TABLE A3.
Summary of Exposure-Adjusted AEs
| Event Count and Rate (events/100 person-months)a | Lenvatinib + Pembrolizumab (n = 238) | Standard of Care (n = 235) |
|---|---|---|
| Total exposure in person-monthsb | 1,633.65 | 1,017.23 |
| Total events (rate) | ||
| AEs | 3,329 (203.78) | 2,087 (205.17) |
| Drug-related AEs | 1,948 (119.24) | 1,133 (111.38) |
| Grade ≥3 AEs | 435 (26.63) | 321 (31.56) |
| Grade ≥3 drug-related AEs | 271 (16.59) | 182 (17.89) |
| Serious AEs | 175 (10.71) | 97 (9.54) |
| Serious drug-related AEs | 71 (4.35) | 25 (2.46) |
| AEs leading to death | 3 (0.18) | 3 (0.29) |
| Drug-related AEs leading to death | 2 (0.12) | 0 |
| AEs leading to drug discontinuation | 42 (2.57) | 11 (1.08) |
| Drug-related AEs leading to drug discontinuation | 35 (2.14) | 6 (0.59) |
| Serious AEs leading to drug discontinuation | 25 (1.53) | 6 (0.59) |
| Serious drug-related AEs leading to drug discontinuation | 20 (1.22) | 1 (0.10) |
Abbreviation: AEs, adverse events.
a
Event rate per 100 person-months of exposure = event count × 100/person-months of exposure.
b
Drug exposure defined as the between the first dose date + 1 day and the earlier of the last dose date + 30 or the database cutoff date.