Table 4.
Comparison of monitoring characteristics between treatment groups*.
| L-carntine baseline (n) | L-carnitine end (n) | Total Δ (%) | Placebo baseline (n) | Placebo end (n) | Total Δ (%) | Contrast between groups (95% CI) | P-value for contrast between groups | |
|---|---|---|---|---|---|---|---|---|
| Total PRISE** (Parent) | 4.9±3.7*** (15) | 2.3±1.8 (15) | −2.7±4.0 (−53) | 6.9±4.6 (8) | 4.0±2.0 (8) | −2.9±3.2 (−42) | 0.2# (−3.2 to 3.6) | 0.90 |
| TAM (Parent) | – | 87.3±15.1 (15) | – | – | 93.1±8.8 (8) | – | −5.8 (−18 to 16.3) | 0.33 |
| FISER/GRSEB** | – | 0.73±2.8 (15) | – | – | 0.0±0.0 (8) | – | 0.73 (−0.69 to 2.1) | 0.33 |
*
CI – confidence interval; FISER/GRSEB – frequency and intensity of side effect rating/global rating of side effect burden; PRISE – patient report of incidence of side effects; TAM – treatment adherence measurement;
**
higher values are associated with worse clinically outcomes;
***
mean ±SD;
#
t-test statistic.