| 1 Overall cervical dystonia improvement as assessed with TWSTRS: change from baseline to week 4 |
3 |
|
Mean Difference (Fixed, 95% CI) |
6.78 [4.54, 9.01] |
| 2 Overall cervical dystonia improvement as assessed with TWSTRS: change from baseline to week 4 ‐ Doses subgroup analysis |
4 |
|
Mean Difference (Fixed, 95% CI) |
Subtotals only |
| 2.1 2500 units |
2 |
|
Mean Difference (Fixed, 95% CI) |
6.95 [3.70, 10.21] |
| 2.2 5000 units |
3 |
|
Mean Difference (Fixed, 95% CI) |
6.10 [3.40, 8.81] |
| 2.3 10,000 units |
4 |
|
Mean Difference (Fixed, 95% CI) |
8.72 [6.35, 11.10] |
| 3 Overall cervical dystonia improvement as assessed with TWSTRS: change from baseline to week 4 ‐ BtA‐responsive vs BtA‐non‐responsive subgroup analysis |
2 |
|
Mean Difference (Fixed, 95% CI) |
7.56 [4.41, 10.71] |
| 3.1 BtA‐responsive |
1 |
|
Mean Difference (Fixed, 95% CI) |
9.0 [4.46, 13.54] |
| 3.2 BtA‐non‐responsive |
1 |
|
Mean Difference (Fixed, 95% CI) |
6.22 [1.83, 10.60] |
| 4 Proportion of participants with adverse events |
2 |
186 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.09 [0.97, 1.23] |
| 5 Proportion of participants with adverse events ‐ doses subgroup analysis |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 5.1 5000 U |
1 |
72 |
Risk Ratio (M‐H, Random, 95% CI) |
1.07 [0.89, 1.29] |
| 5.2 10,000 U |
2 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
1.09 [0.89, 1.33] |
| 6 Proportion of participants with adverse events ‐ BtA‐responsive vs BtA‐non‐responsive subgroup analysis |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 6.1 BtA‐responsive |
1 |
73 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.79, 1.20] |
| 6.2 BtA‐non‐responsive |
1 |
77 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [1.03, 1.37] |
| 7 Subjective change as assessed by the participant at week 4 |
3 |
316 |
Std. Mean Difference (IV, Fixed, 95% CI) |
0.86 [0.61, 1.10] |
| 8 Subjective change as assessed by the clinician at week 4 |
3 |
316 |
Std. Mean Difference (IV, Fixed, 95% CI) |
0.80 [0.55, 1.04] |
| 9 Subjective change as assessed by the participant at week 4 ‐ doses subgroup analysis |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 9.1 2500 U |
1 |
67 |
Mean Difference (IV, Fixed, 95% CI) |
12.30 [4.21, 20.39] |
| 9.2 5000 U |
2 |
137 |
Mean Difference (IV, Fixed, 95% CI) |
9.71 [4.05, 15.37] |
| 9.3 10,000 U |
3 |
214 |
Mean Difference (IV, Fixed, 95% CI) |
15.12 [10.32, 19.91] |
| 10 Subjective change as assessed by the clinician at week 4 ‐ doses subgroup analysis |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 10.1 2500 U |
1 |
67 |
Mean Difference (IV, Fixed, 95% CI) |
8.60 [1.46, 15.74] |
| 10.2 5000 U |
2 |
137 |
Mean Difference (IV, Fixed, 95% CI) |
10.84 [5.65, 16.04] |
| 10.3 10,000 U |
3 |
214 |
Mean Difference (IV, Fixed, 95% CI) |
13.22 [9.39, 17.05] |
| 11 Subjective change as assessed by the participant at week 4 ‐ BtA‐responsive vs BtA‐non‐responsive subgroup analysis |
2 |
186 |
Mean Difference (IV, Fixed, 95% CI) |
19.83 [13.61, 26.05] |
| 11.1 BtA‐responsive |
1 |
109 |
Mean Difference (IV, Fixed, 95% CI) |
19.03 [10.41, 27.65] |
| 11.2 BtA‐non‐responsive |
1 |
77 |
Mean Difference (IV, Fixed, 95% CI) |
20.70 [11.73, 29.67] |
| 12 Subjective change as assessed by the clinician at week 4 ‐ BtA‐non‐responsive vs ‐responsive subgroup analysis |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 12.1 BtA‐responsive |
1 |
109 |
Mean Difference (IV, Fixed, 95% CI) |
12.74 [5.83, 19.65] |
| 12.2 BtA‐non‐responsive |
1 |
77 |
Mean Difference (IV, Fixed, 95% CI) |
12.70 [7.04, 18.36] |
| 13 Cervical dystonia associated pain: change from baseline to week 4 as assessed with TWSTRS |
2 |
|
Mean Difference (Fixed, 95% CI) |
2.20 [1.25, 3.15] |
| 14 Cervical dystonia associated pain: change from baseline to week 4 as assessed with TWSTRS ‐ doses subgroup analysis |
3 |
|
Mean Difference (Fixed, 95% CI) |
Subtotals only |
| 14.1 2500 units |
2 |
|
Mean Difference (Fixed, 95% CI) |
2.58 [1.33, 3.84] |
| 14.2 5000 units |
2 |
|
Mean Difference (Fixed, 95% CI) |
2.05 [0.83, 3.27] |
| 14.3 10,000 units |
3 |
|
Mean Difference (Fixed, 95% CI) |
3.07 [1.99, 4.14] |
| 15 Cervical dystonia associated pain: change from baseline to week 4 as assessed with validated scales ‐ BtA‐responsive vs BtA‐non‐responsive subgroup analysis |
2 |
|
Std. Mean Difference (Fixed, 95% CI) |
0.96 [0.65, 1.27] |
| 15.1 BtA‐responsive |
1 |
|
Std. Mean Difference (Fixed, 95% CI) |
0.92 [0.50, 1.34] |
| 15.2 BtA‐non‐responsive |
1 |
|
Std. Mean Difference (Fixed, 95% CI) |
1.01 [0.53, 1.48] |
| 16 Cervical dystonia severity: change from baseline to week 4 as assessed with TWSTRS |
2 |
|
Mean Difference (Fixed, 95% CI) |
2.43 [1.24, 3.63] |
| 17 Cervical dystonia severity: change from baseline to week 4 as assessed with TWSTRS ‐ doses subgroup analysis |
3 |
|
Mean Difference (Fixed, 95% CI) |
Subtotals only |
| 17.1 2500 units |
2 |
|
Mean Difference (Fixed, 95% CI) |
1.9 [0.55, 3.25] |
| 17.2 5000 units |
2 |
|
Mean Difference (Fixed, 95% CI) |
2.51 [1.25, 3.77] |
| 17.3 10,000 units |
3 |
|
Mean Difference (Fixed, 95% CI) |
2.96 [1.87, 4.05] |
| 18 Cervical dystonia associated disability: change from baseline to week 4 as assessed with TWSTRS |
2 |
|
Mean Difference (Fixed, 95% CI) |
2.29 [1.04, 3.54] |
| 19 Cervical dystonia associated disability: change from baseline to week 4 as assessed with TWSTRS ‐ doses subgroup analysis |
3 |
|
Mean Difference (Fixed, 95% CI) |
Subtotals only |
| 19.1 2500 units |
2 |
|
Mean Difference (Fixed, 95% CI) |
2.32 [0.86, 3.78] |
| 19.2 5000 units |
2 |
|
Mean Difference (Fixed, 95% CI) |
2.06 [0.55, 3.57] |
| 19.3 10,000 units |
3 |
|
Mean Difference (Fixed, 95% CI) |
3.22 [2.09, 4.35] |
| 20 Proportion of withdrawals due to adverse events |
4 |
440 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.19, 4.06] |
| 21 Adverse events: dry mouth |
4 |
438 |
Risk Ratio (M‐H, Fixed, 95% CI) |
7.65 [2.75, 21.32] |
| 22 Adverse events: dysphagia |
4 |
438 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.78 [2.42, 19.05] |
| 23 Adverse events: dry mouth ‐ doses subgroup analysis |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 23.1 2500 U |
2 |
128 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.06, 14.78] |
| 23.2 5000 U |
3 |
198 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.94 [0.87, 17.86] |
| 23.3 10,000 U |
4 |
274 |
Risk Ratio (M‐H, Fixed, 95% CI) |
11.47 [3.95, 33.30] |
| 24 Adverse events: dysphagia ‐ doses subgroup analysis |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 24.1 2500 U |
2 |
128 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.79 [0.86, 53.63] |
| 24.2 5000 U |
3 |
198 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.50 [1.25, 24.17] |
| 24.3 10,000 U |
4 |
274 |
Risk Ratio (M‐H, Fixed, 95% CI) |
9.19 [3.38, 25.01] |
| 25 Adverse events: infection |
3 |
308 |
Risk Ratio (M‐H, Random, 95% CI) |
1.14 [0.38, 3.38] |
| 26 Adverse events: neck pain secondary to CD |
3 |
308 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.08 [0.67, 1.73] |
| 27 Adverse events: injection site pain |
4 |
438 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.39 [0.73, 2.66] |
| 28 Adverse events: nausea |
2 |
199 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.06 [0.68, 6.28] |
| 29 Adverse events: headache |
3 |
361 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.90 [0.82, 4.41] |
| 30 Adverse events: flu syndrome |
3 |
361 |
Risk Ratio (M‐H, Random, 95% CI) |
1.44 [0.23, 8.92] |
| 31 Adverse events: pain |
2 |
231 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.15 [0.51, 2.62] |
