Table 4.
Subgroup analyses by endpoint
| Subgroup | Primary efficacy analysis of Relapse rate | INCAT total score | Mean grip strength (dominant/ nondominant hand) | I-RODS | MRC sum score | Time to relapse or withdrawal for any other reason | IgG serum levels |
|---|---|---|---|---|---|---|---|
| Sex (male/female) | X | X | X | X | X | X | |
| Age group (≥18 years to ≤ 65 years, and > 65 years) | X | X | X | X | X | X | |
| Prestudy IVIg treatment modality (IVIg maintenance therapy, acute IVIg therapy)a | X | X | X | X | X | X | |
| Region (Japan/non-Japan) | X | X | |||||
| Relapse status (yes/no) | X | ||||||
| IVIg Dependency criterion: I-RODS or grip strength | Xb |
IgG immunoglobulin G, INCAT Inflammatory Neuropathy Cause and Treatment, IVIg intravenous immunoglobulin, MRC Medical Research Council, I-RODS Inflammatory-Rasch-built Overall Disability Scale
aFor Japanese subjects only
bThis subgroup analysis will only be conducted if the group size is ≥ 30