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Table 2 Patients with FEV1 decline or SGRQ deterioration in the total population

From: Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial

 

Patients with confirmed FEV1decline or SGRQ deterioration at time points after the initial decline (available assessments)

Months after confirmed FEV1decline or SGRQ increase

6

12

18

24

30

36

42

48

FEV1decline

 No. of patients with decline, n (%)

1924/1924 (100)

1239/1661 (74.6)

1091/1447 (75.4)

895/1199 (74.6)

754/966 (78.1)

604/755 (80.0)

419/549 (76.3)

280/343 (81.6)

 Mean FEV1 change from baseline, mL (SD)

−223 (114)

−193 (176)

−202 (187)

−214 (195)

−237 (212)

−256 (224)

−258 (230)

−280 (224)

 Median FEV1 change from baseline mL (min, max)

−190 (−1090, −40)

−180 (−1240, 850)

−200 (−1000, 0.630)

−210 (−1070, 0.740)

−240 (−1190, 650)

−240 (−1200, 490)

−250 (−980, 460)

−270 (−920, 670)

SGRQ deterioration

 No. of patients with deterioration, n (%)

1785/1785 (100)

1140/1510 (75.5)

941/1301 (72.3)

776/1067 (72.7)

629/843 (74.6)

462/617 (74.9)

303/388 (78.1)

 

 Mean SGRQ change from baseline (SD)

12.5 (7.5)

10.6 (10.7)

10.2 (11.4)

10.7 (12.3)

11.3 (12.6)

11.8 (12.8)

12.3 (12.8)

 

 Median SGRQ score change from baseline (min, max)

10.5 (4.0, 53.1)

9.5 (−48.4, 53.9)

9.3 (−44.2, 67.8)

10.2 (−44.5, 69.6)

10.7 (−36.6, 54.6)

10.9 (−33.8, 50.1)

11.9 (−29.8, 47.3)

 
  1. For patients with confirmed decline at Month 1, their assessments at Months 6, 12, 18, 24, 30, 36, 42 and 48 are used as time from first confirmed deterioration. Unscheduled visits were excluded for this analysis. Only patients with confirmed FEV1 decline or confirmed SGRQ deterioration and available assessments at each time point after the deterioration were included in the analysis
  2. FEV1 forced expiratory volume in 1 s, SD standard deviation, SGRQ St. George’s Respiratory Questionnaire