Table 2.
Specific neuropathic signs and symptoms and neuropathy status [number (% of nonmissing observations)]
| Baseline |
Week 24 |
Week 48 |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo n = 28 |
VCV n = 90 |
Placebo n = 28 |
VCV n = 90 |
Difference (95% CI)* |
Difference (95% CI)† |
Placebo n = 28 |
VCV n = 90 |
Difference (95% CI)* |
Difference (95% CI)† |
|
| Loss of vibration | 14 (54%)a | 34 (40%)a | 10 (50%)d | 31 (43%)d | 7% (−17%, 31%) | 10% (−12%, 29%) | 13 (57%)i | 32 (46%)i | 11% (−13%, 33%) | 7% (−15%, 26%) |
| Absence of reflexes | 17 (65%)b | 46 (53%)b | 11 (55%)e | 37 (52%)e | 3% (−22%, 26%) | 6% (−15%, 24%) | 12 (57%)j | 34 (49%)j | 8% (−17%, 31%) | 7% (−15%, 25%) |
| Pain | 7 (25%) | 28 (31%) | 6 (29%)f | 23 (29%)f | –1% (−20%, 23%) | 8% (−13%, 28%) | 3 (13%)k | 21 (28%)k | –15% (−30%, 7%) | –11% (−29%, 10%) |
| Pins & needles | 6 (21%) | 21 (23%) | 5 (24%)f | 18 (23%)f | 1% (−17%, 24%) | 10% (−10%, 30%) | 4 (17%)k | 21 (28%)k | –11% (−27%, 12%) | –8% (−26%, 15%) |
| Numbness | 10 (36%) | 33 (37%) | 7 (33%)f | 27 (35%)f | –1% (−22%, 23%) | 7% (−14%, 27%) | 5 (22%)k | 25 (33%)k | –12% (−29%, 12%) | –9% (−28%, 14%) |
| Symptomatic | 12 (43%) | 42 (47%) | 9 (43%)f | 30 (38%)f | 4% (−18%, 28%) | 10% (−11%, 30%) | 7 (30%)k | 31 (41%)k | –11% (−31%, 13%) | –8% (−29%, 14%) |
| Neuropathy (PN) | 18 (69%)b | 54 (62%)b | 12 (60%)g | 44(63%)g | –3% (−27%, 19%) | 0.3% (−21%, 18%) | 15 (65%)i | 45 (64%)i | 1% (−22%, 22%) | –1% (−22%, 16%) |
| Symptomatic neuropathy (SPN) | 9 (35%)c | 35 (40%)c | 6 (30%)h | 24(32%)h | –2% (−22%, 22%) | 7% (−14%, 27%) | 7 (30%)l | 25 (34%)l | –4% (−23%, 19%) | –4% (−24%, 18%) |
| Painful neuropathy (PPN) | 5 (18%) | 23 (26%) | 5(24%)f | 19 (24%)f | –1% (−18%, 23%) | 8% (−11%, 29%) | 3 (13%)k | 18 (24%)k | –11% (−25%, 10%) | –8% (−26%, 14%) |
Note: VCV = vicriviroc.
*
Estimates and 95% exact confidence intervals of the differences, based on “observed data” approach, in the proportions between groups (placebo – VCV).
†
Estimates and 95% exact confidence intervals of the differences, based on “ITT” approach, in the proportions between groups (placebo – VCV).
a
Missing 2/4 in placebo/VCV.
b
Missing 2/3 in placebo/VCV.
c
Missing 2/2 in placebo/VCV.
d
Missing 8/18 in placebo/VCV.
e
Missing 8/19 in placebo/VCV.
f
Missing 7/12 in placebo/VCV.
g
Missing 8/20 in placebo/VCV.
h
Missing 8/15 in placebo/VCV.
i
Missing 5/20 in placebo/VCV.
j
Missing 7/21 in placebo/VCV.
k
Missing 5/15 in placebo/VCV.
l
Missing 5/17 in placebo/VCV.