Table 6.
Adverse events in the safety analysis population
|
Patients with drug-susceptible tuberculosis |
Patients with rifampicin-resistant tuberculosis (BPaMZ group [n=60]) | |||||
|---|---|---|---|---|---|---|
| BloadPaZ group (n=59) | B200PaZ group (n=60) | HRZE group (n=61) | p value | |||
| ≥1 grade 3 treatment-emergent adverse event | 19 (32%) | 17 (28%) | 14 (23%) | 0·53 | 13 (22%) | |
| ≥1 grade 4 treatment-emergent adverse event | 8 (14%) | 7 (12%) | 2 (3%) | 0·11 | 1 (2%) | |
| ≥1 serious treatment-emergent adverse event | 4 (7%) | 3 (5%) | 4 (7%) | 0·93 | 4 (7%) | |
| ≥1 serious liver-related treatment-emergent adverse event | 2 (3%) | 0 | 2 (3%) | 0·47 | 2 (3%) | |
| ≥1 treatment-emergent adverse event leading to treatment discontinuation | 6 (10%) | 5 (8%) | 2 (3%) | 0·28 | 2 (3%) | |
| Deaths during treatment/total deaths (%) | 1/2 (50%) | 1/3 (33%) | 1/2 (50%) | 1·0*; 0·90† | 0/4 (0%) | |
| Liver toxicity | ||||||
| ALT or AST ≥5 × ULN | 6 (10%) | 4 (7%) | 3 (5%) | 0·48 | 3 (5%) | |
| ALT or AST ≥10 × ULN | 3 (5%) | 3 (5%) | 1 (2%) | 0·57 | 1 (2%) | |
| ECG findings | ||||||
| ≥60 ms increase in QTc interval from baseline | 0 | 3 (5%) | 1 (2%) | 0·07 | 0 | |
Data are n (%) unless otherwise stated. All patients who received at least dose of trial medication included in the analysis. ALT=alanine aminotransferase. AST=aspartate aminotransferase. BloadPaZ=bedaquiline (loading dose), pretomanid, and pyrazinamide. B200PaZ=bedaquiline (daily dose), pretomanid, and pyrazinamide. BPaMZ=bedaquiline (daily dose), pretomanid, and pyrazinamide plus moxifloxacin. ECG=electrocardiogram. HRZE=isoniazid, rifampicin, pyrazinamide, and ethambutol. ULN=upper limit of normal.
*
p value for deaths during treatment.
†
p value for total deaths.