Table A6.
Number of Concomitant Medication Records
| Study (safety population analyzed) | Concomitant Medication Records (average No. per patient) |
Concomitant Medication Data Fields (average No. per patient) |
||
|---|---|---|---|---|
| No. | Avg | No. | Avg | |
| Metastatic studies | ||||
| AVF2107g (n = 788) | 20,998 | 26.6 | 83,992 | 106.6 |
| AVAiL (n = 656) | 11,957 | 18.2 | 47,828 | 72.9 |
| EGF30001 (n = 580) | 9,270 | 16.0 | 94,245 | 163.05 |
| JMDB (n = 1,669) | 24,168 | 14.5 | 120,840 | 72.4 |
| Adjuvant studies | ||||
| BIG 1-98 (n = 7,963) | 56,966 | 7.1 | 1,841,572 | 230 |
| HERA (n = 3,386) | 13,249 | 3.9 | 52,996 | 15.7 |
| Total | 136,608 | 9.1 | 2,241,473 | 148.6 |
NOTE. Concomitant medications were not collected in all patients in studies Eastern Cooperative Oncology Group 4599 and Cancer and Leukemia Group B 89803. Because of safety signals identified in previous aromatase inhibitor trials, concomitant medication collection in the BIG 1-98 trial included several additional targeted collections medications.
Abbreviations: AVAiL, Avastin in Lung; BIG, Breast International Group; HERA, HERceptin Adjuvant.