Table 2.
Extent of exposure and adverse events before and after weighting
| Before weighting | After weighting | |||||
|---|---|---|---|---|---|---|
| Second-line therapy (n = 41) | Later-line therapy (n = 71) | All (n = 112) | Second-line therapy (ESS = 27) | Later-line therapy (ESS = 59) | All (ESS = 86) | |
| Extent of exposure | ||||||
| Median duration of treatment (months) | 20.53 | 20.27 | 20.4 | 22.0 | 18.8 | 19.9 |
| Dose reduction due to AE, % | 2.4 | 2.8 | 2.7 | 1.8 | 2.4 | 2.2 |
| Dose interruption due to AE, % | 4.9 | 14.1 | 10.7 | 3.7 | 11.2 | 8.5 |
| Dose modification due to AE, % | 7.3 | 14.1 | 11.6 | 5.5 | 11.2 | 9.2 |
| Treatment discontinuation, % | 51.2 | 56.3 | 54.5 | 46.9 | 58.3 | 54.3 |
| Due to AE, % | 17.1 | 9.9 | 12.5 | 10.6 | 11.0 | 10.9 |
| Due to PD, % | 34.1 | 43.7 | 40.2 | 36.4 | 42.9 | 40.6 |
| Due to withdrawal, % | 0.0 | 1.4 | 0.9 | 0.0 | 3.3 | 2.1 |
| Due to investigators, % | 0.0 | 1.4 | 0.9 | 0.0 | 1.1 | 0.7 |
| Adverse events | ||||||
| At least one AE, % | 95.1 | 97.2 | 96.4 | 95.4 | 98.2 | 97.2 |
| At least one grade ≥ 3 AE, % | 51.2 | 50.7 | 50.9 | 47.3 | 48.1 | 47.8 |
| At least one AE leading to death, % | 4.9 | 8.5 | 7.1 | 3.1 | 7.9 | 6.2 |
| At least one SAE, % | 41.5 | 29.6 | 33.9 | 38.3 | 28.1 | 31.7 |
| At least one AESI, % | 78.1 | 91.6 | 86.6 | 82.5 | 91.3 | 88.2 |
| Hypertension a, % | 12.2 | 11.3 | 11.6 | 12.2 | 12.7 | 12.5 |
| Major hemorrhage b, % | 2.4 | 7.0 | 5.4 | 1.0 | 6.1 | 4.3 |
| Atrial fibrillation/flutter | 2.4 | 1.4 | 1.8 | 1.0 | 2.5 | 2.0 |
| Grade ≥ 3 atrial fibrillation/flutter | 0 | 1.4 | 0.9 | 0 | 2.5 | 1.6 |
AE adverse events, AESI adverse events of special interest, PD progressive diseases, SAE serious AE, ESS effective sample size
aIncludes preferred terms hypertension and blood pressure increased
bIncludes preferred term renal haematoma