Table 1.
Summary of treatment-emergent adverse events (safety population) for the study by Miner and colleagues [ClinicalTrials.gov identifier: NCT01982240].3
| Placebo (n = 458) n (%) |
Plecanatide 3 mg (n = 474) n (%) |
Plecanatide 6 mg (n = 457) n (%) |
|
|---|---|---|---|
| Patients with at least one TEAE | 150 (32.8) | 168 (35.4) | 151 (33.0) |
| Patients with at least one severe TEAE | 7 (1.5) | 13 (2.7) | 17 (3.7) |
| Patients with at least one TEAE leading to discontinuation | 6 (1.3) | 24 (5.1) | 24 (5.3) |
| TEAEs with incidence of >2% of plecanatide patients | |||
| Diarrhea | 6 (1.3) | 28 (5.9) | 26 (5.7) |
| Nasopharyngitis | 8 (1.7) | 4 (0.8) | 11 (2.4) |
| Sinusitis | 3 (0.7) | 10 (2.1) | 3 (0.7) |
TEAE, treatment-emergent adverse event.