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Primary outcomes of Phase II clinical trials (n=39)
| Number | Percent | |
|---|---|---|
| Interventional Model | ||
| Single Group Assignment | 26 | 66.7 |
| Parallel Assignment | 11 | 28.2 |
| Not Specified | 2 | 5.1 |
| Treatment Allocation | ||
| Non-randomized | 30 | 76.9 |
| Randomized | 9 | 23.1 |
| Masking | ||
| Open Label | 36 | 92.3 |
| Masked | 1 | 2.6 |
| Not Specified | 2 | 5.1 |
| Main Primary Endpoint | ||
| Progression-free Survival | 7 | 17.9 |
| Objective Response Rate | 23 | 59.0 |
| Clinical Benefit Rate | 2 | 5.1 |
| Relapse Rate | 2 | 5.1 |
| Safety / Toxicity | 2 | 5.1 |
| Efficacy | 3 | 7.7 |
