Table 2.
Maximum grade adverse drug reactions by SOC and PT—adverse drug reactions with at least 5% of frequency for G3–G4 and all G5 reactions regardless of frequency.
| Carboplatin/PLD | Trabectedin/PLD | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| G0 | G1 | G2 | G3 | G4 | G5 | G3 + G4 + G5 | G0 | G1 | G2 | G3 | G4 | G5 | G3 + G4 + G5 | Chi-squared for trend | |
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | ||
| Haematological | |||||||||||||||
| Thrombocytopenia | 223 (75.9) | 21 (7.1) | 18 (6.1) | 18 (6.1) | 14 (4.8) | 0 (0.0) | 32 (10.9) | 263 (86.5) | 11 (3.6) | 6 (2.0) | 14 (4.6) | 9 (3.0) | 1 (0.3) | 24 (7.9) | 0.012 |
| Febrile neutropenia | 291 (99.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 2 (0.7) | 0 (0.0) | 2 (0.7) | 289 (95.1) | 0 (0.0) | 0 (0.0) | 9 (3.0) | 6 (2.0) | 0 (0.0) | 15 (4.9) | 0.005 |
| Leukopenia | 255 (86.7) | 7 (2.4) | 17 (5.8) | 14 (4.8) | 1 (0.3) | 0 (0.0) | 15 (5.1) | 259 (85.2) | 8 (2.6) | 14 (4.6) | 14 (4.6) | 8 (2.6) | 1 (0.3) | 23 (7.6) | 0.267 |
| Neutropenia | 182 (61.9) | 10 (3.4) | 35 (11.9) | 48 (16.3) | 19 (6.5) | 0 (0.0) | 67 (22.8) | 145 (47.7) | 14 (4.6) | 25 (8.2) | 64 (21.1) | 56 (18.4) | 0 (0.0) | 120 (39.5) | <0.001 |
| Non-haematological | |||||||||||||||
| Nausea | 199 (67.7) | 53 (18.0) | 35 (11.9) | 7 (2.4) | 0 (0.0) | 0 (0.0) | 7 (2.4) | 165 (54.3) | 59 (19.4) | 52 (17.1) | 27 (8.9) | 1 (0.3) | 0 (0.0) | 28 (9.2) | <0.001 |
| Vomiting | 242 (82.3) | 30 (10.2) | 17 (5.8) | 4 (1.4) | 1 (0.3) | 0 (0.0) | 5 (1.7) | 217 (71.4) | 43 (14.1) | 24 (7.9) | 20 (6.6) | 0 (0.0) | 0 (0.0) | 20 (6.6) | 0.001 |
| Hepatotoxicity | 278 (94.6) | 11 (3.7) | 3 (1.0) | 2 (0.7) | 0 (0.0) | 0 (0.0) | 2 (0.7) | 218 (71.7) | 9 (3.0) | 19 (6.3) | 48 (15.8) | 10 (3.3) | 0 (0.0) | 58 (19.1) | <0.001 |
| Sepsis | 292 (99.3) | 1 (0.3) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 1 (0.3) | 302 (99.3) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 1 (0.3) | 2 (0.7) | 0.696 |
| Stomatitis | 265 (90.1) | 18 (6.1) | 9 (3.1) | 2 (0.7) | 0 (0.0) | 0 (0.0) | 2 (0.7) | 262 (86.2) | 16 (5.3) | 18 (5.9) | 7 (2.3) | 1 (0.3) | 0 (0.0) | 8 (2.6) | 0.025 |
| Myelodysplastic syndrome | 293 (99.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 1 (0.3) | 304 (100) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | — |
| Pleural effusion | 293 (99.7) | 1 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 303 (99.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 1 (0.3) | — |
PLD pegylated liposomial doxorubicin, SOC System Organ Class (MedDRA), PT Preferred Term (MedDRA).