Table 5 Safety analysis
| Â | Total | Low-dose | Intermediate-dose | High-dose |
|---|---|---|---|---|
AE occurrence, n (%) | ||||
 Yes | 106 (25.8) | 5 (18.5) | 81 (25.4) | 20 (30.8) |
 No | 281 (68.4) | 18 (66.7) | 220 (69) | 43 (66.2) |
 Unknown | 24 (5.8) | 4 (14.8) | 18 (5.6) | 2 (3.1) |
Type of AE, n (%) | ||||
 Digestive | 51 (48.1) | 2 (40) | 36 (44.4) | 12 (60) |
 Hepatic | 12 (11.3) | 2 (40) | 11 (13.6) | 0 (0) |
 Cutaneous | 11 (10.4) | 0 (0) | 8 (9.9) | 2 (10) |
 Renal | 3 (2.8) | 0 (0) | 2 (2.5) | 1 (5) |
 Hematological | 2 (1.9) | 0 (0) | 2 (2.5) | 0 (0) |
 General | 1 (0,94) | 0 (0) | 1 (1,2) | 0 (0) |
 Neurologic | 1 (0,94) | 0 (0) | 1 (1,2) | 0 (0) |
  > 1 AE types | 23 (21,8) | 1 (20) | 17 (20,9) | 4 (20) |
 Not specified | 1 (0,94) | 0 (0) | 1 (1,2) | 1 (5) |
 Unknown | 1 (0,94) | 0 (0) | 2 (2,5) | 0 (0) |
AE severity grade, n (%) | ||||
 I – II | 75 (70.8) | 3 (60) | 53 (65.4) | 16 (80) |
 III – IV | 15 (14.2) | 2 (40) | 10 (12.3) | 2 (10) |
 Unknown | 16 (15) | 0 (0) | 18 (22.2) | 2 (10) |
AE consequences on patient management | ||||
 Antibiotic change | 62 (58.5) | 5 (100) | 50 (61.7) | 7 (35) |
 Rifampicin continuation | 32 (30.2) | 0 (0) | 20 (24.7) | 11 (55) |
 Galenic change | 6 (5.7) | 0 (0) | 4 (4.9) | 2 (10) |
 Dosage decrease | 2 (1.9) | 0 (0) | 2 (2.5) | 0 (0) |
 Antibiotic discontinuation | 4 (3.8) | 0 (0) | 4 (4.9) | 0 (0) |
 Unknown | 0 (0) | 0 (0) | 1 (1.2) | 0 (0) |