Table 2.
Summary of safety according to age subgroup.
| Age <65 years |
Age 65–74 years |
Age ≥75 years |
||||
|---|---|---|---|---|---|---|
| Rucaparib (n = 235)a |
Placebo (n = 117) |
Rucaparib (n = 113) |
Placebo (n = 64) |
Rucaparib (n = 24)a |
Placebo (n = 8) |
|
| Treatment duration, median (range), mo | 8.7 (0.1–43.4) | 5.5 (1.2–43.9) | 6.4 (0.2–38.1) | 5.2 (0.0–23.0) | 8.7 (2.9–32.8) | 5.4 (3.3–11.0) |
| Any-grade TEAE, n (%) | 235 (100.0) | 112 (95.7) | 113 (100.0) | 62 (96.9) | 24 (100.0) | 8 (100.0) |
| Grade ≥3 TEAE | 127 (54.0) | 19 (16.2) | 79 (69.9) | 10 (15.6) | 16 (66.7) | 1 (12.5) |
| Treatment interruption and/or dose reduction due to TEAE, n (%) | 154 (65.5) | 11 (9.4) | 93 (82.3) | 8 (12.5) | 20 (83.3) | 1 (12.5) |
| Treatment interruption due to TEAE | 141 (60.0) | 10 (8.5) | 83 (73.5) | 8 (12.5) | 19 (79.2) | 1 (12.5) |
| Dose reduction due to TEAE | 110 (46.8) | 3 (2.6) | 80 (70.8) | 4 (6.3) | 16 (66.7) | 1 (12.5) |
| Discontinued due to TEAE,b n (%) | 28 (11.9) | 2 (1.7) | 24 (21.2) | 1 (1.6) | 5 (20.8) | 0 |
| Deaths due to TEAE, n (%) | 5c (2.1) | 0 | 1d (0.9) | 2e (3.1) | 1f (4.2) | 0 |
| Deaths due to disease progression | 2 (0.9) | 0 | 0 | 1 (1.6) | 0 | 0 |
TEAE, treatment-emergent adverse event.
a
Three patients randomized to the rucaparib group (age <65 years, n = 2; age 75 years, n = 1) did not receive a dose of rucaparib and are excluded from the safety population.
b
Excluding disease progression.
c
Non–disease progression TEAEs leading to death: acute myeloid leukemia, n = 1; cardiac arrest, n = 1; myelodysplastic syndrome, n = 1.
d
Non–disease progression TEAE leading to death: hematophagic histiocytosis.
e
Non–disease progression TEAE leading to death: pulmonary embolism.
f
Non–disease progression TEAE leading to death: high grade B-cell lymphoma.