Table 3 Safety analysis of subgroups (as treated population)
Age group | <65 years (n = 86) | ≥65 years (n = 74) | ||||
P+ L (n = 46) | L (n = 40) | P + L (n = 37) | L (n = 37) | |||
AEs (all causality), n (%) | 46 (100.0 %) | 33 (82.5 %) | 37 (100.0 %) | 32 (86.5 %) | ||
Grade 3–4 AEs (all causality), n (%) | 37 (80.4 %) | 4 (10.0 %) | 27 (73.0 %) | 12 (32.4 %) | ||
5 most common AEs that had a higher (>10 %) incidence in the P + L arm than in the L arm | Neutropenia, leukopenia, fatigue, anemia, alopecia | Neutropenia, leukopenia, fatigue, anemia, nausea | ||||
SAEs (all causality), n (%) | 7 (15.2 %) | 1 (2.5 %) | 11 (29.7 %) | 4 (10.8 %) | ||
Permanent discontinuation due to AEs (all causality), n (%) | 6 (13.0 %) | 1 (2.5 %) | 6 (16.2 %) | 1 (2.7 %) | ||
Dose reductions due to AEs (all causality), n (%) | 18 (39.1 %) | NA | 14 (37.8 %) | NA | ||
Histological type | Ductal carcinoma (n = 113) | Lobular carcinoma (n = 36) | ||||
P+ L (n = 62) | L (n = 51) | P + L (n = 18) | L (n = 18) | |||
AEs (all causality), n (%) | 62 (100.0 %) | 44 (86.3 %) | 18 (100.0 %) | 13 (72.2 %) | ||
Grade 3–4 AEs (all causality), n (%) | 47 (75.8 %) | 13 (25.5 %) | 14 (77.8 %) | 2 (11.1 %) | ||
5 most common AEs that had a higher (>10 %) incidence in the P + L arm than in the L arm | Neutropenia, fatigue, leukopenia, anemia, nausea | Neutropenia, anemia, leukopenia, asthenia, alopecia | ||||
SAEs (all causality), n (%) | 12 (19.4 %) | 5 (9.8 %) | 4 (22.2 %) | 0 | ||
Permanent discontinuation due to AEs (all causality), n (%) | 8 (12.9 %) | 1 (2.0 %) | 4 (22.2 %) | 1 (5.6 %) | ||
Dose reductions due to AEs (all causality), n (%) | 27 (43.5 %) | NA | 5 (27.8 %) | NA | ||
Prior systemic treatment | None (n = 80) | Yes (n = 80) | ||||
P+ L (n = 43) | L (n = 37) | P + L (n = 40) | L (n = 40) | |||
AEs (all causality), n (%) | 43 (100.0 %) | 32 (86.5 %) | 40 (100.0 %) | 33 (82.5 %) | ||
Grade 3–4 AEs (all causality), n (%) | 30 (69.8 %) | 5 (13.5 %) | 34 (85.0 %) | 11 (27.5 %) | ||
5 most common AEs that had a higher (>10 %) incidence in the P + L arm than in the L arm | Neutropenia, fatigue, leukopenia, anemia, alopecia | Neutropenia, leukopenia, anemia, nausea, thrombocytopenia | ||||
SAEs (all causality), n (%) | 7 (16.3 %) | 2 (5.4 %) | 11 (27.5 %) | 3 (7.5 %) | ||
Permanent discontinuation due to AEs (all causality), n (%) | 7 (16.3 %) | 1 (2.7 %) | 5 (12.5 %) | 1 (2.5 %) | ||
Dose reductions due to AEs (all causality), n (%) | 17 (39.5 %) | NA | 15 (37.5 %) | NA | ||
Disease sitea | Bone-only (n = 28) | Visceral (n = 80) | Other (n = 52) | |||
P + L (n = 17) | L (n = 11) | P + L (n = 37) | L (n = 43) | P + L (n = 29) | L (n = 23) | |
AEs (all causality), n (%) | 17 (100.0 %) | 10 (90.9 %) | 37 100.0 %) | 36 (83.7 %) | 29 (100.0 %) | 19 (82.6 %) |
Grade 3–4 AEs (all causality), n (%) | 15 (88.2 %) | 2 (18.2 %) | 27 (73.0 %) | 12 (27.9 %) | 22 (75.8 %) | 2 (8.7 %) |
5 most common AEs that had a higher (>10 %) incidence in the P + L arm than in the L arm | Neutropenia, fatigue, leukopenia, nausea, anemia | Neutropenia, leukopenia, fatigue, anemia, decreased appetite | Neutropenia, leukopenia, anemia fatigue, hot flush | |||
SAEs (all causality), n (%) | 4 (23.5 %) | 1 (9.1 %) | 10 (27.0 %) | 3 (7.0 %) | 4 (13.8 %) | 1 (4.3 %) |
Permanent discontinuation due to AEs (all causality), n (%) | 2 (11.8 %) | 0 | 7 (18.9 %) | 1 (2.3 %) | 3 (10.3 %) | 1 (4.3 %) |
Dose reductions due to AEs (all causality), n (%) | 5 (29.4 %) | NA | 14 (37.8 %) | NA | 13 (44.8 %) | NA |