Exposure-adjusted incidence rates of adverse events in the overall safety population
| Adverse event | UC | CD | UC and CD | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo n=149* | Vedolizumab n=1107† | Placebo n=355‡ | Vedolizumab n=1723§ | Placebo n=504¶ | Vedolizumab n=2830** | |||||||
| No. of patients with event | No. of patients with event/100 PY (95% CI) | No. of patients with event | No. of patients with event/100 PY (95% CI) | No. of patients with event | No. of patients with event/100 PY (95% CI) | No. of patients with event | No. of patients with event/100 PY (95% CI) | No. of patients with event | No. of patients with event/100 PY (95% CI) | No. of patients with event | No. of patients with event/100 PY (95% CI) | |
| Any AE | 114 | 351.6 (269.6 to 433.7) | 973 | 198.4 (175.1 to 221.7) | 241 | 461.5 (378.4 to 544.6) | 1576 | 292.8 (266.8 to 318.7) | 355 | 419.4 (359.3 to 479.5) | 2549 | 247.8 (229.8 to 265.8) |
| Any SAE | 17 | 22.6 (11.6 to 33.6) | 258 | 13.7 (11.9 to 15.4) | 39 | 31.8 (21.5 to 42.0) | 584 | 25.1 (22.9 to 27.4) | 56 | 28.3 (20.6 to 35.9) | 842 | 20.0 (18.5 to 21.5) |
| Common AEs (≥10 patients with events/100 PY in any patient group) | ||||||||||||
| Nasopharyngitis | 11 | 13.9 (5.5 to 22.4) | 226 | 13.1 (11.3 to 14.9) | 18 | 14.1 (7.5 to 20.8) | 315 | 13.8 (12.2 to 15.4) | 29 | 14.1 (8.8 to 19.3) | 541 | 13.5 (12.3 to 14.7) |
| Abdominal pain†† | 10 | 13.2 (4.9 to 21.5) | 138 | 7.3 (6.0 to 8.5) | 31 | 25.3 (16.4 to 34.2) | 367 | 16.0 (14.3 to 17.7) | 41 | 20.7 (14.3 to 27.1) | 505 | 12.1 (11.0 to 13.2) |
| Headache | 13 | 17.1 (7.5 to 26.7) | 172 | 9.6 (8.0 to 11.1) | 34 | 27.9 (18.1 to 37.8) | 299 | 13.0 (11.4 to 14.6) | 47 | 23.7 (16.7 to 30.8) | 471 | 11.5 (10.4 to 12.6) |
| Arthralgia | 10 | 13.0 (4.9 to 21.2) | 151 | 8.2 (6.8 to 9.5) | 29 | 23.1 (14.6 to 31.5) | 314 | 13.7 (12.1 to 15.3) | 39 | 19.3 (13.2 to 25.4) | 465 | 11.2 (10.1 to 12.3) |
| Upper respiratory tract infection | 23 | 30.7 (17.7 to 43.7) | 159 | 8.6 (7.2 to 10.0) | 44 | 37.2 (25.8 to 48.6) | 175 | 7.0 (5.9 to 8.0) | 24 | 11.6 (6.9 to 16.3) | 334 | 7.7 (6.8 to 8.5) |
| Nausea | 11 | 14.3 (5.8 to 22.7) | 95 | 4.8 (3.8 to 5.8) | 16 | 12.6 (6.2 to 19.0) | 230 | 9.5 (8.2 to 10.8) | 27 | 13.2 (8.1 to 18.3) | 325 | 7.4 (6.6 to 8.3) |
| Pyrexia | 5 | 6.3 (0.7 to 11.8) | 78 | 3.9 (3.0 to 4.8) | 30 | 23.8 (15.1 to 32.6) | 232 | 9.4 (8.2 to 10.7) | 35 | 17.0 (11.3 to 22.8) | 310 | 7.0 (6.2 to 7.8) |
| Vomiting | 6 | 7.6 (1.5 to 13.6) | 51 | 2.5 (1.8 to 3.2) | 15 | 11.7 (5.8 to 17.7) | 177 | 7.0 (6.0 to 8.1) | 21 | 10.1 (5.8 to 14.5) | 228 | 5.0 (4.4 to 5.7) |
| Anaemia | 11 | 14.3 (5.7 to 22.9) | 91 | 4.6 (3.7 to 5.6) | 10 | 7.7 (2.9 to 12.5) | 98 | 3.7 (3.0 to 4.5) | 21 | 10.2 (5.8 to 14.6) | 189 | 4.1 (3.5 to 4.7) |
| Exacerbation of CD | N/A | N/A | N/A | N/A | 57 | 47.3 (34.4 to 60.2) | 486 | 20.4 (18.5 to 22.4) | 57 | 47.3 (34.4 to 60.2) | N/A | N/A |
| Exacerbation of UC | 29 | 38.2 (24.2 to 52.1) | 290 | 15.5 (13.6 to 17.4) | N/A | N/A | N/A | N/A | 29 | 38.2 (24.2 to 52.1) | N/A | N/A |
Exposure-adjusted incidence rates for each AE were calculated by dividing the number of patients experiencing the event by the total PYs, multiplied by 100. PYs were calculated as the sum of each patient's contribution, calculated from the days of exposure (ie, AE onset date minus the date of first dose plus 1 day). For each AE, the PYs were truncated after a patient experienced the AE and each AE was counted only once per patient. Patients who were randomised to placebo and then rolled over into an open-label study could contribute to events in either the placebo or vedolizumab group depending on when they experienced the AE. PYs were calculated accordingly for placebo or vedolizumab for each AE. When the number of events=0, the 95% CI was calculated based on rule of 3 (ie, (0, 3/total PYs)×100).
*Includes patients from GEMINI 1.
†Includes patients from studies C13002, C13004, GEMINI 1 and GEMINI LTS.
‡Includes patients from GEMINI 2 and GEMINI 3.
§Includes patients from studies C13004, GEMINI 2, GEMINI 3 and GEMINI LTS.
¶Includes patients from GEMINI 1, GEMINI 2 and GEMINI 3.
**Includes patients from all six studies.
††Includes MedDRA preferred terms: abdominal pain, abdominal pain lower, abdominal rebound tenderness, abdominal rigidity, abdominal tenderness, abdominal pain upper, GI pain.
AE, adverse event; CD, Crohn's disease; LTS, long-term safety; MedDRA, Medical Dictionary for Regulatory Activities; N/A, not applicable; PY, person-year; SAE, serious adverse event; UC, ulcerative colitis.