|
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
