Table 3.
Non‐parametric bootstrapped‐based parameter estimates of the placebo and drug effect model relating RBP‐7000 total active moiety exposure to total PANSS score
| Description | Estimate [95% CI] | BSV a [95% CI] | Estimate [95% CI] | BSV a [95% CI] (%Shrinkage) |
|---|---|---|---|---|
| Placebo model | Exposure response model | |||
| BSL – Baseline PANSS | 94.0 [92.3, 95.7] | 6.9 [5.67, 8.36] | 94.9 [93.9, 95.8] | 7.0 [6.1, 7.9] (17.3) |
| RUV – Residual variability | 5.5 [4.4, 6.5] | 5.5 [4.9, 6.1] | — | |
| PMAX – Max placebo effect | 0.06 [0.02, 0.10] | 0.1 [0.09, 0.15] | 0.06 [0.04, 0.09] | 0.014 [0.01,0.018] (18.6) |
| TPROG – Time to reach Max CFB (weeks) | 1.9 [1.8, 2.0] | — | 1.7 [1.06, 2.0] | — |
| POW – Weibull shape parameter | 10.0 [2.9, 17.6] | — | 2.1 [1.1, 10.1] | — |
| DRIFT – Linear drift | ‐0.70 [−1.1, −0.26] | 1.4 [0.8, 1.8] | ‐1.2 [−1.5, −1.0] | 1.3 [1.0, 1.6] (32.4) |
| E max – Maximum drug effect | 94.0 [92.3, 95.7] | 6.9 [5.67, 8.36] | 0.054 [0.02, 0.09] | — |
| EC 50 – Concentration to 50% of E max (ng ml −1 ) | 5.50 [4.4, 6.5] | 4.6 [0.18, 33.4] | — | |
BSV, between‐subject variability; CI, confidence interval
a
All are additive variability parameters, hence reporting standard deviation in the same unit as parameter