Outcomes post-week 28 by clinically important deterioration (CID) status at week 28 (definition including St George's Respiratory Questionnaire (SGRQ) or COPD Assessment Test (CAT))
| CID-positive | CID-negative | Difference (CID-positive versus CID-negative) | |
| Definition including SGRQ | N=7008# | N=3055# | |
| Annual rates (95% CI) | % increase in rate (95% CI) | ||
| Rate of exacerbations | n=5860¶,+ | n=2729¶,+ | |
| Moderate/severe exacerbations after week 28 | 0.94 (0.90–0.98) | 0.54 (0.49–0.58) | 75 (60–92)§ |
| Severe exacerbations after week 28 | 0.14 (0.12–0.16) | 0.07 (0.06–0.09) | 96 (56–147)§ |
| Patients with event (%) | % increase in risk (95% CI) | ||
| Time to first exacerbation | n=5864¶,+,ƒ | n=2732¶,+,ƒ | |
| Moderate/severe exacerbations after week 28 | 1900 (32) | 548 (20) | 72 (56–89)§ |
| Severe exacerbations after week 28 | 391 (7) | 99 (4) | 79 (43–123)§ |
| Time to all-cause mortality | n=5887 | n=2732 | |
| All-cause mortality after week 28## | 77 (1) | 23 (<1) | 55 (−3–147)¶¶ |
| LS mean CFB (95% CI) | Difference (95% CI) | ||
| Trough FEV1 at week 52 mL | n=5359 | n=2557 | |
| 9 (2–15) | 152 (143–162) | −143 (−155– −132)§ | |
| SGRQ total score at week 52 | n=5298 | n=2516 | |
| −2.4 (−2.7– −2.0) | −9.8 (−10.3– −9.3) | 7.5 (6.8–8.1)§ | |
| CAT score at week 52 | n=5218 | n=2482 | |
| −1.2 (−1.3– −1.0) | −3.3 (−3.5– −3.0) | 2.1 (1.8–2.4)§ | |
| Definition including CAT | N=7304# | N=2759# | |
| Annual rates (95% CI) | % increase in rate (95% CI) | ||
| Rate of exacerbations | n=6150¶,++ | n=2439¶,++ | |
| Moderate/severe exacerbations after week 28 | 0.92 (0.88–0.96) | 0.54 (0.49–0.58) | 72 (56–89)§ |
| Severe exacerbations after week 28 | 0.15 (0.13–0.17) | 0.08 (0.06–0.10) | 91 (50–142)§ |
| Patients with event (%) | % increase in risk (95% CI) | ||
| Time to first exacerbation | n=6153¶,ƒ,++ | n=2443¶,ƒ,++ | |
| Moderate/severe exacerbations after week 28 | 1959 (32) | 489 (20) | 68 (52–86)§ |
| Severe exacerbations after week 28 | 402 (7) | 88 (4) | 78 (41–125)§ |
| Time to all-cause mortality | n=6176 | n=2443 | |
| All-cause mortality after week 28## | 82 (1) | 18 (<1) | 80 (8–200)§§ |
| LS mean CFB (95% CI) | Difference (95% CI) | ||
| Trough FEV1 at week 52 mL | n=5632 | n=2284 | |
| 14 (7–20) | 156 (146–167) | −142 (−155– −130)§ | |
| SGRQ total score at week 52 | n=5565 | n=2249 | |
| −3.2 (−3.6– −2.9) | −8.6 (−9.2– −8.0) | 5.4 (4.7–6.0)§ | |
| CAT score at week 52 | n=5502 | n=2198 | |
| −0.9 (−1.1– −0.8) | −4.1 (−4.4– −3.9) | 3.2 (2.9–3.5)§ | |
COPD: chronic obstructive pulmonary disease; N: number of patients with CID status available at week 28; LS: least squares; CFB: change from baseline; FEV1: forced expiratory volume in 1 s. #: number of patients who deteriorated on any of the CID components up to week 28 (CID-positive) or who did not deteriorate on any of the CID components up to week 28 (CID-negative) (if a patient has all missing on-treatment assessments for an end-point (trough FEV1, SGRQ and CAT) up to the time-point of interest, CID status was considered as missing for that patient, end-point and time-point); ¶: excludes those patients who discontinued prior to week 28; +: seven patients were excluded from the analysis due to missing covariates (CID-positive n=4; CID-negative n=3); §: p<0.001; ƒ: number of patients included in the Kaplan–Meier estimates; ##: post hoc analysis of all-cause mortality including off-treatment data following additional collection of vital status (providing data for 99.6% of the IMPACT trial population); ¶¶: p>0.05; ++: seven patients were excluded from the analysis due to missing covariates (CID-positive: n=3; CID-negative: n=4); §§: p<0.05. Positive differences in CAT score ≥2 units or SGRQ total score ≥4 units and negative differences in trough FEV1 ≥100 mL in magnitude indicate sustained clinically important worsening between the CID-positive and CID-negative subgroups (difference in change from baseline greater than the corresponding minimal clinically important differences [11, 12, 26]).