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Table 5 Comparing adverse events in treatment arms

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)  
  1. The number of patients experiencing one or more grade 3 or 4 adverse event, and those who experienced events considered related to treatment only, are shown according to the treatment phase and study arm in the trial. The numbers of events are shown in brackets. The Chi square test was used to test for significant differences between the treatment arms for the proportions of patients who experienced ≥1 event in each treatment phase, for both total and related-only grade 3 or 4 AEs. Number of patients shown is number for that treatment window: 4 patients with ≥1 related AE appear in more than one time window on standard therapy, and 3 patients in both the isoniazid and ethambutol arms. Additionally, two patients excluded from the total count on the standard arm as no start date for AEs recorded *AEs that occurred in the follow-up phase (months 7–18) included in total