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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)
  1. Data are n (%) of patients with ≥ 1 such adverse event reported over 52 weeks (or until 28 days after last trial drug intake in patients who discontinued trial drug before week 52)
  2. aAdverse events, coded using preferred terms in the Medical Dictionary for Regulatory Activities, reported in > 10% of patients in either treatment group in the overall population
  3. bBased on the preferred term “interstitial lung disease” in the Medical Dictionary for Regulatory Activities
  4. cAdverse event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in persistent or clinically significant disability or incapacity, was a congenital anomaly or birth defect, or was deemed to be serious for any other reason