Table A4.
Average RDI in Safety and Per-Protocol Populations
| Average RDI | Treatment |
|
|---|---|---|
| BEP | T-BEP | |
| Safety population | ||
| No. of patients | 161 | 161 |
| Average RDI for BEP component | ||
| Median, % | 97.1 | 97.6 |
| Range, % | 48.8-103.3 | 19.2-103.5 |
| Q1-Q3, % | 92.2-98.8 | 91.9-98.8 |
| No. of patients with RDI ≥ 80% | 154 | 150 |
| % | 95.7 | 93.2 |
| No. of patients with RDI ≥ 90% | 134 | 124 |
| % | 83.2 | 77.0 |
| Average RDI for T-BEP | ||
| Median, % | 97.5 | |
| Range, % | 44.1-102.8 | |
| Q1-Q3, % | 90.3-98.8 | |
| No. of patients with RDI ≥ 80% | 149 | |
| % | 92.5 | |
| No. of patients with RDI ≥ 90% | 121 | |
| % | 75.2 | |
| Per-protocol population | ||
| No. of patients | 152 | 148 |
| Average RDI for BEP component | ||
| Median, % | 97.4 | 97.7 |
| Range, % | 48.8-103.3 | 19.2-103.5 |
| Q1-Q3, % | 92.1-98.8 | 92.3-98.8 |
| No. of patients with RDI ≥ 80% | 146 | 139 |
| % | 96.1 | 93.9 |
| No. of patients with RDI ≥ 90% | 126 | 117 |
| % | 82.9 | 79.1 |
| Average RDI for T-BEP | ||
| Median, % | 97.7 | |
| Range, % | 44.1-102.5 | |
| Q1-Q3, % | 92.1-98.8 | |
| No. of patients with RDI ≥ 80% | 138 | |
| % | 93.2 | |
| No. of patients with RDI ≥ 90% | 114 | |
| % | 77.0 | |
Abbreviations: BEP, bleomycin, etoposide, and cisplatin; Q, quartile; RDI, relative dose intensity; T-BEP, paclitaxel–bleomycin, etoposide, and cisplatin.