Table 2.
Baseline Characteristics by Subgroup
| Honeycombing on HRCT and/or Confirmation of UIP Pattern by Surgical Lung Biopsy |
No Honeycombing or Surgical Lung Biopsy |
|||
|---|---|---|---|---|
| Nintedanib (n = 425) | Placebo (n = 298) | Nintedanib (n = 213) | Placebo (n = 125) | |
| Age, yr, mean (SD) | 66.3 (8.1) | 66.9 (7.9) | 67.2 (8.1) | 67.2 (7.9) |
| Male, n (%) | 341 (80.2) | 238 (79.9) | 166 (77.9) | 96 (76.8) |
| Race, n (%) | ||||
| White | 228 (53.6) | 165 (55.4) | 132 (62.0) | 83 (66.4) |
| Asian | 145 (34.1) | 105 (35.2) | 49 (23.0) | 23 (18.4) |
| Black | 2 (0.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Missing* | 50 (11.8) | 28 (9.4) | 32 (15.0) | 19 (15.2) |
| Former or current smoker, n (%) | 327 (76.9) | 221 (74.2) | 137 (64.3) | 80 (64.0) |
| Time since diagnosis, yr, mean (SD) | 1.7 (1.4) | 1.5 (1.3) | 1.5 (1.3) | 1.7 (1.4) |
| Presence of centrilobular emphysema, n (%)† | 192 (45.2) | 132 (44.3) | 62 (29.1) | 34 (27.2) |
| FVC, ml, mean (SD) | 2,690 (715) | 2,738 (809) | 2,760 (835) | 2,702 (815) |
| FVC, % predicted, mean (SD) | 79.1 (17.4) | 79.6 (17.9) | 81.1 (18.0) | 78.6 (19.1) |
| FEV1/FVC ratio, %, mean (SD) | 81.7 (6.0) | 81.7 (6.2) | 81.5 (5.6) | 81.7 (5.5) |
| DlCO, % predicted, mean (SD) | 46.4 (13.6) | 46.0 (12.7) | 49.4 (13.2) | 49.2 (14.8) |
| SGRQ total score, mean (SD)‡ | 39.4 (19.4) | 40.1 (18.5) | 39.7 (18.6) | 38.3 (18.7) |
Definition of abbreviations: DlCO = diffusing capacity of the lung for carbon monoxide; HRCT = high-resolution computed tomography; SGRQ = St. George’s Respiratory Questionnaire; UIP = usual interstitial pneumonia.
*
In France, regulations did not permit the collection of data on race.
†
Based on qualitative assessment of HRCT scans.
‡
n = 415 for nintedanib and n = 295 for placebo in confirmation of UIP by surgical lung biopsy subgroup; n = 209 for nintedanib and n = 124 for placebo in features of possible UIP and traction bronchiectasis on HRCT and no biopsy.