Table 5.
Baseline | Week 8a(end of treatment phase) | Week 10b(end of FU phase) | |
---|---|---|---|
Morning cortisol levels (μg/dL), mean (SD) | 11.5 (4.5) | 11.2 (4.4) | 10.0 (4.8) |
Deviation from normal rangec, n/N (%) | |||
Morning cortisol levels within normal range | 50/61 (82.0) | 52/61 (85.2) | 37/50 (74.0) |
Morning cortisol levels below normal range | 5/61 (8.2) | 6/61 (9.8) | 10/50 (20.0) |
Morning cortisol levels above normal range | 6/61 (9.8) | 3/61 (4.9) | 3/50 (6.0) |
aAssessed using the SAF and LOCF.
bAssessed using the FU analysis set.
cDefined as 6.2–18.0 μg/dL.
FU: follow-up; LOCF: last observation carried forward; SAF: safety analysis set; SD: standard deviation.