Table 3 Grade 3/4 adverse events occurring in at least two patients in the safety population
Preferred term | Number of patients | Number (%) patients | ||||
|---|---|---|---|---|---|---|
| Â | LD 5-FU (n = 7) | HD 5-FU (n = 45) | Total (n = 52) | |||
| Â | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 |
Leucopenia | 2 [2] | 0 | 8 [8] | [1] | 10 (19) | 1 (2) |
Diarrhoea | 0 | 0 | 6 [5] | 0 | 6 (12) | 0 (0) |
Vomiting | 1 [1] | 0 | 5 [3] | 0 | 6 (12) | 0 (0) |
Rash | 2 [2] | 0 | 4 [4] | 0 | 6 (12) | 0 (0) |
Acne | 2 [2] | 0 | 3 [3] | 0 | 5 (10) | 0 (0) |
Asthenia | 2 [2] | 0 | 3 [1] | 1 | 5 (10) | 1 (2) |
Intestinal obstruction | 0 | 0 | 4 | 1 | 4 (8) | 1 (2) |
Abdominal pain | 0 | 0 | 3 | 0 | 3 (6) | 0 (0) |
Mucous membrane disorder | 0 | 0 | 3 [3] | 0 | 3 (6) | 0 (0) |
Dyspnoea | 0 | 0 | 3 [3] | 1 | 3 (6) | 1 (2) |
Atrial fibrillation | 0 | 0 | 2 | 0 | 2 (4) | 0 (0) |
Deep thrombophlebitis | 0 | 0 | 2 [1] | 0 | 2 (4) | 0 (0) |
Gamma glutamyl transpeptidase increased | 0 | 0 | 2 [1] | 0 | 2 (4) | 0 (0) |
Hypokalaemia | 0 | 0 | 2 | 0 | 2 (4) | 0 (0) |
Liver function test abnormal | 0 | 0 | 2 [1] | 0 | 2 (4) | 0 (0) |
Skin disorder | 0 | 0 | 2 [2] | 0 | 2 (4) | 0 (0) |
Thrombosis | 0 | 0 | 2 | 0 | 2 (4) | 0 (0) |
Urinary tract infection | 0 | 0 | 2 | 0 | 2 (4) | 0 (0) |
Weight loss | 0 | 0 | 2 [1] | 0 | 2 (4) | 0 (0) |