Table 5.
Number of Noise Events Detected Under Subsampling for Metastatic Disease Studies
| Study and Sampling Method | No. of Noise Events |
||||
|---|---|---|---|---|---|
| 200 Patients | 300 Patients | 400 Patients | 500 Patients | 600 Patients | |
| Grade 3+ events | |||||
| AVAiL | |||||
| Random by patient* | 9 | 4.3 | 2.4 | 1.2 | 0.3 |
| Random by center*† | 5.4 | 2.8 | 1.5 | 0.7 | 0.2 |
| Biggest centers† | 5 | 0 | 0 | 0 | 0 |
| First patients enrolled | 16 | 9 | 2 | 0 | 0 |
| AVF2107g | |||||
| Random by patient* | 13.2 | 7.6 | 4.9 | 3.3 | 2.3 |
| Random by center*† | 8.8 | 5.1 | 3.6 | 2.5 | 1.6 |
| Biggest centers† | 13 | 5 | 1 | 1 | 1 |
| First patients enrolled | 8 | 3 | 2 | 2 | 0 |
| ECOG 4599 | |||||
| Random by patient* | 9.9 | 5.8 | 3.9 | 2.6 | 1.6 |
| Random by center*† | 6.7 | 4.3 | 2.8 | 2 | 1.2 |
| Biggest centers† | 3 | 2 | 1 | 2 | 2 |
| First patients enrolled | 5 | 4 | 1 | 2 | 1 |
| EGF30001 | |||||
| Random by patient* | 12 | 7 | 4 | 2 | NA |
| Random by center*† | 8 | 5 | 3 | 1 | NA |
| Biggest centers† | 6 | 4 | 1 | 1 | NA |
| First patients enrolled | 4 | 4 | 3 | 0 | NA |
| JMDB | |||||
| Random by patient* | 0.448 | 0.39 | 0.422 | 0.528 | 0.139 |
| Random by center*† | 0.534 | 0.387 | 0.449 | 0.373 | 0.17 |
| Biggest centers† | 1 | 2 | 1 | 1 | 1 |
| First patients enrolled | 1 | 2 | 3 | 3 | 2 |
| Grade 1 to 2 events | |||||
| AVAiL | |||||
| Random by patient* | 5 | 1.8 | 1 | 0.2 | 0 |
| Random by center*† | 3.9 | 1.9 | 0.8 | 0.3 | 0 |
| Biggest centers† | 1 | 0 | 1 | 0 | 0 |
| First patients enrolled | 7 | 1 | 1 | 0 | 0 |
NOTE. Noise event quantities in bold are ≤ 3.
Abbreviations: AVAiL, Avastin in Lung; ECOG, Eastern Cooperative Oncology Group; NA, not applicable.
*
Noise events for random sampling methods are reported as mean numbers determined from 1,000 simulations.
†
Sample sizes are approximate due to analysis structure for sampling by center methods.