Frequency of drug-related TEAEs, by dose cohort and system organ class
| Category of event* . | Vedolizumab 75 mg (n = 3) . | Vedolizumab 300 mg (n = 21) . | Total (N = 24) . |
|---|---|---|---|
| Participants with any drug-related TEAE† | 2 (66.7) | 6 (28.6) | 8 (33.3) |
| Blood and lymphatic system disorders | |||
| Total | 0 (0) | 2 (9.5) | 2 (8.3) |
| Anemia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Febrile neutropenia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Nervous system disorders | |||
| Total | 0 (0) | 2 (9.5) | 2 (8.3) |
| Headache | 0 (0) | 1 (4.8) | 1 (4.2) |
| Cognitive disorder | 0 (0) | 1 (4.8) | 1 (4.2) |
| Musculoskeletal and connective tissue disorders | |||
| Total | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Arthralgia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Musculoskeletal pain | 1 (33.3) | 0 (0) | 1 (4.2) |
| Investigations | |||
| Total | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Alanine aminotransferase increased | 1 (33.3) | 0 (0) | 1 (4.2) |
| Aspartate aminotransferase increased | 0 (0) | 1 (4.8) | 1 (4.2) |
| Infections and infestations | |||
| CMV infection‡ | 0 (0) | 1 (4.8) | 1 (4.2) |
| Vascular disorders | |||
| Hypotension | 0 (0) | 1 (4.8) | 1 (4.2) |
| Respiratory, thoracic, and mediastinal disorders | |||
| Dyspnea exertional | 0 (0) | 1 (4.8) | 1 (4.2) |
| Skin and subcutaneous tissue disorders | |||
| Rash pruritic | 0 (0) | 1 (4.8) | 1 (4.2) |
| General disorders and administration site conditions | |||
| Pyrexia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Participants with at least 1 serious drug-related TEAE | 0 (0) | 1 (4.8) | 1 (4.2) |
| Blood and lymphatic system disorders | |||
| Febrile neutropenia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Vascular disorders | |||
| Hypotension | 0 (0) | 1 (4.8) | 1 (4.2) |
| Category of event* . | Vedolizumab 75 mg (n = 3) . | Vedolizumab 300 mg (n = 21) . | Total (N = 24) . |
|---|---|---|---|
| Participants with any drug-related TEAE† | 2 (66.7) | 6 (28.6) | 8 (33.3) |
| Blood and lymphatic system disorders | |||
| Total | 0 (0) | 2 (9.5) | 2 (8.3) |
| Anemia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Febrile neutropenia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Nervous system disorders | |||
| Total | 0 (0) | 2 (9.5) | 2 (8.3) |
| Headache | 0 (0) | 1 (4.8) | 1 (4.2) |
| Cognitive disorder | 0 (0) | 1 (4.8) | 1 (4.2) |
| Musculoskeletal and connective tissue disorders | |||
| Total | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Arthralgia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Musculoskeletal pain | 1 (33.3) | 0 (0) | 1 (4.2) |
| Investigations | |||
| Total | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Alanine aminotransferase increased | 1 (33.3) | 0 (0) | 1 (4.2) |
| Aspartate aminotransferase increased | 0 (0) | 1 (4.8) | 1 (4.2) |
| Infections and infestations | |||
| CMV infection‡ | 0 (0) | 1 (4.8) | 1 (4.2) |
| Vascular disorders | |||
| Hypotension | 0 (0) | 1 (4.8) | 1 (4.2) |
| Respiratory, thoracic, and mediastinal disorders | |||
| Dyspnea exertional | 0 (0) | 1 (4.8) | 1 (4.2) |
| Skin and subcutaneous tissue disorders | |||
| Rash pruritic | 0 (0) | 1 (4.8) | 1 (4.2) |
| General disorders and administration site conditions | |||
| Pyrexia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Participants with at least 1 serious drug-related TEAE | 0 (0) | 1 (4.8) | 1 (4.2) |
| Blood and lymphatic system disorders | |||
| Febrile neutropenia | 0 (0) | 1 (4.8) | 1 (4.2) |
| Vascular disorders | |||
| Hypotension | 0 (0) | 1 (4.8) | 1 (4.2) |