Table 4 Effect size (withdrawn compared with active treatment) 95% confidence intervals and denominators for study outcomes
| Â | Outcome | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Study | Whether exacerbation or not during study period (odds ratio) | Time to first exacerbation (mean (M) or median (m)) | Frequency of exacerbation requiring course of steroids or antibiotics(rate ratio (rr) or hazard ratio (hr)) | Lung function(mean difference in change from baseline) | Total SGRQ score (mean difference in change from baseline) | Walking distance in 6 minutes (mean difference in change from baseline) | Borg exercise tolerance test (units) | |||||||
COPE | 1.5 | (0.9 to 2.5) (n = 242)a | 34.6 (M) | (15.4 to 53.8) (not clear) | 1.5 (hr) | (1.1 to 2.1) (not clear) | -38 ml | (-79.5 to 1.6) (n = 242) | 2.5 | (0.4 to 4.6) (not clear) | 9.4 m | (-4.5 to 23.2) (n = 172) | -0.3 | (-0.7 to 0.3) (n = 173) |
COSMIC | 0.9 | (0.6 to 1.4) (n = 373)b | Not measured | 1.2 (rr) | (0.9 to 1.5) (n = 373) | -4.1% | (-6.6 to -1.6) (not clear) | 0.9 | (-.1.3 to 3.1) (not clear) | Not measured | Not measured | |||
WISP | 1.0 | (0.6 to 1.8) (n = 260)b | 19 (m) | Not givenc | 1.3 (rr) | (1.0 to 1.6) (n = 260) | -23 ml | (-101.5 to 55.5) (not clear) | -0.45 | Unable to estimate | Not measured | Not measured | ||
O'Brien | Not measured | Not measured | Not measured | -11.3% | (-23.4 to 0.8) | Not measured | -32 ft | (-771 to 707) | Unable to estimated | |||||