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Table 6 PRO mean changes from baseline to week 52, reported by patients experiencing ≥ 1 acute exacerbation and those experiencing no acute exacerbations over the study period (analysis 2)

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

No acute exacerbations

≥ 1 acute exacerbation

SGRQ total score

3.18 (n = 808)

16.53** (n = 28)

SGRQ symptom score

1.93 (n = 829)

11.09 (n = 29)

SGRQ activity score

4.53 (n = 821)

12.44 (n = 28)

SGRQ impacts score

3.13 (n = 818)

21.27*** (n = 28)

UCSD-SOBQ

6.20 (n = 735)

22.00* (n = 23)

CASA-Q cough symptom scorea

−0.63 (n = 835)

0.86 (n = 29)

CASA-Q cough impact scorea

−2.37 (n = 835)

− 8.94 (n = 29)

EQ-5D VASa

− 3.65 (n = 821)

−7.31 (n = 29)

  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 < 0.001 vs ‘no acute exacerbations’ group
  3. aDecrease in score indicates worsening health