Table 2 a Patients with any predefined adverse event of any grade by allocated treatment arm and drug (intention-to-treat population) and comparison between the two arms. b Patients with any predefined adverse event grade 3 or 4 by allocated treatment arm and drug (intention-to-treat population) and comparison between the two arms
a | |||||
|---|---|---|---|---|---|
Arm A | Arm B | P value | |||
Paclitaxel | Palbociclib | Paclitaxel | Palbociclib | ||
N = 89 | N = 89 | N = 90 | N = 90 | ||
Allergic Reaction | 3 (3.3%) | 0 | 0 | 1 (1.1%) | 0.249 |
Alopecia | 1 (1.1%) | 0 | 0 | 2 (2.2%) | 0.626 |
Anemia | 0 | 0 | 1 (1.1%) | 0 | 0.846 |
Constipation | 0 | 0 | 0 | 0 | 1.000 |
Diarrhea | 2 (2.2%) | 0 | 0 | 3 (3.3%) | 0.496 |
Elevated liver transaminases | 0 | 2 (2.2%) | 2 (2.2%) | 0 | 0.308 |
Fatigue | 10 (11.2%) | 0 | 0 | 6 (6.6%) | 0.456 |
Headache | 1 (1.1%) | 1 (1.1%) | 1 (1.1%) | 0 | 0.405 |
Oral mucositis | 3 (3.3%) | 2 (2.2%) | 1 (1.1%) | 4 (4.4%) | 0.180 |
Myalgia | 0 | 0 | 0 | 1 (1.1%) | 1.000 |
Nausea | 0 | 2 (2.2%) | 5 (5.5%) | 3 (3.3%) | 0.846 |
Neutropenia | 2 (2.2%) | 44 (49.4%) | 51 (56.6%) | 1 (1.1%) | 0.873 |
Peripheral sensory neuropathy | 44 (49.4%) | 1 (1.1%) | 0 | 47 (52.2%) | 0.433 |
Rash | 14 (15.7%) | 3 (3.3%) | 1 (1.1%) | 9 (9.9%) | 0.236 |
Leukopenia | 5 (5.6%) | 7 (7.8%) | 8 (8.8%) | 2 (2.2%) | 1.000 |
b | |||||
|---|---|---|---|---|---|
Arm A | Arm B | P value | |||
Paclitaxel | Palbociclib | Paclitaxel | Palbociclib | ||
N = 89 | N = 89 | N = 90 | N = 90 | ||
Allergic Reaction | 1 (1.1%) | 0 | 0 | 1 (1.1%) | 1.000 |
Anemia | 1 (1.1%) | 0 | 0 | 0 | 0.497 |
Diarrhea | 1 (1.1%) | 0 | 3 | 0 | 1.000 |
Elevated liver transaminases | 0 | 0 | 0 | 1 (1.1%) | 0.121 |
Fatigue | 1 (1.1%) | 0 | 0 | 1 (1.1%) | 1.000 |
Headache | 1 (1.1%) | 0 | 0 | 0 | 0.497 |
Nausea | 0 | 0 | 0 | 1 (1.1%) | 1.000 |
Neutropenia | 5 (5.6%) | 32 (35.9%) | 35 (38.8%) | 3 (3.3%) | 1.000 |
Peripheral sensory neuropathy | 4 (4.5%) | 0 | 0 | 4 (4.4%) | 1.000 |
Rash | 1 (1.1%) | 0 | 0 | 0 | 0.497 |
Leukopenia | 1 (1.1%) | 1 (1.1%) | 1 (1.1%) | 0 | 0.621 |
