Table 3.
Maximum toxicities
| Toxicity | G1 or G2 n (%) |
G3 n (%) |
G4 n (%) |
G3 + G4 n (%) |
|---|---|---|---|---|
| Trabectedin safety population (N = 123) | ||||
| Allergic reaction | 2 (1.6) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Haemoglobin | 37 (30.1) | 5 (4.1) | 1 (0.8) | 6 (4.9) |
| Leucocytes/WBC | 33 (26.8) | 12 (9.8) | 3 (2.4) | 15 (12.2) |
| Neutrophils | 25 (20.3) | 17 (13.8) | 10 (8.1) | 27 (22.0) |
| Platelets | 6 (4.9) | 3 (2.4) | 2 (1.6) | 5 (4.1) |
| Atrial fibrillation | 1 (0.8) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Fatigue | 32 (26.0) | 4 (3.3) | 0 (0.0) | 4 (3.3) |
| Infusion site extravasation | 0 (0.0) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Hyperglycaemia | 1 (0.8) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Anorexia | 14 (11.4) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Constipation | 30 (24.4) | 2 (1.6) | 0 (0.0) | 2 (1.6) |
| Diarrhoea | 5 (4.1) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Nausea/vomiting | 46 (37.4) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Obstruction, colon | 0 (0.0) | 0 (0.0) | 1 (0.8) | 1 (0.8) |
| Perforation, bowel | 0 (0.0) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Alkaline ph. increased | 4 (3.3) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| ALT increased | 19 (15.4) | 7 (5.7) | 0 (0.0) | 7 (5.7) |
| AST increased | 17 (13.8) | 6 (4.9) | 1 (0.8) | 7 (5.7) |
| Cholecystitis | 0 (0.0) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| GGT increase | 8 (6.5) | 4 (3.3) | 0 (0.0) | 4 (3.3) |
| Hepatotoxicity | 7 (5.7) | 4 (3.3) | 0 (0.0) | 4 (3.3) |
| Infection/fever | 13 (10.6) | 2 (1.6) | 0 (0.0) | 2 (1.6) |
| C.P.K. increase | 5 (4.1) | 2 (1.6) | 0 (0.0) | 2 (1.6) |
| Hyponatraemia | 0 (0.0) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Pain | 18 (14.6) | 1 (0.8) | 1 (0.8) | 2 (1.6) |
| Dyspnoea | 7 (5.7) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Pulmonary embolism | 0 (0.0) | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Creatinine | 6 (4.9) | 0 (0.0) | 1 (0.8) | 1 (0.8) |
| Thrombosis, vein | 0 (0.0) | 1 (0.8) | 1 (0.8) | 2 (1.6) |
| Gemcitabine + docetaxel safety population (N = 39) | ||||
| Haemoglobin | 25 (64.1) | 6 (15.4) | 0 (0.0) | 6 (15.4) |
| Leucocytes/WBC | 10 (25.6) | 8 (20.5) | 2 (5.1) | 10 (25.6) |
| Neutrophils | 7 (17.9) | 9 (23.1) | 5 (12.8) | 14 (35.9) |
| Platelets | 13 (33.3) | 6 (15.4) | 1 (2.6) | 7 (17.9) |
| Fatigue | 11 (28.2) | 1 (2.6) | 0 (0.0) | 1 (2.6) |
| Dermatitis | 1 (2.6) | 1 (2.6) | 0 (0.0) | 1 (2.6) |
| Enteritis | 0 (0.0) | 0 (0.0) | 1 (2.6) | 1 (2.6) |
| Perforation, rectum | 0 (0.0) | 0 (0.0) | 1 (2.6) | 1 (2.6) |
| Infection/fever | 9 (23.1) | 1 (2.6) | 1 (2.6) | 2 (5.1) |
| Oedema, limb | 0 (0.0) | 1 (2.6) | 0 (0.0) | 1 (2.6) |
| Neuropathy, sensory | 3 (7.7) | 1 (2.6) | 0 (0.0) | 1 (2.6) |
| Pain, abdomen | 2 (5.1) | 1 (2.6) | 0 (0.0) | 1 (2.6) |
| Fistula, genitourinary | 0 (0.0) | 1 (2.6) | 0 (0.0) | 1 (2.6) |
| Hydronephrosis | 0 (0.0) | 1 (2.6) | 0 (0.0) | 1 (2.6) |