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 |