Change In Overall Vas Score From Baseline To Week 12; Responder Rates - Abbott Proclaim 3660 Clinician Manual

Table 33. Change in overall VAS score from baseline to week 12
Randomization
Stimulation
VAS at Baseline
Mean ± SD (N)
Minimum, Maximum
VAS at Week 12
Mean ± SD (N)
Minimum, Maximum
Burst-Tonic
Mean ± SD (N)
Minimum, Maximum
Burst-Tonic
95% UCB on Difference (Burst-Tonic)
Non-Inferiority Margin
p
-value for Non-Inferiority Test
p
-value for Superiority Test
The following table shows a cross-tabulation of responder rates (≥50% decrease in overall VAS
score from baseline) with burst and tonic stimulation. A total of 49 subjects (49%) responded to
tonic stimulation, burst stimulation, or both. The overall VAS scores decreased by at least 50% for
more subjects with burst stimulation than with tonic stimulation (17 versus 10).
Table 34. Responder rates (decrease of ≥50% from baseline) for overall daily VAS score
Overall Responder Rate
Burst subjects (n/N)
Tonic subjects (n/N)
Difference in responder rate with 95% CI*
(Burst-Tonic)
Cross-Tabulation of Responders by Stimulation Mode
Stimulation mode
Burst
* 95% CI was calculated using asymptotic method without continuity correction (May and
Johnson, 1997; Newcombe, 1998)
** Responder is defined as a subject whose overall VAS score decreased 50% or more from
baseline.
Responder**
No
Yes
57
Arm 1: tonic/burst
Tonic
72.7±11.4 (45)
44.4, 90.3
46.3±22.8 (45)
1.0, 88.1
-26.4±24.9 (45)
87.4, 34.0
-5.8±25.9
2.9
7.5
0.006
0.136
39/100 (39.0%)
32/100 (32.0%)
7.0% (-1.0%, 19.0%)
Tonic
No
51/100 (51.0%)
17/100 (17.0%)
Arm 2: burst/tonic
Burst
76.3±11.3 (55)
43.9, 98.9
44.2±25.3 (55)
0.0, 98.1
-32.1±26.7 (55)
87.7, 15.0
Yes
10/100 (10.0%)
22/100 (22.0%)