Table 3 Adverse events in subgroups by use of restricted or prohibited immunomodulatory or antifibrotic therapies
From: Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases
Restricted/prohibited medication use | No restricted/prohibited medication use | |||
|---|---|---|---|---|
Nintedanib (n = 39) | Placebo (n = 80) | Nintedanib (n = 293) | Placebo (n = 251) | |
Any adverse event | 39 (100.0) | 78 (97.5) | 278 (94.9) | 218 (86.9) |
Most frequent adverse eventsa | ||||
Diarrhea | 27 (69.2) | 19 (23.8) | 195 (66.6) | 60 (23.9) |
Nausea | 12 (30.8) | 10 (12.5) | 84 (28.7) | 21 (8.4) |
Bronchitis | 14 (35.9) | 20 (25.0) | 27 (9.2) | 27 (10.8) |
Nasopharyngitis | 3 (7.7) | 10 (12.5) | 41 (14.0) | 30 (12.0) |
Dyspnea | 8 (20.5) | 19 (23.8) | 28 (9.6) | 25 (10.0) |
Vomiting | 8 (20.5) | 3 (3.8) | 53 (18.1) | 14 (5.6) |
Cough | 5 (12.8) | 16 (20.0) | 28 (9.6) | 28 (11.2) |
Decreased appetite | 6 (15.4) | 6 (7.5) | 42 (14.3) | 11 (4.4) |
Headache | 4 (10.3) | 9 (11.3) | 31 (10.6) | 14 (5.6) |
Alanine aminotransferase increased | 6 (15.4) | 5 (6.3) | 37 (12.6) | 7 (2.8) |
Progression of ILDb | 8 (20.5) | 25 (31.3) | 8 (2.7) | 14 (5.6) |
Weight decreased | 4 (10.3) | 3 (3.8) | 37 (12.6) | 8 (3.2) |
Aspartate aminotransferase increased | 6 (15.4) | 5 (6.3) | 32 (10.9) | 7 (2.8) |
Abdominal pain | 3 (7.7) | 2 (2.5) | 31 (10.6) | 6 (2.4) |
Serious adverse eventc | 27 (69.2) | 45 (56.3) | 80 (27.3) | 65 (25.9) |
Fatal adverse event | 3 (7.7) | 8 (10.0) | 8 (2.7) | 9 (3.6) |
Adverse event leading to permanent treatment discontinuation | 8 (20.5) | 10 (12.5) | 57 (19.5) | 24 (9.6) |