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Table 3 Events in standard arm by treatment phase

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
  1. The number of grade 3 & 4 adverse events (total and related only) recorded in each treatment arm are shown with percentage of the total number of similar events across all treatment phases. Most common System Organ Classes for grade 3 & 4 adverse events are tabulated by treatment phase, along with tallies of patients in each phase split by the number of grade 3 or 4 adverse events experienced in the treatment phase. Serious adverse events in each phase are also shown, regardless of their severity grading. The denominator for each treatment phase was determined by subtracting the number of withdrawals and deaths from the denominator in the previous phase. The treatment phases were not independent and the same patient could appear in all three of the phases. *Note that some events excluded because of undocumented onset date