| 1 % Change in cramp frequency from baseline at 4 weeks |
2 |
83 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.93 [‐21.12, 13.26] |
| 2 % Change in cramp frequency from baseline at 12 weeks |
1 |
43 |
Mean Difference (IV, Fixed, 95% CI) |
‐12.09 [‐40.22, 16.04] |
| 3 Proportion of subjects with a ≥ 25% reduction in cramp frequency at 4 weeks |
2 |
83 |
Risk Difference (M‐H, Fixed, 95% CI) |
‐0.08 [‐0.28, 0.12] |
| 4 Proportion of subjects with a ≥ 25% reduction in cramps at 12 weeks |
1 |
43 |
Risk Difference (M‐H, Fixed, 95% CI) |
0.11 [‐0.19, 0.41] |
| 5 Number of cramps per week at 4 weeks |
4 |
213 |
Mean Difference (Fixed, 95% CI) |
0.01 [‐0.52, 0.55] |
| 6 Number of cramps per week at 12 weeks |
1 |
43 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.84 [‐3.23, 1.55] |
| 7 Cramp intensity (pain) on a 3 point scale (1 = mild, 2 = moderate, 3 = severe) at 4 weeks |
3 |
175 |
Mean Difference (Fixed, 95% CI) |
‐0.04 [‐0.18, 0.11] |
| 8 Cramp intensity (pain) on a 3 point scale (1 = mild, 2 = moderate, 3 = severe) at 12 weeks |
1 |
43 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.18 [‐0.55, 0.19] |
| 9 Proportion of subjects rating their cramps as moderate or severe (i.e. ≥ 2 on the 3 point intensity scale) at 4 weeks |
2 |
91 |
Risk Difference (M‐H, Fixed, 95% CI) |
0.09 [‐0.07, 0.25] |
| 10 Proportion of subjects rating their cramps as moderate to severe (i.e. with mean cramp intensity ≥2 on the 3 point intensity scale) at 12 weeks |
1 |
43 |
Risk Difference (M‐H, Fixed, 95% CI) |
‐0.06 [‐0.21, 0.10] |
| 11 Proportion of subjects with the majority of cramp durations ≥ 1 minute at 4 weeks |
1 |
46 |
Risk Difference (M‐H, Fixed, 95% CI) |
0.19 [‐0.07, 0.45] |
| 12 Proportion of subjects with majority of cramp durations ≥ 1 minute at 12 weeks |
1 |
43 |
Risk Difference (M‐H, Fixed, 95% CI) |
0.14 [‐0.13, 0.42] |
