Table 2.
Overall summary of TEAEs and TESAEs according to severity and discontinuation of treatment.
| Parameter | RCT teduglutide group, n = 109 |
RCT/extension teduglutide group, n = 173 |
RCT placebo group, n = 59 |
|||
|---|---|---|---|---|---|---|
| n (%) | Number of events | n (%) | Number of events | n (%) | Number of events | |
| Any TEAE | 99 (90.8) | 778 | 167 (96.5) | 2235 | 49 (83.1) | 372 |
| TEAE severity | ||||||
| Mild | 84 (77.1) | 441 | 151 (87.3) | 1179 | 45 (76.3) | 184 |
| Moderate | 74 (67.9) | 268 | 140 (80.0) | 849 | 34 (57.6) | 145 |
| Severe | 31 (28.4) | 69 | 83 (48.0) | 207 | 16 (27.1) | 43 |
| Any TESAE | 39 (35.8) | 80 | 101 (58.4) | 259 | 17 (28.8) | 34 |
| TESAE severity | ||||||
| Mild | 13 (11.9) | 17 | 29 (16.8) | 47 | 5 (8.5) | 6 |
| Moderate | 18 (16.5) | 28 | 59 (34.1) | 114 | 7 (11.9) | 9 |
| Severe | 16 (14.7) | 35 | 56 (32.4) | 98 | 8 (13.6) | 19 |
| TEAE leading to discontinuation | 10 (9.2) | 17 | 34 (19.7) | 52 | 4 (6.8) | 5 |
| AEs leading to death | 0 | 0 | 3 (1.7) | 3 | 0 | 0 |
AE, adverse event; RCT, randomized controlled trial; TEAE, treatment-emergent AE; TESAE, treatment-emergent serious AE.