Table 3.
Summary of adverse events.
| CD [n = 88] | UC [n = 79] | Total [n = 167] | ||||
|---|---|---|---|---|---|---|
| Events, n | Patients, n [%] | Events, n | Patients, n [%] | Events, n | Patients, n [%] | |
| Any AEs | 55 | 32 [36.4] | 49 | 25 [31.6] | 104 | 57 [34.1] |
| Related to treatmenta | 2 | 2 [2.3] | 1 | 1 [1.3] | 3 | 3 [1.8] |
| Not related to treatment | 53 | 30 [34.1] | 48 | 24 [30.4] | 101 | 54 [32.3] |
| Mild | 25 | 15 [17.0] | 31 | 14 [17.7] | 56 | 29 [17.4] |
| Moderate | 28 | 15 [17.0] | 16 | 10 [12.7] | 44 | 25 [15.0] |
| Severe | 2 | 2 [2.3] | 2 | 1 [1.3] | 4 | 3 [1.8] |
| Serious AEs | 3 | 3 [3.4] | 2 | 2 [2.5] | 5 | 5 [3.0] |
| Related to treatment | 0 | 0 | 0 | 0 | 0 | 0 |
| Not related to treatment | 3 | 3 [3.4] | 2 | 2 [2.5] | 5 | 5 [3.0] |
| Leading to treatment discontinuation | 0 | 0 | 1 | 1 [1.3] | 1 | 1 [0.6] |
| Deaths | – | 0 | – | 0 | – | 0 |
AE, adverse event; CD, Crohn’s disease; UC, ulcerative colitis.
a Treatment-related AEs included pharyngitis and worsening of CD [one patient each, CD] and proctitis [one patient, UC].