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Table 5 Mean changes from baseline to week 52 in all PROs, reported by patients with ≤ 5%, > 5 to ≤ 10%, or > 10% decline in FVC % predicted over the study period (analysis 1)

From: Health-related quality of life and symptoms in patients with IPF treated with nintedanib: analyses of patient-reported outcomes from the INPULSIS® trials

 

Mean change from baseline to week 52

≤ 5% decline in FVC

>  5 to ≤ 10% decline in FVC

>  10% decline in FVC

SGRQ total score

−0.18 (n = 477)

4.84** (n = 194)

13.10***, ‡ (n = 152)

SGRQ symptom score

−2.39 (n = 492)

7.46*** (n = 198)

9.40*** (n = 155)

SGRQ activity score

0.78 (n = 486)

5.75** (n = 196)

15.58***, ‡ (n = 154)

SGRQ impacts score

0.28 (n = 482)

4.02* (n = 198)

13.15***, ‡ (n = 153)

UCSD-SOBQ

3.02 (n = 441)

7.65** (n = 176)

15.85***, † (n = 132)

CASA-Q cough symptom scorea

2.47 (n = 495)

−3.90** (n = 201)

−5.27*** (n = 155)

CASA-Q cough impact scorea

1.38 (n = 495)

−6.48*** (n = 200)

−8.59*** (n = 156)

EQ-5D VASa

−0.69 (n = 490)

−4.78** (n = 197)

−10.83***, † (n = 151)

  1. CASA-Q cough and sputum assessment questionnaire (symptom and impact score), EQ-5D VAS EuroQoL 5-dimensional quality of life questionnaire visual analog scale, FVC forced vital capacity, PRO patient-reported outcome, SGRQ St George’s respiratory questionnaire (total, symptoms, activity and impacts score), UCSD-SOBQ University of California San Diego shortness of breath questionnaire
  2. *P < 0.05; **P < 0.01; and ***P < 0.0001 vs the group with ≤ 5% decline in FVC
  3. P < 0.01 and P < 0.0001 vs the group with > 5 to ≤ 10% decline in FVC
  4. aDecrease in score indicates worsening health