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Table 1 Summary of the numbers of patients with significant elevations in liver enzyme concentration (≥3 × ULN, ≥5 × ULN and ≥10 × ULN) by treatment arm

From: Liver toxicity associated with tuberculosis chemotherapy in the REMoxTB study

  Standard arm
(2EHRZ/4HR)
Isoniazid arm
(2MHRZ/2MHR)
Ethambutol arm
(2EMRZ/2MR)
p value
n 1 634 649 634  
Median peak ALT as × ULN (IQR) 0.83
(0.56–1.35)
0.78
(0.53–1.23)
0.73
(0.51–1.09)
0.0465
0.0006
Median time to peak ALT in arm (days) 28
(14–84)
28
(14–84)
55
(14–84)
0.9725
0.0176
Median time to peak ALT (days) if ≥3 × ULN 28
(14–56)
18
(14–56)
28
(27–56)
0.7555
0.6056
Median time to ALT < 1 × ULN2
(days)
26
(15–42)
28
(19–42)
39
(30–61)
0.5605
0.2706
No with peak ALT ≥ 3 × ULN and < 5 × ULN (%n3) 21
(3.3%)
17
(2.6%)
11
(1.7%)
0.2047
 Bilirubin > 2 × ULN 2
(0.3%)
4
(0.6%)
0
(0.0%)
0.1427
 INR4 >1.5 0
(0.0%)
3
(0.5%)
1
(0.2%)
0.0987
No with peak ALT ≥ 5 × ULN and < 10 × ULN (%n3) 13
(2.0%)
16
(2.4%)
11
(1.7%)
0.6567
 Bilirubin > 2 × ULN 1
(0.2%)
2
(0.3%)
1
(0.2%)
0.7927
 INR4 >1.5 0
(0.0%)
0
(0.0%)
0
(0.0%)
 
No with peak ALT ≥10 × ULN (%n3) 7
(1.1%)
2
(0.3%)
3
(0.5%)
0.1647
 Bilirubin > 2 × ULN 2
(0.3%)
0
(0.0%)
1
(0.2%)
0.3607
 INR4 >1.5 0
(0.0%)
0
(0.0%)
0
(0.0%)
 
No of liver-related withdrawals 11
(1.7%)
7
(1.1%)
4
(0.6%)
0.178
  1. Median days from the start of treatment to reach individual patient peak concentrations and the number of patients withdrawing from treatment for liver-related reasons are reported
  2. ALT alanine aminotransferase, INR international normalised ratio, IQR interquartile range, ULN upper limit of normal
  3. 1 Some patients not included due to missing ALT results
  4. 2 If peak value ≥3 × ULN
  5. 3%n refers to percentage of total patients in the treatment arm
  6. 4 Patients with known anti-coagulant use were excluded from INR numbers
  7. 5 Isoniazid arm against standard therapy
  8. 6 Ethambutol arm against standard therapy
  9. 7 Chi-squared test (Fisher’s exact if any n ≤ 5)