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Table 4 Subgroup analyses by endpoint

From: Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial

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

      
  1. IgG immunoglobulin G, INCAT Inflammatory Neuropathy Cause and Treatment, IVIg intravenous immunoglobulin, MRC Medical Research Council, I-RODS Inflammatory-Rasch-built Overall Disability Scale
  2. aFor Japanese subjects only
  3. bThis subgroup analysis will only be conducted if the group size is ≥ 30
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Trials

ISSN: 1745-6215