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Table 3 Analysis of secondary MRI assessments at Week 48 (ITT population)

From: Lesion remyelinating activity of GSK239512 versus placebo in patients with relapsing-remitting multiple sclerosis: a randomised, single-blind, phase II study

  Patients, n Adjusted mean change from screening Difference in adjusted mean changea (90% CI) ESb (90% CI) Posterior probability
T2 lesion MTR at Week 48
 Placebo 57 0.002 −0.022 (−0.052, 0.009) −0.246 (−0.588, 0.095) 0.120
 GSK239512 50 -0.020
  Treatment n Mean rate Treatment comparison
Ratioc (90% CI)
 
Cumulative number of new and enlarging lesions at Week 48
 New GdE lesions Placebo 66 0.66 1.72 (1.05, 2.82)  
GSK239512 64 1.14   
 New and enlarging T2 lesions Placebo 66 1.45 1.18 (0.75, 1.85)  
GSK239512 64 1.71   
 Cumulative unique active lesions Placebo 66 1.48 1.17 (0.74, 1.85)  
GSK239512 64 1.74   
 New unenhanced T1 lesions Placebo 66 0.50 1.38 (0.87, 2.18)  
GSK239512 64 0.69   
Cumulative new GdE lesions evolving into chronic unenhancing T1 black holes Placebo 63 0.29 1.71 (1.05, 2.78)  
GSK239512 57 0.50   
  1. Data taken from the AES, all evaluable scans dataset
  2. CI confidence interval, ES effect size, GdE Gadolinium-enhanced, ITT intent-to-treat, MRI magnetic resonance imaging
  3. aAdjusted mean change for normalised MTR is the post-lesion MTR value change from average pre-lesion MTR value
  4. bES is defined as the treatment difference divided by the standard deviation of the treatment difference averaged across relative MRIs
  5. cTreatment Ratio (GSK239512/Placebo). A ratio <1 indicates a lower risk with GSK239512 versus placebo