Malignancies reported for the overall safety population
| Indication | Age/ sex | Vedolizumab doses* | Malignancy (PT) | Prior therapy |
|---|---|---|---|---|
| Placebo-controlled studies | ||||
| UC | 70.7/F | 0 | Basal cell carcinoma Squamous cell carcinoma | AZA, 6MP, CS, GLM |
| UC | 40.5/M | 2 | Transitional cell carcinoma | AZA, 6MP, CS† |
| UC | 73.7/M | 2 | Colon cancer | AZA, 6MP, CS |
| UC | 32.7/M | 7 | Colon cancer | AZA†, 6MP, IFX, CS† |
| CD | 45.2/F | 2 | Breast cancer | AZA, 6MP, CS† |
| CD | 52.1/F | 10 | Squamous cell carcinoma | ADA, IFX, AZA, 6MP, MTX, CS |
| CD | 20.7/F | 13 | Carcinoid tumour of the appendix | ADA, IFX, AZA, 6MP, CS |
| Open-label studies | ||||
| UC | 47.4/M | 2 | Malignant melanoma | IFX, AZA†, 6MP, MTX, CS |
| UC | 75.3/F | 3 | Lung neoplasm malignant | AZA, 6MP, IFX, CS |
| UC | 63.5/M | 6 | Breast cancer in situ | MTX, IFX, AZA, CS |
| UC | 44.1/M | 8 | Metastases to peritoneum | IFX, CS, AZA |
| UC | 70.2/M | 9 | Malignant melanoma | IFX, AZA, 6MP, CS |
| UC | 50.4/M | 29 | Renal cancer | CS |
| CD | 69/F | 3 | Lung neoplasm malignant (hepatic neoplasm malignant) | MTX, ADA, IFX, AZA, 6MP, CS† |
| CD | 45.5/F | 8 | Colon cancer | IFX, AZA, 6MP, CS† |
| CD | 46.8/M | 12 | Basal cell carcinoma | IFX, ADA, AZA, 6MP, MTX, CS |
| CD | 42.9/M | 21 | B cell lymphoma | AZA†, 6MP, IFX, CS†, rituximab† |
| CD | 49.7/M | 37 | Squamous cell carcinoma | AZA†, 6MP, CS |
| CD | 51.1/F | 41 | Hepatic neoplasm malignant | ADA, AZA, 6MP, CS |
*Infusions before or on the first occurrence of selected adverse events. For patients who participated in multiple clinical studies, all doses of vedolizumab were counted.
†Continued use on study.
6MP, mercaptopurine; ADA, adalimumab; AZA, azathioprine; CD, Crohn's disease; CS, corticosteroids; GLM, golimumab; IFX, infliximab; MTX, methotrexate; PT, preferred term; UC, ulcerative colitis.