From: Toxicity associated with tuberculosis chemotherapy in the REMoxTB study
Intensive phase (Month 0–2) n = 639 | Continuation phase (Month 3–6) n = 596 | Follow Up phase (Month 7–18) n = 569 | |
---|---|---|---|
Total Grade 3 & 4 AEs Reported | 135 | 62 | 53 |
Related | 80 | 29 | 4 |
(% Total) | (59.3%) | (46.8%) | (7.5%) |
No of Grade 3 AEs Reported | 100 | 48 | 33 |
Related | 50 | 23 | 3 |
(%Grade3) | (50.0%) | (57.5%) | (9.1%) |
No. Grade 4 AEs Reported | 35 | 14 | 20 |
Related | 30 | 6 | 1 |
(%Grade4) | (85.7%) | (42.9%) | (5.0%) |
System Organ Class of Related Events* | |||
Hepatobiliary | 25 | 13 | 0 |
Musculoskeletal | 15 | 7 | 0 |
Metabolism & Nutrition | 9 | 1 | 2 |
Blood & Lymphatic | 5 | 2 | 1 |
No of Related Grade 3 or 4 AEs per Patient | |||
0 | 592 | 581 | 566 |
1 | 33 | 12 | 2 |
2 | 10 | 1 | 1 |
≥ 3 | 4 | 2 | 0 |
No of Patients with ≥ 1 SAE (% n) | 32 (5.0%) | 18 (3.0%) | 20 (3.5%) |
No of Patients with ≥ 1 Related SAE (%n) | 17 (2.7%) | 3 (0.5%) | 2 (0.4%) |
Mean No of SAEs per Patient | 1.78 | 1.39 | 1.60 |
No of Withdrawals | 38 | 26 | 1 |
No of Deaths | 5 | 1 | 10 |