Table 4 Clinical adverse events in the per protocol population
ASAQ (number of patients) | AL (number of patients) | P | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
D0 | D1 | D2 | D3 | D7 | Total | % | D0 | D1 | D2 | D3 | D7 | Total | % | ||
Adverse effects | 129 | 125 | 123 | 119 | 114 | – | 133 | 132 | 130 | 125 | 126 | – | |||
Fatigue | 2 | 18 | 19 | 25 | 1 | 65 | 10.7 | 3 | 14 | 12 | 5 | 4 | 38 | 5.9 | 0.02 |
Anorexia | 3 | 1 | 1 | 2 | 2 | 9 | 1.5 | 0 | 1 | 1 | 2 | 1 | 5 | 0.8 | 0.2 |
Vomiting | 8 | 10 | 4 | 4 | 2 | 28 | 4.6 | 11 | 9 | 5 | 0 | 1 | 26 | 4.0 | 0.6 |
Abdominal pain | 3 | 6 | 4 | 4 | 2 | 19 | 3.1 | 2 | 2 | 2 | 3 | 5 | 14 | 2.2 | 0.3 |
Diarrhoea | 2 | 3 | 4 | 0 | 2 | 11 | 1.8 | 9 | 2 | 1 | 0 | 0 | 12 | 1.9 | 0.9 |
Nausea | 0 | 3 | 1 | 2 | 0 | 6 | 1 | 0 | 0 | 1 | 0 | 1 | 2 | 0.3 | 0.2 |
Headache | 3 | 3 | 1 | 0 | 2 | 9 | 1.5 | 0 | 2 | 2 | 2 | 2 | 8 | 1.2 | 0.7 |
Jaundice | 0 | 1 | 0 | 2 | 4 | 7 | 1.1 | 1 | 0 | 0 | 1 | 1 | 3 | 0.5 | 0.3 |
Dizziness | 0 | 1 | 3 | 3 | 0 | 7 | 1.1 | 0 | 0 | 1 | 1 | 0 | 2 | 0.3 | 0.1 |
Pruritus | 0 | 0 | 2 | 1 | 1 | 4 | 0.7 | 0 | 0 | 1 | 0 | 0 | 1 | 0.2 | 0.3 |
Rashes | 0 | 0 | 0 | 0 | 1 | 1 | 0.2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | – |