Research Article
An Oral Formulation of the Probiotic, Bacillus subtilis HU58, Was Safe and Well Tolerated in a Pilot Study of Patients with Hepatic Encephalopathy
Table 2
Incidence of treatment-emergent adverse events.
| | | Placebo (N = 11), n (%) | Probiotic (N = 29), n (%) |
| | Patients with at any TEAE | 3 (27.3) | 5 (17.2) | | Mild | 2 (18.2) | 3 (10.3) | | Moderate | 1 (9.1) | 2 (6.9) | | Severe | 0 | 0 | | SAE | 1 (9.1) | 2 (6.9) | | TEAEs leading to permanent discontinuation of the study product | 1 (9.1) | 0 | | Relationship of TEAE with study treatment | | | | Unrelated (/total TEAEs) | 3/6 (50.0) | 5/10 (50.0) | | Unlikely related (/total TEAEs) | 0 | 4/10 (40.0) | | Possibly related (/total TEAEs) | 3/6 (50.0) | 1/10 (10.0) | | Likely related (/total TEAEs) | 0 | 0 | | Deaths | 0 | 0 |
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SAE: serious treatment-emergent adverse event; TEAE: treatment-emergent adverse event.
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