Exposure-adjusted incidence rates of serious infections 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 serious infection or infestation†† | 4 | 5.0 (0.1 to 10.0) | 54 | 2.7 (1.9 to 3.4) | 4 | 3.0 (0.1 to 6.0) | 145 | 5.6 (4.6 to 6.5) | 8 | 3.8 (1.2 to 6.4) | 199 | 4.3 (3.7 to 4.9) |
| Serious infections of interest | ||||||||||||
| Gastroenteritis (PT) | 0 | 0.0 (0.0 to 3.7) | 3 | 0.1 (0.0 to 0.3) | 0 | 0.0 (0.0 to 2.3) | 14 | 0.5 (0.2 to 0.8) | 0 | 0.0 (0.0 to 1.4) | 17 | 0.4 (0.2 to 0.5) |
| Abscess‡‡ | 2 | 2.5 (0.0 to 6.0) | 3 | 0.1 (0.0 to 0.3) | 1 | 0.8 (0.0 to 2.2) | 65 | 2.4 (1.8 to 3.0) | 3 | 1.4 (0.0 to 3.0) | 68 | 1.4 (1.1 to 1.8) |
| Clostridial infections | 0 | 0.0 (0.0 to 3.7) | 7 | 0.3 (0.1 to 0.6) | 0 | 0.0 (0.0 to 2.3) | 8 | 0.3 (0.1 to 0.5) | 0 | 0.0 (0.0 to 1.4) | 15 | 0.3 (0.2 to 0.5) |
| Candida, tinea and other fungal infections§§ | 0 | 0.0 (0.0 to 3.7) | 1 | <0.1 (0.0 to 0.1) | 0 | 0.0 (0.0 to 2.3) | 2 | 0.1 (0.0 to 0.2) | 0 | 0.0 (0.0 to 1.4) | 3 | 0.1 (0.0 to 0.1) |
| Sepsis and related terms¶¶ | 1 | 1.2 (0.0 to 3.7) | 4 | 0.2 (0.0 to 0.4) | 1 | 0.8 (0.0 to 2.2) | 7 | 0.3 (0.1 to 0.4) | 2 | 0.9 (0.0 to 2.2) | 11 | 0.2 (0.1 to 0.4) |
| Tuberculosis | 0 | 0.0 (0.0 to 3.7) | 1 | <0.1 (0.0 to 0.1) | 0 | 0.0 (0.0 to 2.3) | 3 | 0.1 (0.0 to 0.2) | 0 | 0.0 (0.0 to 1.4) | 4 | 0.1 (0.0 to 0.2) |
| Cytomegalovirus infections | 0 | 0.0 (0.0 to 3.7) | 2 | 0.1 (0.0 to 0.2) | 0 | 0.0 (0.0 to 2.3) | 1 | <0.1 (0.0 to 0.1) | 0 | 0.0 (0.0 to 1.4) | 3 | 0.1 (0.0 to 1.4) |
| Meningitis (PT) | 0 | 0 | 0 | 0 | 0 | 0.0 (0.0 to 2.3) | 1 | <0.1 (0.0 to 0.1) | 0 | 0.0 (0.0 to 1.4) | 1 | <0.1 (0.0 to 0.1) |
| Salmonella infections | 0 | 0.0 (0.0 to 3.7) | 1 | <0.1 (0.0 to 0.1) | 0 | 0.0 (0.0 to 2.3) | 1 | <0.1 (0.0 to 0.1) | 0 | 0.0 (0.0 to 1.4) | 2 | <0.1 (0.0 to 0.1) |
Adverse events are listed according to the MedDRA high-level term unless otherwise indicated. Exposure-adjusted incidence rates for each adverse event (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 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). Infections occurring in ≥0.5 patients per 100 PYs in any patient group are shown.
*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 all MedDRA preferred terms listed under the ‘Infections and Infestations’ system organ class.
‡‡Includes MedDRA preferred terms: anal abscess, perirectal abscess, rectal abscess, rectovaginal septum abscess, abdominal abscess, abscess intestinal, abscess, perineal abscess, pelvic abscess.
§§Includes MedDRA high-level terms: Candida infections, fungal infections NEC, tinea infections.
¶¶Includes all MedDRA preferred terms listed under the ‘Sepsis, bacteraemia, viraemia and fungemia NEC’ high-level term.
CD, Crohn's disease; LTS, long-term safety; MedDRA, Medical Dictionary for Regulatory Activities; NEC, not elsewhere classified; PT, preferred term; PY, person-year; UC, ulcerative colitis.