Table 3.
Total Number of Events and Percentage Agreement for Phase 3 Ambulatory Study by Subgroup and Measure
| Phase 3 Ambulatory Evaluation 7 days |
Phase 3 Ambulatory Evaluation 1st 24 hours |
|||||
|---|---|---|---|---|---|---|
| Midlife VMS (n = 20) |
Midlife no VMS (n = 10) |
Young no VMS (n = 5) |
Midlife VMS (n = 5) |
Midlife no VMS (n = 5) |
Young no VMS (n = 5) |
|
| Bahr Monitor™ | ||||||
| Total # event marks* | 705 | 10 | 6 | 32 | 2 | 5 |
| Total # monitor VMS* | 2286 | 673 | 512 | 111 | 71 | 92 |
| Bahr Monitor™ to Event Mark | ||||||
| Event mark + monitor | 439 | 2 | 0 | 25 | 0 | 0 |
| Event mark only | 266 | 8 | 6 | 7 | 2 | 5 |
| Monitor only | 1847 | 671 | 512 | 86 | 71 | 92 |
| % event marks with monitor-recorded VMS | 59% | 20% | 0% | 78% | 0% | 0% |
| % monitor-recorded VMS with event mark | 19% | <1% | 0% | 23% | 0% | 0% |
| Biolog™ Monitor | NA | NA | NA | |||
| Total event marks* | 50 | 14 | 14 | |||
| Total monitor VMS* | 49 | 55 | 42 | |||
| Biolog™ Monitor to Event Mark | NA | NA | NA | |||
| Event mark + monitor | 22 | 3 | 3 | |||
| Event mark only | 28 | 11 | 11 | |||
| Monitor only | 27 | 52 | 39 | |||
| % event marks with monitor-recorded VMS | 44% | 21% | 21% | |||
| % monitor-recorded VMS with event mark | 45% | 5% | 7% | |||
| Bahr™ Monitor to Biolog™ Monitor | NA | NA | NA | |||
| Bahr™ + Biolog™ | 39 | 23 | 29 | |||
| Bahr™ only | 72 | 48 | 63 | |||
| Biolog™ only | 10 | 32 | 13 | |||
| % agreement | 32% | 22% | 28% | |||
VMS = vasomotor symptom (hot flash, night sweat).
NA = not applicable, Biolog worn only with Indianapolis site field participants.
*
Total event marks and total monitor VMS = number of each after collating to remove duplicate events. Events marks in non-VMS groups can be interpreted as false button presses.