Table 4.
Incidence of Shifts in Electrolytes from Normal* at Screening Test to High at Post-Screening Visits (Safety Set)
| Variable | TJP-008-2 (n=97) | TJP-008-1 (n=98) | 2LPEG (n=98) |
|---|---|---|---|
| Sodium | |||
| Visit 2 (baseline) | 0 | 1 (1.0) | 0 |
| Visit 3 (colonoscopy day) | 4 (4.2) | 1 (1.0) | 0 |
| Visit 4 (7 days after colonoscopy) | 0 | 0 | 0 |
| Potassium | |||
| Visit 2 (baseline) | 6 (6.2) | 1 (1.0) | 3 (3.1) |
| Visit 3 (colonoscopy day) | 11 (11.3) | 17 (17.3) | 0 |
| Visit 4 (7 days after colonoscopy) | 2 (2.1) | 1 (1.0) | 2 (2.0) |
| Chloride | |||
| Visit 2 (baseline) | 9 (9.3) | 4 (4.1) | 5 (5.1) |
| Visit 3 (colonoscopy day) | 51 (52.6) | 47 (48.0) | 15 (15.3) |
| Visit 4 (7 days after colonoscopy) | 6 (6.2) | 4 (4.1) | 7 (7.1) |
Data are presented as the number (%).
TJP-008-2, TJP-008 administered as an evening/morning regimen; TJP-008-1, TJP-008 administered as a morning-only regimen; 2LPEG, 2 L polyethylene glycol with ascorbate.
*The upper limit of normal: sodium, 145 mmol/L; potassium, 5 mmol/L; chloride, 105 mmol/L.