Changes from baseline in SGRQ total and domain scores at week 52 and corresponding effect sizes by changes in FVC >10% predicted and PGI-C at week 52
| Change from baseline in SGRQ score at week 52 | Deterioration in FVC >10% predicted at week 52 | Improvement in FVC >10% predicted at week 52 | Mean (SD) difference | P values | PGI-C score 1–2 (very much or much better) at week 52 | PGI-C score 6–7 (much or very much worse) at week 52 | Mean (SD) difference | P-values | ||||||||
| n | Mean (SD) | Effect size | n | Mean (SD) | Effect size | n | Mean (SD) | Effect size | n | Mean (SD) | Effect size | |||||
| Total | 152 | 13.1 (15.6) | 0.64 | 21 | −6.8 (15.2) | −0.35 | 19.9 (3.6) | <0.0001 | 116 | −9.7 (14.9) | −0.55 | 73 | 20.4 (16.6) | 1.20 | −30.1 (2.3) | <0.0001 |
| Activity domain | 154 | 15.6 (19.0) | 0.68 | 22 | −4.4 (17.2) | −0.22 | 19.9 (4.3) | <0.0001 | 118 | −7.5 (17.6) | −0.37 | 73 | 20.8 (20.8) | 1.11 | −28.3 (2.8) | <0.0001 |
| Impact domain | 153 | 13.2 (18.1) | 0.58 | 21 | −9.0 (18.2) | −0.41 | 22.1 (4.2) | <0.0001 | 116 | −10.6 (18.3) | −0.54 | 73 | 21.4 (18.3) | 1.12 | −32.0 (2.7) | <0.0001 |
| Symptoms domain | 155 | 9.4 (20.5) | 0.38 | 22 | −3.2 (20.6) | −0.14 | 12.6 (4.7) | 0.0076 | 118 | −9.1 (18.7) | −0.43 | 74 | 17.8 (21.4) | 0.92 | −27.0 (2.9) | <0.0001 |
FVC, forced vital capacity; PGI-C, Patient ’s Global Impression of Change; SGRQ, St George’s Respiratory Questionnaire.