TABLE 7.
Observed and PD model-predicted EBA as rise in TTP for CL-010 and CL-007
| Groupa | Mean (SD) value forb
: |
|||||
|---|---|---|---|---|---|---|
| EBA0–2 |
EBA2–14 |
EBA0–14 |
||||
| Obs [n] | Pred | Obs [n] | Pred | Obs [n] | Pred | |
| CL-010 | ||||||
| 50 mg | 1.483 (8.153) [15] | 1.992 (1.833) | 2.958 (2.652) [13] | 2.728 (2.340) | 2.621 (2.534) [13] | 2.623 (2.265) |
| 100 mg | −1.345 (8.586) [14] | 3.037 (2.477) | 5.744 (3.973) [15] | 3.875 (3.015) | 4.969 (3.644) [14] | 3.756 (2.935) |
| 150 mg | 4.867 (12.755) [15] | 3.634 (2.832) | 4.594 (5.035) [15] | 4.489 (3.363) | 4.633 (3.687) [15] | 4.367 (3.284) |
| 200 mg | 3.096 (8.202) [13] | 4.024 (3.062) | 5.391 (3.608) [13] | 4.875 (3.580) | 4.640 (3.447) [16] | 4.753 (3.503) |
| CL-007 | ||||||
| 200 mg | 1.115 (15.256) [13] | 4.024 (3.062) | 3.833 (2.954) [11] | 4.875 (3.580) | 3.818 (2.327) [12] | 4.753 (3.503) |
| 600 mg | 5.788 (12.173) [13] | 5.126 (3.710) | 5.09 (2.768) [13] | 5.903 (4.160) | 4.776 (2.879) [14] | 5.792 (4.093) |
| 1,000 mg | 2.795 (9.230) [11] | 5.429 (3.890) | 4.069 (1.916) [12] | 6.169 (4.313) | 4.865 (3.461) [13] | 6.063 (4.250) |
| 1,200 mg | 1.400 (7.659) [15] | 5.511 (3.939) | 4.868 (3.224) [12] | 6.240 (4.354) | 4.440 (2.169) [12] | 6.136 (4.292) |
a
Pretomanid treatment group.
b
The values shown represent the rise in time to positivity (TTP) in hours per day during treatment days 0 to 2 (EBA0–2), 2 to 14 (EBA2–14), and 0 to 14 (EBA0–14) for the CL-010 and CL-007 studies. Obs, observed value; [n], number of participants for observed data; Pred, predicted value (sample size equal to 10,000). Observed values for the CL-007 and CL-010 studies are from references 13 and 14, respectively, by Diacon et al.