Table 2.
Patients experienced adverse events, by approach.
| Overall N = 158 |
oSTR N = 80 |
aSTR N = 78 |
p-value | |
|---|---|---|---|---|
| Any TB drug-related grade 3–4 AE | 34 (21.5%) | 26 (32.5%) | 8 (10.3%) | <0.001 |
| Number of grade 3–4 AE per patient | <0.001 | |||
| 0 | 124 (78.5%) | 54 (67.5%) | 70 (89.7%) | |
| 1 | 26 (16.5%) | 20 (25.0%) | 6 (7.7%) | |
| 2 | 7 (4.4%) | 6 (7.5%) | 1 (1.3%) | |
| 3 | 1 (0.6%) | 0 (0.0%) | 1 (1.3%) | |
| Number of any grade AE per patient | 0.20 | |||
| 0 | 18 (11.4%) | 6 (7.5%) | 12 (15.4%) | |
| 1 | 35 (22.2%) | 17 (21.2%) | 18 (23.1%) | |
| 2 | 42 (26.6%) | 19 (23.8%) | 23 (29.5%) | |
| 3 | 35 (22.2%) | 20 (25.0%) | 15 (19.2%) | |
| 4 | 20 (12.7%) | 12 (15.0%) | 8 (10.3%) | |
| 5 | 7 (4.4%) | 6 (7.5%) | 1 (1.3%) | |
| 7 | 1 (0.6%) | 0 (0.0%) | 1 (1.3%) | |
| Neurotoxicity | <0.001 | |||
| None | 108 (68.4%) | 43 (53.8%) | 65 (83.3%) | |
| Grade 1–2 | 39 (24.7%) | 28 (35.0%) | 11 (14.1%) | |
| Grade 3–4A | 11 (7.0%) | 9 (11.2%) | 2 (2.6%) | |
| Anaemia | 0.002 | |||
| None | 101 (63.9%) | 41 (51.2%) | 60 (76.9%) | |
| Grade 1–2 | 42 (26.6%) | 27 (33.8%) | 15 (19.2%) | |
| Grade 3–4B | 15 (9.5%) | 12 (15.0%) | 3 (3.8%) | |
| Arthralgia | 0.002 | |||
| None | 141 (89.2%) | 65 (81.2%) | 76 (97.4%) | |
| Grade 1–2 | 16 (10.1%) | 14 (17.5%) | 2 (2.6%) | |
| Grade 3–4 | 1 (0.6%) | 1 (1.3%) | 0 (0.0%) | |
| Ototoxicity | 0.006 | |||
| None | 151 (95.6%) | 80 (100.0%) | 71 (91.0%) | |
| Grade 1–2 | 7 (4.4%) | 0 (0.0%) | 7 (9.0%) | |
| Nephrotoxicity | 0.04 | |||
| None | 140 (88.6%) | 75 (93.8%) | 65 (83.3%) | |
| Grade 1–2 | 18 (11.4%) | 5 (6.2%) | 13 (16.7%) | |
| Hepatotoxicity | 0.07 | |||
| None | 94 (59.5%) | 54 (67.5%) | 40 (51.3%) | |
| Grade 1–2 | 57 (36.1%) | 22 (27.5%) | 35 (44.9%) | |
| Grade 3–4C | 7 (4.4%) | 4 (5.0%) | 3 (3.8%) | |
| Nausea/vomiting | 0.86 | |||
| None | 53 (33.5%) | 26 (32.5%) | 27 (34.6%) | |
| Grade 1–2 | 97 (61.4%) | 49 (61.3%) | 48 (61.5%) | |
| Grade 3–4 | 8 (5.1%) | 5 (6.2%) | 3 (3.8%) | |
| QTC prolongation | 0.99 | |||
| None | 155 (98.1%) | 78 (97.5%) | 77 (98.7%) | |
| Grade 1–2 | 2 (1.3%) | 1 (1.3%) | 1 (1.3%) | |
| Grade 3–4 | 1 (0.6%) | 1 (1.3%) | 0 (0.0%) | |
| Others AED | 0.30 | |||
| None | 133 (84.2%) | 65 (81.3%) | 68 (87.2%) | |
| Grade 1–2 | 25 (15.8%) | 15 (18.8%) | 10 (12.8%) |
Two patients who experienced grade 3-4 neurotoxicity in the aSTR were under linezolid (1 from the start of treatment and 1 after switching amikacin to linezolid).
All 3 patients who experienced grade 3-4 anaemia in the aSTR were under linezolid from the start of treatment.
The 3 patients who experienced grade 3-4 hepatotoxicity in the aSTR were under linezolid from the start of treatment.
Others registered AE were gastritis disorders (19), skin rash/Pruritus (3), and ionic disturbances (3).
AE = adverse event; N = number; aSTR = Niger treatment strategy with a second-line injectable drug (SLID)-containing short treatment regimen (STR), with linezolid replacing the SLID in case of any grade of ototoxicity on monthly audiometry; oSTR = all oral short treatment regimen with linezolid throughout the intensive phase.