Table 4.
Treatment Emergent Adverse Events for Various Regimens
| Regimen | PaMZ n=148 | BPaZ n=119 | BPaMZ n=60 | BPaL n=109 | HRZE n=120 |
|---|---|---|---|---|---|
| Trial | NIX-TB | ||||
| Nausea | 30 (20.3%) | 4 (3.4%) | 5 (8.3%) | 40 (36.7%) | 8 (6.7%) |
| Vomiting | 18 (12.2%) | 5 (4.2%) | 7 (11.7%) | 37 (33.9%) | 11 (9.2%) |
| Diarrhea | 10 (6.8%) | 4 (3.4%) | 3 (5%) | 11 (10.1%) | 3 (2.5%) |
| Abdominal pain/dyspepsia | 9 (6.1%) | 37 (34%) | 3 (2.5%) | ||
| Decreased appetite | 24 (22.0%) | ||||
| Abnormal weight loss | 11 (10.1%) | ||||
| Liver disorder | 33 (22.3%) | 9 (7.5%) | |||
| Enzyme abnormality | 7 (4.7%) | 4 (3.3%) | |||
| ALT increased | 8 (6.7%) | 2 (3.3%) | 10 (9.2%) | 2 (1.7%) | |
| AST increased | 6 (5%) | 3 (5%) | 9 (8.3%) | 3 (2.5%) | |
| Amylase increased | 10 (16.7%) | 1 (0.8%) | |||
| GGT increased | 2 (1.7%) | 6 (10%) | 19 (17.4%) | ||
| Anemia | 5 (4.2%) | 1 (1.7%) | 40 (36.7%) | ||
| Leukocytosis | 9 (6.1%) | 3 (2.5%) | |||
| Hyperkalemia or hyponatremia | 13 (8.8%) | 8 (6.7%) | |||
| Glucose abnormality | 9 (6.1%) - hyper | 12 (11%)-hypo | 3 (2.5%)- hyper | ||
| Hypoalbuminemia | 6 (4.1%) | 5 (4.2%) | |||
| Hyperuricemia | 42 (28.4%) | 28 (23.5%) | 27 (45%) | 26 (21.7%) | |
| Dizziness | 15 (10.1%) | 4 (3.4%) | 1 (1.7%) | 5 (4.2%) | |
| Headache | 14 (9.5%) | 30 (27.5%) | 2 (1.7%) | ||
| Peripheral sensory neuropathy* | 76 (69.7%) | ||||
| Myalgia | 7 (5.9%) | 3 (5%) | 1 (0.8%) | ||
| Arthralgia | 38 (25.7%) | 15 (12.6%) | 13 (21.7%) | 17 (14.2%) | |
| Extremity or back pain | 2 (1.7%) | 4 (6.7%) | 13 (11.9%) | ||
| Acne | 17 (15.6%) | ||||
| Rash | 3 (2.5%) | 1 (1.7%) | 17 (15.6%) | 2 (1.7%) | |
| Pruritus generalized | 8 (6.7%) | 2 (3.3%) | 8 (6.7%) | ||
| Pruritis | 8 (5.4%) | 5 (4.2%) | 2 (3.3%) | 16 (14.7%) | 8 (6.7%) |
| Hemoptysis | 4 (3.4%) | 6 (10%) | 14 (12.8%) | ||
| Pleuritic/non-cardiac chest pain | 6 (10%) | 14 (12.8%) | |||
| UTI | 2 (1.7%) | 4 (6.7%) | 2 (1.7%) |
Notes: *Peripheral sensory neuropathy includes related codes (eg, neuropathy peripheral, paresthesia, hypoesthesia, peripheral motor neuropathy, burning sensation, hyporeflexia, peripheral sensorimotor neuropathy).