Table 3.
Summary of treatment-emergent adverse events (safety population).
| Patients, n (%) | Placebo (n = 466) |
Plecanatide 3 mg (n = 467) |
Plecanatide 6 mg (n = 469) |
|---|---|---|---|
| ⩾1 TEAE | 115 (24.7) | 120 (25.7) | 137 (29.2) |
| ⩾1 Severe TEAE | 6 (1.3) | 8 (1.7) | 6 (1.3) |
| ⩾1 Serious AE* | 8 (1.7) | 8 (1.7) | 4 (0.9) |
|
TEAE experienced by ⩾2.0%
of patients in any treatment group |
|||
| Diarrhea | 6 (1.3) | 15 (3.2) | 21 (4.5) |
| Headache | 9 (1.9) | 10 (2.1) | 10 (2.1) |
| Discontinued study medication | |||
| Due to TEAE | 14 (3.0) | 15 (3.2) | 18 (3.8) |
| Due to diarrhea | 2 (0.4) | 5 (1.1) | 5 (1.1) |
*
Four of the 16 serious AEs were pregnancies, as sites were instructed to capture all pregnancies as serious AEs. Pregnancies were reported in each of the treatment groups: two in the placebo group and one each in the plecanatide 3 mg and 6 mg groups; therefore, a total of six (1.3%), seven (1.7%), and three (0.7%) patients with serious AEs were reported for the placebo, plecanatide 3 mg, and plecanatide 6 mg groups, respectively.
AE, adverse event; TEAE, treatment-emergent adverse event.