Table 3. Adverse events and adverse events leading to discontinuation (safety population).
| Adverse event (preferred term)a | Placebo (N=401), n (%) | Linaclotide |
|
|---|---|---|---|
| 72 μg (N=411), n (%) | 145 μg (N=411), n (%) | ||
| Patients with at least 1 AE | 107 (26.7) | 143 (34.8) | 145 (35.3) |
| Diarrhea | 28 (7.0) | 79 (19.2) | 91 (22.1) |
| Abdominal distension | 2 (0.5) | 9 (2.2) | 5 (1.2) |
| Sinusitis | 1 (0.2) | 4 (1.0) | 8 (1.9) |
| Upper respiratory tract infection | 5 (1.2) | 6 (1.5) | 6 (1.5) |
| Flatulence | 5 (1.2) | 6 (1.5) | 3 (0.7) |
| Nasopharyngitis | 2 (0.5) | 2 (0.5) | 6 (1.5) |
| Patients with at least 1 AE leading to discontinuation | 2 (0.5) | 12 (2.9) | 19 (4.6) |
| Diarrhea | 0 | 10 (2.4) | 13 (3.2) |
AE, adverse event; n, number of patients with AEs.
Patients were counted only once within each preferred term.
a
Treatment-emergent adverse events (TEAEs) reported in ≥1% of patients in either linaclotide dose group and at an incidence greater than reported in placebo-treated patients during the treatment period.