Table 6.
Proportion of patients in whom FVC% p fell below 50%, 40% or 30% at any time during the study by event type
| Patients falling | Event Type | Idebenone n (%) | Placebo n (%) | Hazard Ratio* (95% CI) |
| in FVC% p below | ||||
| 50% | first event | 4 of 20 (20%) | 7 of 16 (44%) | 0.34 (0.10, 1.18) |
| persistent | 3 of 20 (15%) | 4 of 16 (25%) | 0.48 (0.11, 2.16) | |
| 40% | first event | 4 of 24 (17%) | 4 of 20 (20%) | 0.58 (0.13, 2.60) |
| persistent | 4 of 24 (17%) | 4 of 20 (20%) | 0.61 (0.14, 2.74) | |
| 30% | first event | 4 of 29 (14%) | 7 of 28 (25%) | 0.59 (0.17, 2.10) |
| persistent | 3 of 29 (10%) | 6 of 28 (21%) | 0.51 (0.12, 2.15) | |
| any threshold** | first event | 10 of 29 (34%) | 16 of 28 (57%) | 0.51 (0.23, 1.14) |
| persistent | 8 of 29 (28%) | 12 of 28 (43%) | 0.60 (0.24, 1.49) |
Event type: “first event” analysis allows for subsequent improvement; “persistent” defined as a decline that stays below the threshold at all subsequent assessments until the end of the study. *Hazard Ratios from Cox model. **each patient is only counted once.