Table 3.

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)

Data are presented as n (%).

^*MedDRA (version 21.0) terms were used for coding AEs.

^†Participants with 1 or more events within a level of MedDRA term are counted only once in that level.

^‡Investigator reported this event as “CMV reactivation.”