugated; AE, adverse event; AUC, area under the concentration–time curve; C, cycle; C max, maximum concentration; CPH, Cox proportional hazards; MMAE, monomethyl auristatin E.