Table 3.
Adverse drug reactions by preferred term
| All patients | Unmatched patients | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All grades | Grade ≥ 3 | C20 | C25 | |||||||||
| All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |||||||||
| N | 660 | 190 | 159 | |||||||||
| Patients with any ADR | 511 (77.4) | 409 (62.0) | 149 (78.4) | 116 (61.1) | 142 (89.3)* | 129 (81.1) | ||||||
| Number of ADRs | 1113 | 644 | 317 | 177 | 323 | 211 | ||||||
| ADRs (Grade ≥ 3 in ≥2 patients), n (%) | ||||||||||||
| Pneumonia | 6 | (0.9) | 5 | (0.8) | 2 | (1.1) | 2 | (1.1) | 2 | (1.3) | 1 | (0.6) |
| Pyelonephritis | 3 | (0.5) | 3 | (0.5) | 0 | 0 | 1 | (0.6) | 1 | (0.6) | ||
| Sepsis | 4 | (0.6) | 4 | (0.6) | 2 | (1.1) | 2 | (1.1) | 1 | (0.6) | 1 | (0.6) |
| Septic shock | 3 | (0.5) | 3 | (0.5) | 0 | 0 | 1 | (0.6) | 1 | (0.6) | ||
| Anemiaa | 99 | (15.0) | 58 | (8.8) | 22 | (11.6) | 12 | (6.3) | 25 | (15.7) | 15 | (9.4) |
| Febrile neutropenia | 119 | (18.0) | 113 | (17.1) | 28 | (14.7) | 28 | (14.7) | 50 | (31.5) | 48 | (30.2) |
| Leukopeniab | 74 | (11.2) | 48 | (7.3) | 23 | (12.1) | 13 | (6.8) | 18 | (11.3) | 15 | (9.4) |
| Neutropeniac | 324 | (49.1) | 263 | (39.8) | 103 | (54.2) | 81 | (42.6) | 98 | (61.6) | 88 | (55.3) |
| Thrombocytopeniad | 77 | (11.7) | 36 | (5.5) | 29 | (15.3) | 11 | (5.8) | 16 | (10.1) | 7 | (4.4) |
| Bone marrow failure | 2 | (0.3) | 2 | (0.3) | 0 | 0 | 1 | (0.6) | 1 | (0.6) | ||
| Decreased appetite | 49 | (7.4) | 11 | (1.7) | 17 | (9.0) | 3 | (1.6) | 10 | (6.3) | 2 | (1.3) |
| Neuropathy peripheral | 10 | (1.5) | 2 | (0.3) | 4 | (2.1) | 2 | (1.1) | 2 | (1.3) | 0 | |
| Interstitial lung disease | 8 | (1.2) | 7 | (1.1) | 1 | (0.5) | 0 | 4 | (2.5) | 4 | (2.5) | |
| Pneumonitis | 2 | (0.3) | 2 | (0.3) | 0 | 0 | 0 | 0 | ||||
| Diarrhea | 66 | (10.0) | 21 | (3.2) | 21 | (11.1) | 5 | (2.6) | 16 | (10.1) | 6 | (3.8) |
| Nausea | 22 | (3.3) | 4 | (0.6) | 9 | (4.7) | 4 | (2.1) | 5 | (3.1) | 0 | |
| Vomiting | 11 | (1.7) | 3 | (0.5) | 1 | (0.5) | 0 | 3 | (1.9) | 2 | (1.3) | |
| Liver disorder | 3 | (0.5) | 3 | (0.5) | 0 | 0 | 1 | (0.6) | 1 | (0.6) | ||
| Malaise | 40 | (6.1) | 3 | (0.5) | 8 | (4.2) | 0 | 9 | (5.7) | 0 | ||
| Pyrexia | 22 | (3.3) | 4 | (0.6) | 7 | (3.7) | 1 | (0.5) | 4 | (2.5) | 1 | (0.6) |
*p < 0.01 vs C20 (Fisher’s test)
C20 20 mg/m2 cabazitaxel, C25 25 mg/m2 cabazitaxel, ADR Adverse drug reaction
aAnemia and hemoglobin decreased
bLeukopenia and white blood cell count decreased
cNeutropenia and neutrophil count decreased
dThrombocytopenia and platelet count decreased