Table 4. Adverse reactions, per-patient-analysis, toxicity grade ⩾3.
|
Gem/Vin toxicity grade ⩾3
|
Gem/Cis toxicity grade ⩾3
|
Gem/Cap toxicity grade ⩾3
|
Gem/Vin vs Gem/Cis | Gem/Vino vs Gem/Cap | Gem/Cis vs Gem/Cap | ||||
|---|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | P-value | P-value | P-value | |
| Haematologic | |||||||||
| Neutropenia | 7 | 16.7 | 2 | 4.4 | 0.07 | 0.004 | 0.49 | ||
| Febrile neutropenia | |||||||||
| Anaemia | 1 | 2.4 | 4 | 8.9 | 1 | 2.0 | 0.36 | 1 | 0.19 |
| Thrombopenia | 2 | 4.8 | 3 | 6.7 | 2 | 4.1 | 1 | 1 | 0.67 |
| Non-haematological | |||||||||
| Alopaecia | |||||||||
| Fatigue | |||||||||
| Nausea | 2 | 4.8 | 2 | 4.4 | 2 | 4.1 | 1 | 1 | 1 |
| Vomiting | 1 | 2.4 | 3 | 6.7 | 3 | 6.1 | 0.62 | 0.62 | 1 |
| Mucositis | |||||||||
| Constipation | |||||||||
| Diarrhoea | 1 | 2.2 | 1 | 1 | 0.47 | ||||
| Infection | |||||||||
| Myalgia | |||||||||
| Sensory neuropathy | |||||||||
| Mot. neuropathy | |||||||||
| Bone pain | 1 | 2.4 | 0.48 | 0.46 | 1 | ||||
| Dyspnoea | 1 | 2.4 | 5 | 11.1 | 2 | 4.1 | 0.20 | 1 | 0.25 |
| Abdominal pain | |||||||||
| Oedema | 1 | 2.0 | 1 | 1 | 1 | ||||
| Rash | |||||||||
| Hand–foot syndr. | 1 | 2.0 | 1 | 1 | 1 | ||||
| Dermatology | 2 | 4.1 | 1 | 0.5 | 0.5 | ||||
| Creatinine | |||||||||
| ALT (GPT) | |||||||||
| AST (GOT) | 3 | 6.1 | 1 | 0.25 | 0.24 | ||||
| AP | 1 | 2.4 | 1 | 2.0 | 0.48 | 1 | 1 | ||
| Bilirubin | 1 | 2.0 | 1 | 0.48 | 1 | ||||
Abbreviations: ALT=alanine transaminase; AP=alkaline phosphatase; AST=aspartate transaminase; GOT=glutamate oxalacitate transaminase; GPT=glutamate pyruvate transaminase; MOT=motoric. P-values are calculated by Fishers exact test.