Table 6.
Kaplan–Meier estimates of response rate to primary and secondary end points in patients (n = 116)
End point | Group | n | Median response time (weeks) | 95% CI | P value |
---|---|---|---|---|---|
Primary | PM | 10 | 23.3 | 21.5, 24.9 | |
IM | 92 | 18.3 | 17.0, 19.7 | 0.026 | |
EM | 14 | 13.2 | 9.3, 17.1 | ||
Secondary | PM | 10 | 18.5 | 16.8, 22.3 | |
IM | 92 | 12.7 | 11.3, 14.1 | 0.006 | |
EM | 14 | 8.6 | 5.3, 11.9 |
The primary end point was complete remission after 6 months of treatment. Secondary end points included response (defined as partial remission), changes in clinical parameters (including proteinuria, serum albumin, serum creatinine and serum C3 values), and adverse effects (including leukopenia, infections, GI symptoms, amenorrhoea, hair loss, liver function disorder, transient increase in serum creatinine level, etc).