Table 2 Adverse events.
AEs, n (%) | 1 × 108 CFU n = 6 | 1 × 109 CFU n = 20 | Total n = 26 |
|---|---|---|---|
Any AEs | 6 (100) | 20 (100) | 26 (100) |
Related AEs | 6 (100) | 20 (100) | 26 (100) |
Grade ≥3 AEs | 5 (83) | 13 (65) | 18 (69) |
Related grade ≥3 AEs | 3 (50) | 8 (40) | 11 (42) |
Serious AEs | 2 (33) | 5 (25) | 7 (27) |
Related serious AEs | 0 | 1 (5) | 1 (4) |
Grade ≥3 serious AEs | 2 (33) | 4 (20) | 6 (23) |
AEs leading to treatment discontinuation | 0 | 1 (5) | 1 (4) |
Most common AEs (≥20% of total), n (%) | |||
Chills | 5 (83) | 19 (95) | 24 (92) |
Pyrexia | 5 (83) | 16 (80) | 21 (81) |
Fatigue | 4 (67) | 12 (60) | 16 (62) |
Nausea | 3 (50) | 9 (45) | 12 (46) |
Vomiting | 2 (33) | 9 (45) | 11 (42) |
Anemia | 4 (67) | 7 (35) | 11 (42) |
Arthralgia | 3 (50) | 7 (35) | 10 (39) |
Decreased appetite | 1 (17) | 7 (35) | 8 (31) |
Constipation | 3 (50) | 4 (20) | 7 (27) |
Back pain | 2 (33) | 5 (25) | 7 (27) |
Lymphopenia | 1 (17) | 6 (30) | 7 (27) |
Hypertension | 1 (17) | 6 (30) | 7 (27) |
Diarrhea | 3 (50) | 3 (15) | 6 (23) |
Headache | 1 (17) | 5 (25) | 6 (23) |
