| Period (analysis set) | ||
---|---|---|---|
 | IVIg restabilization (PSDS) | SC treatment (ITTS, PPS) | IVIg rescue (RSDS) |
INCAT | |||
Total | Overall: - Descriptive statistics - Change from reference visit - Time to first improvement on IgPro10: Kaplan-Meier estimates | - By treatment and by treatment and subgroup: - Descriptive statistics - Comparison between treatments of changes from reference visit: exact Jonckheere-Terpstra testa - Comparisons between each IgPro20 dose group and placebo group, and the comparison between the two IgPro20 dose groups of changes from reference visit: Wilcoxon rank sum testb - Time to CIDP relapse or withdrawal for any other reason: Kaplan-Meier estimatesc | Overall: - Descriptive statistics - Change from reference visit - Time to improvement after CIDP relapse with IgPro10 rescue: Kaplan-Meier estimates |
Mean grip strength (Dominant/non-dominant hand), MRC sum score, I-RODS | |||
 | Overall: - Descriptive statistics - Change from reference visit - Time to first improvement on IgPro10: Kaplan-Meier estimates | By treatment and by treatment and subgroup: - Descriptive statistics - Comparison between treatments of changes from reference visit; exact Jonckheere-Terpstra testa - Comparisons between each IgPro20 dose group and placebo group, and the comparison between the two IgPro20 dose groups of changes from reference visit; Wilcoxon rank sum testb | Overall: - Descriptive statistics - Change from reference visit |
Electrophysiological parameters (average distal latency, average proximal latency, overall average conduction velocity, average conduction block, and average compound muscle action potential amplitude) | |||
 |  | By treatment and by treatment and subgroup: - Descriptive statistics - Change from reference visit - Between-treatment comparisons of the changes from baseline: analysis of variance (ANOVA) modeld |  |
IgG level | |||
 | Overall: - Descriptive statistics - Change from reference visit | By treatment and by treatment and subgroup: - Descriptive statistics - Change from reference visit | Overall: - Descriptive statistics - Change from reference visit |
EQ-5D dimensions, TSQM, WPAI-GH | |||
 | Overall: - Descriptive statistics | By treatment: - Descriptive statistics - Change from reference visit - Comparison between treatments of changes from reference visit; exact Jonckheere-Terpstra testa - Comparisons between each IgPro20 dose group and placebo group, and the comparison between the two IgPro20 dose groups of changes from reference visit; Wilcoxon rank sum testb | Overall: - Descriptive statistics |
Patient preference for treatment questionnaire | |||
 |  | By treatment: - Descriptive statistics |  |