Table 4.
Adverse drug reactions during treatment with BPaLM/BPaL (n = 116).
| Events | BPaLM | BPaL |
|---|---|---|
| (n = 72) | (n = 44) | |
| n (%) | n (%) | |
| Haematologic events, i.e., anaemia (Hb < 10.5) | 23 (31.9) | 15 (34.0) |
| Severe anaemia (Hb < 8) | 0 | 0 |
| Anaemia requiring LZD dose or frequency adjustment | 0 | 1 (2.3) |
| Neurologic events | 5 (6.9) | 4 (9.1) |
| Peripheral neuropathy* | 4 (5.5) | 3 (6.8) |
| Optic neuropathy | 1 (1.4) | 1 (2.3) |
| Peripheral/optic neuropathy requiring LZD dose or frequency adjustment | 1 (1.4) | 1 (2.3) |
| Optic neuropathy requiring LZD discontinuation before treatment completion | 1 (2.3) | 0 |
| Elevated liver enzymes | 20 (27.7) | 10 (22.7) |
| Mild | 16 (22.2) | 7 (15.9) |
| Moderate | 2 (2.8) | 1 (2.3) |
| Severe | 2 (2.8) | 2 (4.5) |
| Drug-induced nephrotoxicity | 19 (26.3) | 10 (22.7) |
| Mild | 17 (23.6) | 9 (20.4) |
| Moderate | 2 (2.8) | 1 (2.2) |
| Prolonged QTcF interval | ||
| Mild | 40 (55.6) | 37 (84.1) |
| Moderate | 0 | 2 (4.5) |
| Other side effects not requiring a change in BPaLM/BPaL regimen | ||
| Gastrointestinal conditions | 26 (36.1) | 11 (25.0) |
| Rash or pruritic | 1 (3.8) | 1 (2.3) |
| Arthralgia | 11 (15.2) | 4 (9.1) |
*
Peripheral neuropathy is measured using a brief peripheral neuropathy screening tool.
BpaLM = bedaquiline, pretomanid, linezolid and moxifloxacin; BpaL = bedaquiline, pretomanid and linezolid; Hb = haemoglobin; LZD = linezolid.