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Table 2 Statistical analysis of endpoints

From: Fingolimod after a first unilateral episode of acute optic neuritis (MOVING) – preliminary results from a randomized, rater-blind, active-controlled, phase 2 trial

 

Time

Relative Effect, Fingolimod

N

Relative Effect, IFN-β 1b

N

P-value

Treatment Arm

P-value

Time

P-value

Interaction

mfVEP Latency

Baseline

0.6889 (0.4692; 0.8060)

5

0.2917 (0.2029; 0.4268)

4

0.630

0.905

0.001

6 months

0.3778 (0.2134; 0.6298)

5

0.6250 (0.3622; 0.8020)

4

T2 Lesion Count

Baseline

0.4500 (0.2635; 0.6684)

5

0.5139 (0.2871; 0.7316)

4

0.935

0.239

0.164

6 months

0.5333 (0.3257; 0.7209)

5

0.5069 (0.2423; 0.7653)

4

T2 Lesion Volume

Baseline

0.5056 (0.3180; 0.6902)

5

0.4167 (0.2184; 0.6738)

4

0.696

<  0.001

0.876

6 months

0.5722 (0.3642; 0.7400)

5

0.4861 (0.2654; 0.7161)

4

mfVEP Latency

Baseline

0.6736 (0.3338; 0.8699)

3

0.2569 (0.1119; 0.5675)

3

0.400

0.773

0.004

3 months

0.2778 (0.1084; 0.6384)

3

0.7292 (0.5522; 0.8409)

3

6 months

0.4514 (0.1781; 0.7694)

3

0.6528 (0.2843; 0.8734)

3

12 months

0.3125 (0.1371; 0.6153)

3

0.6458 (0.4587; 0.7875)

3

  1. Statistical evaluation of the primary endpoint, mfVEP at 6 months compared to baseline, and of secondary endpoints (T2 lesion count and volume on brain MRI at 6 months vs. baseline; mfVEP latency at 3, 6 and 12 months vs. baseline). Estimation of relative effect size and unadjusted p values using non-parametric ANOVA-type statistics. Values in parentheses represent 95% confidence intervals. Only complete cases are included