Table 1.
Radiological Assessment and Availability of Surgical Lung Biopsy in Patients Treated in the INPULSIS Trials
| Nintedanib (n = 638) | Placebo (n = 423) | Total (n = 1061) | |
|---|---|---|---|
| Surgical lung biopsy available, n (%) | 144 (22.6)* | 85 (20.1)* | 229 (21.6)* |
| Radiological assessment, n (%) | |||
| Criteria A, B, and C | 264 (41.4)* | 199 (47.0)* | 463 (43.6)* |
| No surgical lung biopsy | 224 (35.1)* | 175 (41.4)* | 399 (37.6)* |
| Criteria A and C | 62 (9.7)* | 42 (9.9)* | 104 (9.8)* |
| No surgical lung biopsy | 57 (8.9)* | 38 (9.0)* | 95 (9.0)* |
| Criteria B and C | 296 (46.4) | 172 (40.7) | 468 (44.1) |
| No surgical lung biopsy | 213 (33.4)† | 125 (29.6)† | 338 (31.9)† |
| Did not fulfill radiological inclusion criteria (diagnosed based on surgical lung biopsy) | 16 (2.5)* | 10 (2.4)* | 26 (2.5)* |
Criterion A: definite honeycomb lung destruction with basal and peripheral predominance; criterion B: presence of reticular abnormality and traction bronchiectasis consistent with fibrosis with basal and peripheral predominance; criterion C: atypical features absent, specifically nodules and consolidation; ground glass opacity, if present, is less extensive than reticular opacity pattern.
*
Patients with honeycombing and/or biopsy (229 with biopsy, 399 [criteria A, B, and C] + 95 [criteria A and C] with honeycombing but not biopsy).
†
Patients without honeycombing or biopsy.