Table 3. Most frequent grade III/IV adverse effects (NCI-CTC) observed in BDC and GBC trials.
|
BDC
|
GBC
|
|||||||
|---|---|---|---|---|---|---|---|---|
| Grade I | Grade II | Grade III | Grade IV | Grade I | Grade II | Grade III | Grade IV | |
| Haemoglobin | 18 (47.4) | 14 (36.8) | 4 (10.5) | 2 (5.3) | 21 (58.3) | 18 (50.0) | 2 (5.6) | 0 (0) |
| Leukocytes | 21 (55.3) | 17 (44.7) | 15 (13.2) | 0 (0) | 26 (72.2) | 15 (41.7) | 2 (5.6) | 1 (2.8) |
| Neutrophils/granulocytes | 15 (39.5) | 12 (31.6) | 9 (23.7) | 5 (13.2) | 18 (50.0) | 13 (36.1) | 10 (27.8) | 2 (5.6) |
| Platelets | 21 (55.3) | 11 (28.9) | 3 (7.9) | 4 (10.5) | 16 (44.4) | 15 (41.7) | 10 (27.8) | 3 (8.3) |
| Bilirubin | 1 (2.6) | 10 (26.3) | 7 (18.4) | 8 (21.1) | 2 (5.6) | 10 (27.8) | 5 (13.9) | 1 (2.8) |
| AST/ALT | 29 (76.3) | 16 (42.1) | 9 (23.7) | 0 (0) | 27 (75.0) | 10 (27.8) | 2 (5.6) | 0 (0) |
| Alkaline phosphatase | 26 (68.4) | 15 (39.5) | 7 (18.4) | 0 (0) | 24 (66.7) | 9 (25.0) | 4 (11.1) | 0 (0) |
| Nausea | 27 (71.1) | 12 (31.6) | 1 (2.6) | 0 (0) | 28 (77.8) | 16 (44.4) | 3 (8.3) | 0 (0) |
| Diarrhoea | 15 (39.5) | 2 (5.3) | 2 (5.3) | 0 (0) | 13 (36.1) | 6 (16.7) | 0 (0) | 0 (0) |
| Anorexia | 23 (60.5) | 7 (18.4) | 6 (15.8) | 2 (5.3) | 29 (80.6) | 16 (44.4) | 8 (22.2) | 1 (2.8) |
| Oedema | 5 (13.2) | 8 (21.1) | 6 (15.8) | 0 (0) | 6 (16.7) | 7 (19.4) | 3 (8.3) | 0 (0) |
| Dyspnea | 3 (7.9) | 3 (7.9) | 3 (7.9) | 1 (2.6) | 3 (8.3) | 5 (13.9) | 3 (8.3) | 2 (5.6) |
| Sensory neuropathy | 24 (63.2) | 10 (26.3) | 3 (7.9) | 0 (0) | 26 (72.2) | 19 (52.8) | 7 (19.4) | 0 (0) |
| Fatigue | 18 (47.4) | 27 (71.1) | 3 (7.9) | 1 (2.6) | 21 (58.3) | 24 (66.7) | 5 (13.9) | 1 (2.8) |
| Fever | 11 (28.9) | 12 (31.6) | 2 (5.3) | 0 (0) | 9 (25.0) | 10 (27.8) | 3 (8.3) | 0 (0) |
| Infection | 6 (15.8) | 11 (28.9) | 3 (7.9) | 0 (0) | 5 (13.9) | 13 (36.1) | 3 (8.3) | 0 (0) |
| Febrile neutropenia | 0 (0) | 0 (0) | 1 (2.6) | 0 (0) | 0 (0) | 0 (0) | 2 (5.6) | (0) |
Abbreviations: ALT=alanine amino transaminase; AST=aspartate amino transaminase; BDC=bile duct cancer; GBC=gallbladder cancer.
Absolute (and relative, in %) number of patients.