Table 2 Analysis of primary outcome and prespecified subgroups in the CC- and CT-genotype intention-to-treat population

From: Genotype-stratified adjunctive dexamethasone for tuberculous meningitis in HIV-negative adults: a randomized controlled phase 3 trial

 

Dexamethasone (n = 305)

Placebo (n = 308)

Comparison

Test for heterogeneitya

events/n (risk (%))

events/n (risk (%))

Hazard ratio (95% CI)

P value

LTA4H genotype

–

–

–

0.32

CC

50/146 (34.2)

56/145 (38.6)

0.83 (0.57–1.22)

–

CT

58/159 (36.5)

54/163 (33.1)

1.09 (0.76–1.59)

–

TBM diagnosis

–

–

–

0.58

Definite

49/128 (38.3)

57/139 (41.0)

0.87 (0.59–1.28)

–

Probable

43/107 (40.2)

37/108 (34.3)

1.18 (0.76–1.83)

–

Possible

16/70 (22.9)

16/61 (26.2)

0.88 (0.44–1.75)

–

Modified MRC severity grade

–

–

–

0.75

Grade I

21/134 (15.7)

24/132 (18.2)

0.86 (0.48–1.54)

–

Grade II

70/150 (46.7)

69/151 (46.0)

0.97 (0.70–1.35)

–

Grade III

17/21 (81.0)

17/25 (68.0)

1.17 (0.60–2.30)

–

Antituberculosis drug resistance~

–

–

–

0.48

Multidrug resistant or rifampicin mono-resistant

2/5 (40.0)

1/3 (33.3)

0.99 (0.09–11.01)

–

Isoniazid resistant without rifampicin resistance

6/18 (33.3)

10/16 (62.5)

0.46 (0.17–1.28)

–

No or other resistance

25/53 (47.2)

25/54 (46.3)

0.93 (0.53–1.62)

–

M. tuberculosis not isolated or missing result

74/228 (32.5)

74/235 (31.5)

1.02 (0.74–1.40)

–

  1. aHeterogeneity was tested by a likelihood ratio test between two Cox models fitted on the full population, one with an interaction term between treatment arm and the subgroup covariable and one without. No correction for multiplicity is made. The primary endpoint was death from any cause or new neurological event over the first 12 months after randomization. This table reports the results from the Cox proportional hazards regression model. Hazard ratios and the CIs were estimated by a univariate Cox’s proportional hazard model in each subgroup. The primary effect measure was the resulting hazard ratio comparing dexamethasone versus placebo with a corresponding two-sided 95% CI. The proportional-hazards assumption was tested for each model and was not violated (P > 0.05). In subgroup analyses, a separate Cox model was fit for each value of the subgroup. The test for heterogeneity was based on the likelihood ratio test that includes subgroup as covariate and compares the models with subgroup as main effect only and with subgroup as treatment effect modifier.
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