Table 3.
Safety Summary (Safety Set)
| Variable | TJP-008-2 (n=97) | TJP-008-1 (n=98) | 2LPEG (n=98), No. (%) |
|||
|---|---|---|---|---|---|---|
| No. (%) | p-value* | No. (%) | p-value† | |||
| Total number of treatment-related TEAEs | 16 | 18 | 11 | |||
| Patients with treatment-related TEAEs | 16 (16.5) | 0.287 | 15 (15.3) | 0.159 | 8 (8.2) | |
| Patients with specific treatment-related TEAEs‡ | ||||||
| Vomiting | 6 (6.2) | 0.065 | 3 (3.1) | 0.621 | 1 (1.0) | |
| Nausea | 2 (2.1) | NA | 3 (3.1) | NA | 0 | |
| Thirst | 2 (2.1) | 0.621 | 4 (4.1) | 0.369 | 1 (1.0) | |
| Patients with treatment-related severe TEAEs | 0 | 0 | 0 | |||
| Patients with treatment-related serious TEAEs | 0 | 0 | 0 | |||
| Deaths | 0 | 0 | 0 | |||
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; TEAE, treatment-emergent adverse event; NA, not available.
*TJP-008-2 vs 2LPEG: Pearson chi-square test or Fisher exact test; †TJP-008-1 vs 2LPEG: Pearson chi-square test or Fisher exact test; ‡Reported for at least 2% of patients in any treatment group.