Most frequent adverse events (⩾1% in any group), regardless of study drug relation
First treatment | Repeated treatment* | |||
---|---|---|---|---|
Tegaserod (n = 2132), n (%) | Placebo (n = 525), n (%) | Tegaserod (n = 487), n (%) | Placebo (n = 494), n (%) | |
*Includes only first treatment tegaserod patients who received repeated treatment. | ||||
†p<0.0001, tegaserod v placebo using Fisher’s exact test (post hoc). | ||||
‡p = 0.04, tegaserod v placebo using Fisher’s exact test (post hoc). | ||||
Headache | 118 (5.5) | 26 (5.0) | 20 (4.1) | 18 (3.6) |
Diarrhoea | 81 (3.8)† | 3 (0.6) | 9 (1.8)‡ | 2 (0.4) |
Abdominal pain | 48 (2.3) | 13 (2.5) | 5 (1.0) | 6 (1.2) |
Nausea | 47 (2.2) | 6 (1.1) | 2 (0.4) | 2 (0.4) |
Nasopharyngitis | 46 (2.2) | 8 (1.5) | 6 (1.2) | 5 (1.0) |
Influenza | 24 (1.1) | 7 (1.3) | 1 (0.2) | 2 (0.4) |
Abdominal pain upper | 23 (1.1) | 3 (0.6) | 3 (0.6) | 2 (0.4) |
Back pain | 20 (0.9) | 8 (1.5) | 5 (1.0) | 5 (1.0) |
Dyspepsia | 11 (0.5) | 5 (1.0) | 2 (0.4) | 2 (0.4) |
Urinary tract infection | 11 (0.5) | 6 (1.1) | 5 (1.0) | 3 (0.6) |
Dysmenorrhoea | 11 (0.5) | 3 (0.6) | 2 (0.4) | 5 (1.0) |