Table 2 Reported adverse events in study participants
Adverse events | Full analysis set (n = 74) | Discontinued (n = 15) | All (n = 89) | ||||||
|---|---|---|---|---|---|---|---|---|---|
Placebo (n = 39) | BSE (n = 35) | Total (n = 74) | Placebo (n = 6) | BSE (n = 9) | Total (n = 15) | Placebo (n = 45) | BSE (n = 44) | Total (n = 89) | |
Nausea | 3 | 3 | 2 | 2 | 5 | 5 | |||
Loose stools | 6 | 6 | 1 | 2 | 3 | 1 | 8 | 9 | |
Diarrhoea | 1 | 1 | 2 | 1 | 3 | 4 | 2 | 4 | 6 |
Vomiting | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 3 | |
Gastro-intestinal reflux | 1 | 1 | 2 | 1 | 1 | 2 | |||
Lower urinary tract infection | 1 | 1 | 1 | 1 | |||||
Upper urinary tract infection | 1 | 1 | 1 | 1 | |||||
Pneumonia | 1 | 1 | 1 | 1 | |||||
Upper respiratory tract infection | 3 | 5 | 8 | 1 | 1 | 2 | 4 | 6 | 10 |
Dry mouth | 1 | 1 | 1 | 1 | |||||
Fainting | 1 | 1 | 1 | 1 | |||||
Tooth infection | 1 | 1 | 1 | 1 | |||||
Hot flush | 1 | 1 | 1 | 1 | |||||
Skin symptoms | 1 | 1 | 1 | 1 | |||||
Skeletal pain | 3 | 2 | 5 | 3 | 2 | 5 | |||
Gout | 1 | 1 | 1 | 1 | |||||