Table 4. CTC grade 3 and 4 toxicities.
|
Regardless of causality
|
Possibly related to therapy
|
|||
|---|---|---|---|---|
| CTC Group | Grade 3 (N=41) | Grade 4 (N=41) | Grade 3 (N=41) | Grade 4 (N=41) |
| Overall | 23 (56.1%) | 7 (17.1%) | 16 (39.0%) | 4 (9.8%) |
| Blood/bone marrow | 14 (34.1%) | 3 (7.3%) | 12 (29.3%) | 3 (7.3%) |
| Haemoglobin | 1 (2.4%) | 1 (2.4%) | 1 (2.4%) | 1 (2.4%) |
| Leukocytes | 9 (22.0%) | 1 (2.4%) | 9 (22.0%) | 1 (2.4%) |
| Neutrophils/granulocytes | 10 (24.4%) | 2 (4.9%) | 8 (19.5%) | 2 (4.9%) |
| Platelets | 3 (7.3%) | 0 | 3 (7.3%) | 0 |
| Gastrointestinal | 13 (31.7%) | 2 (4.9%) | 5 (12.2%) | 0 |
| Anorexia | 1 (2.4%) | 0 | 1 (2.4%) | 0 |
| Ascites | 1 (2.4%) | 0 | 0 | 0 |
| Constipation | 4 (9.8%) | 0 | 1 (2.4%) | 0 |
| Dehydration | 2 (4.9%) | 0 | 2 (4.9%) | 0 |
| Diarrhoea without colostomy | 1 (2.4%) | 0 | 0 | 0 |
| Dyspepsia/heartburn | 1 (2.4%) | 0 | 0 | 0 |
| Gastritis | 1 (2.4%) | 0 | 0 | 0 |
| Nausea | 5 (12.2%) | 0 | 3 (7.3%) | 0 |
| Vomiting | 3 (7.3%) | 0 | 2 (4.9%) | 0 |
| Other gastrointestinal | 4 (9.8%) | 2 (4.9%) | 0 | 0 |
| Hepatic | 3 (7.3%) | 2 (4.9%) | 1 (2.4%) | 0 |
| Alkaline phosphatase | 4 (9.8%) | 0 | 0 | 0 |
| Bilirubin | 1 (2.4%) | 1 (2.4%) | 0 | 0 |
| GGT | 1 (2.4%) | 0 | 0 | 0 |
| AST | 2 (4.9%) | 1 (2.4%) | 1 (2.4%) | 0 |
| ALT | 1 (2.4%) | 1 (2.4%) | 0 | 0 |
| Infection/febrile neutropaenia | 2 (4.9%) | 1 (2.4%) | 0 | 1 (2.4%) |
| Metabolic/laboratory | 8 (19.5%) | 2 (4.9%) | 0 | 0 |
| Hyperglycaemia | 8 (19.5%) | 2 (4.9%) | 0 | 0 |
| Pain | 7 (17.1%) | 0 | 1 (2.4%) | 0 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, γ-glutamyl transpeptidase.
Patients who reported more than one toxicity are counted more than once in this table. Relatedness should be treated with caution because some study sites interpreted ‘therapy’ to mean only gemcitabine.
Other categories (regardless of causality): cardiovascular (general) (n=5): hypertension (two patients), thrombosis (2), and other cardiovascular/general (1); constitutional symptoms (n=2): fatigue (1) and weight loss (1); endocrine (n=1): other endocrine (1); haemorrhage (n=1): melena/gastrointestinal bleeding (1); neurology (n=2): CNS cerebrovascular ischaemia (1) and mood alteration-depression (1); pulmonary (n=3): dyspnea (1) and pulmonary-other (2); renal/genitourinary (n=1): urinary frequency/urgency (1). All of these were grade 3 toxicities.