From: Toxicity associated with tuberculosis chemotherapy in the REMoxTB study
Standard Arm (2EHRZ/4HR) n = 639 | Isoniazid Arm (2MHRZ/2MHR) n = 655 | Ethambutol Arm (2EMRZ/2MR) n = 636 | P value | ||
---|---|---|---|---|---|
Intensive Phase (Weeks 0–8) | Patients with ≥ 1 Grade 3/4 AEs (Tot No AEs) | 85 (135) | 83 (119) | 66 (114) | 0.24 |
Patients with ≥ 1 Related Grade 3/4 AEs (Tot No AEs) | 47 (80) | 36 (51) | 25 (44) | 0.03 | |
Continuation Phase (Weeks 9–17) | Patients with ≥ 1 Grade 3/4 AEs (Tot No AEs) | 29 (47) | 25 (32) | 26 (37) | 0.81 |
Patients with ≥ 1 Related Grade 3/4 AEs (Tot No AEs) | 14 (27) | 9 (9) | 16 (19) | 0.32 | |
Continuation/Placebo Phase (Weeks 18–26) | Patients with ≥ 1 Grade 3/4 AEs (Tot No AEs) | 12 (15) | 13 (17) | 17 (21) | 0.57 |
Patients with ≥ 1 Related Grade 3/4 AEs (Tot No AEs) | 2 (2) | 3 (3) | 2 (2) | 0.88 | |
Total* | Patients with ≥ 1 Grade 3/4 AEs (≥1 Related Grade 3/4 AEs) | 128 (57) | 103 (45) | 94 (40) | 0.40 (0.21) |
Total Grade 3/4 AEs (Related Grade 3/4 AEs only) | 250 (113) | 217 (64) | 209 (66) |