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Table 3 Adverse events (reported irrespective of causality) in subgroups of patients by BMI at baseline

From: Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

  BMI < 25 kg/m2 at baseline BMI ≥ 25 and < 30 kg/m2 at baseline BMI ≥ 30 kg/m2 at baseline
Nintedanib (n = 167) Placebo (n = 140) Nintedanib (n = 285) Placebo (n = 168) Nintedanib (n = 186) Placebo (n = 115)
Adverse event(s) 161 (96.4) 124 (88.6) 270 (94.7) 151 (89.9) 178 (95.7) 104 (90.4)
Most frequent adverse event(s)a
 Diarrhoea 102 (61.1) 24 (17.1) 176 (61.8) 33 (19.6) 115 (61.8) 21 (18.3)
 Nausea 37 (22.2) 7 (5.0) 71 (24.9) 11 (6.5) 48 (25.8) 10 (8.7)
 Progression of IPFb 25 (15.0) 28 (20.0) 28 (9.8) 25 (14.9) 11 (5.9) 8 (7.0)
 Nasopharyngitis 33 (19.8) 21 (15.0) 32 (11.2) 32 (19.0) 22 (11.8) 15 (13.0)
 Cough 16 (9.6) 16 (11.4) 38 (13.3) 32 (19.0) 31 (16.7) 9 (7.8)
 Decreased appetite 26 (15.6) 13 (9.3) 23 (8.1) 11 (6.5) 19 (10.2) 0
 Vomiting 25 (15.0) 7 (5.0) 25 (8.8) 1 (0.6) 24 (12.9) 3 (2.6)
 Bronchitis 12 (7.2) 8 (5.7) 32 (11.2) 20 (11.9) 23 (12.4) 17 (14.8)
 Dyspnoea 9 (5.4) 14 (10.0) 23 (8.1) 19 (11.3) 17 (9.1) 15 (13.0)
 Weight decreased 19 (11.4) 5 (3.6) 28 (9.8) 8 (4.8) 15 (8.1) 2 (1.7)
 Upper respiratory tract infection 17 (10.2) 14 (10.0) 23 (8.1) 17 (10.1) 18 (9.7) 11 (9.6)
 Fatigue 9 (5.4) 14 (10.0) 14 (4.9) 13 (7.7) 17 (9.1) 6 (5.2)
Adverse event(s) leading to treatment discontinuation 43 (25.7) 19 (13.6) 50 (17.5) 19 (11.3) 30 (16.1) 17 (14.8)
Severe adverse event(s)c 44 (26.3) 34 (24.3) 81 (28.4) 42 (25.0) 49 (26.3) 23 (20.0)
Serious adverse event(s)d 61 (36.5) 37 (26.4) 82 (28.8) 54 (32.1) 51 (27.4) 36 (31.3)
Fatal adverse event(s) 8 (4.8) 13 (9.3) 18 (6.3) 9 (5.4) 11 (5.9) 9 (7.8)
  1. Data are n (%) of patients with ≥1 such adverse event reported over 52 weeks plus a 4-week post-treatment follow-up period. aAdverse events by MedDRA preferred term reported in ≥10% of patients in ≥1 of the subgroups shown. bCorresponds to MedDRA term ‘IPF’, which included disease worsening and acute exacerbations. cEvent that was incapacitating or that caused an inability to work or to perform usual activities. dEvent that resulted in death, was immediately life-threatening, resulted in persistent or clinically significant disability or incapacity, required or prolonged hospitalisation, was related to a congenital anomaly or birth defect, or was deemed serious for any other reason