Table 2.

Summary of treatment-emergent adverse events considered possibly related to study treatment with prolonged-release tacrolimus

	Number of adverse events
Adverse event*	Intact capsule (oral) (n=20)	Suspension (oral) (n=20)	Suspension (nasogastric tube) (n=20)
Participants, n (%)	4 (20)	2 (10)	7 (35)
Events, n	5	3	9
Mild	4	3	5
Moderate	1	0	4
Severe	0	0	0
Eye disorders
Eye pain	0 (0)	0 (0)	1 (1)
Gastrointestinal disorders
Diarrhoea not otherwise specified	0 (0)	0 (0)	1 (1)
Nausea	1 (1)	0 (0)	0 (0)
Toothache	0 (0)	0 (0)	1 (1)
General disorders and administration site conditions
Fatigue	0 (0)	0 (0)	1 (1)
Infections and infestations
Herpes simplex	0 (0)	0 (0)	1 (1)
Upper respiratory tract infection	0 (0)	1 (1)	0 (0)
Musculoskeletal and connective tissue disorders
Back pain	0 (0)	0 (0)	1 (1)
Nervous system disorders
Headache	1 (1)	0 (0)	1 (1)
Dizziness	1 (1)	0 (0)	0 (0)
Dysgeusia	0 (0)	1 (1)	0 (0)
Paraesthesia	1 (1)	0 (0)	0 (0)
Respiratory, thoracic and mediastinal disorders
Throat irritation	0 (0)	1 (1)	1 (1)
Nasopharyngitis	1 (1)	0 (0)	0 (0)
Skin and subcutaneous tissue disorders
Rash maculopapular	0 (0)	0 (0)	1 (1)

*Adverse event with possible, probable or definite relationship to study drug. Adverse events presented as number of adverse events (number of participants with adverse event) unless otherwise specified.