Table 2.
Changes in clinical parameters at 12 months and 15 months using available data*
| All |
Early-phase dcSSc |
Late-phase dcSSc |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Δ 12 mos. | 95% CI | Δ 15 mos. | 95% CI | Δ 12 mos. | 95% CI | Δ 15 mos. | 95% CI | Δ 12 mos. | 95% CI | Δ 15 mos. | 95% CI | |
| MRSS | ||||||||||||
| Total CI | −3.4 ± 7.6 | −5.2 to −1.5 | −4.9 ± 7.1 | −6.9 to −2.8 | −1.5 ± 8.0 | −4.0 to −1.0 | −2.6 ± 7.5 | −5.6 to 0.4 | −6.4 ± 5.8 | −8.8 to −4.0 | −7.9 ± 53† | −10.4 to −5.4 |
| No. of patients | 66 | 47 | 41 | 27 | 25 | 20 | ||||||
| Total placebo | −2.4 ± 7.7 | −4.1 to −0.5 | −2.9 ± 6.8 | −4.6 to −1.1 | −1.1 ± 8.6 | −3.9 to 1.7 | −2.8 ± 7.3 | −5.4 to −.2 | −3.8 ± 6.3 | −6.0 to −1.5 | −2.9 ± 6.5 | −5.4 to −0.5 |
| No. of patients | 73 | 63 | 39 | 33 | 34 | 30 | ||||||
| SF-36 index component summary score |
||||||||||||
| Total CI | 0.02 ± 0.1‡ | 0 to 0.04 | −0.011 ± 0.12 | −0.05 to 0.03 | 0.01 ± 0.11 | −0.02 to 0.05 | −0.03 ± 0.13 | −0.08 to 0.02 | −0.03 ± 0.07‡ | 0.01 to 0.06 | 0.01 ± 0.11 | −0.04 to 0.03 |
| No. of patients | 64 | 49 | 40 | 29 | 24 | 20 | ||||||
| Total placebo | −0.01 ± 0.1 | −0.03 to 0.01 | −0.02 ± 0.11 | −0.05 to 0.01 | −0.02 ± 0.1 | −0.05 to 0.02 | −0.05 ± 0.12 | −0.09 to 0 | 0 ± 0.10 | −0.04 to 0.03 | 0.01 ± 0.10 | −0.03 to 0.04 |
| No. of patients | 71 | 62 | 39 | 33 | 34 | 29 | ||||||
| Weight, lbs | ||||||||||||
| Total CI | −3.0 ± 7.8‡ | −4.9 to 1.0 | −2.4 ± 9.7 | −5.2 to 0.4 | −2.6 ± 7.3 | −5.0 to −0.26 | −0.6 ± 7.2 | −3.4 to 2.1 | −3.5 ± 8.7 | −7.1 to 0.1 | −5.0 ± 12.2 | −10.7 to 0.8 |
| No. of patients | 64 | 49 | 39 | 29 | 25 | 20 | ||||||
| Total placebo | −0.2 ± 93 | −2.4 to 2.0 | 0.8 ± 10.4 | −1.9 to 3.4 | 0.9 ± 11.0 | −2.7 to 4.5 | 3.0 ± 12.2 | −13 to 7.4 | −1.4 ± 6.8 | −3.8 to 1.0 | −1.73 ± 7.4 | −4.5 to 1.0 |
| No. of patients | 71 | 63 | 38 | 33 | 33 | 30 | ||||||
| Diastolic BP, mm Hg | ||||||||||||
| Total CI | 0.92 ± 10.8 | −1.8 to 3.6 | −0.67 ± 11.4 | −4.0 to 2.6 | 0.73 ± 9.9 | −2.4 to 3.8 | −4.07 ± 8.8§ | −7.4 to 0.7 | 1.25 ± 12.4 | −4.0 to 6.5 | 4.53 ± 13.1 | −1.8 to 10.9 |
| No. of patients | 65 | 48 | 41 | 29 | 24 | 19 | ||||||
| Total placebo | 2.6 ± 13.9 | −0.7 to 5.9 | 5.4 ± 20.6 | 0.2 to 10.6 | 1.98 ± 10.3 | −1.3 to 5.3 | 6.79 ± 23.1 | −1.4 to 1.5 | 3.36 ± 17.5 | −2.9 to 9.6 | 3.93 ± 17.7 | −2.7 to 10.6 |
| No. of patients | 73 | 63 | 40 | 33 | 33 | 30 | ||||||
| Patient’s pain assessment VAS |
||||||||||||
| Total CI | −3.60 ± 24.4 | −9.6 to 2.4 | −4.8 ± 21.4 | −10.9 to 1.3 | −1.66 ± 24.5§ | −9.5 to 6.2 | −4.42 ± 18.4 | −113 to 2.5 | −6.69 ± 24.3 | −16.7 to 3.4 | −5.44 ± 25.7 | −17.5 to 6.6 |
| No. of patients | 65 | 50 | 40 | 30 | 25 | 20 | ||||||
| Total placebo | 8.89 ± 25.4 | −14.8 to −3.0 | −4.08 ± 25.2 | −10.4 to 2.3 | −13.3 ± 21.0 | −20.1 to −6.5 | −6.32 ± 24.5 | −15.0 to 2.4 | −3.82 ± 29.14 | −14.0 to 6.4 | −1.62 ± 26.2 | −11.4 to 8.2 |
| No. of patients | 73 | 63 | 39 | 33 | 34 | 30 | ||||||
*
Except where indicated otherwise, values are the mean ± SD. Only clinical parameters showing significant differences between the CI- and placebo-treated patients in ≥1 of the groups are shown. Clinical parameters showing no significant differences between the CI- and placebo-treated patients in any of the patient groups are listed online at http://www.utmem.edu/ctr/. 95% CI = 95% confidence interval (see Table 1 for other definitions).
†
P < 0.01 versus placebo, by rank sum test using available data.
‡
P < 0.05 versus placebo, by rank sum test using available data.
§
P < 0.02 versus placebo, by rank sum test using available data.