Table 3:
Summary of Histology for Various Treatment Populations and Subgroup Analysis
| Outcome Measure | Population, n | P-value | Reduction | |
|---|---|---|---|---|
| IMGX003 | Placebo | |||
|
| ||||
| Prospective: | ||||
| Vh:Cd (mITT)(1) | 21 | 22 | .057 | 88% |
| IEL (mITT) | 21 | 22 | .018 | 60% |
| Retrospective: | ||||
| VCIEL | 21 | 22 | .010 | 90% |
| Marsh-Oberhuber | 21 | 22 | .035 | 75% |
| Vh:Cd (Subgroup)(2) | 17 | 18 | .050 | 98% |
| Vh:Cd (Subgroup)(3) | 19 | 20 | .027 | 90% |
| Vh:Cd (Subgroup)(4) | 18 | 18 | <.001 | 100% |
(1)
Finnish method for average Vh:Cd is average of individual Sum(Vh)/Sum(Cd) and is the method used in the predecessor study ALV003–1021. Mayo Clinic method for average Vh:Cd is average of individual Vh:Cd ratios and gives p = .076 and reduction of 86%.
(2)
Subgroup analysis: Drop 4 patients (about 20%) in each group with lowest GIP concentration in urine.
(3)
Drop highest and lowest ΔVh:Cd values in each group.
(4)
Subgroup analysis: Exclude patients with VCIEL < 2.0 at baseline.