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Table 4 Adverse events (reported irrespective of causality) in subgroups of patients by weight loss over 52 weeksa

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

  Weight loss ≤ 5% Weight loss > 5%
Nintedanib (n = 397) Placebo (n = 338) Nintedanib (n = 241) Placebo (n = 85)
Adverse event(s) 376 (94.7) 297 (87.9) 233 (96.7) 82 (96.5)
Most frequent adverse event(s)b
 Diarrhoea 216 (54.4) 56 (16.6) 177 (73.4) 22 (25.9)
 Progression of IPFc 30 (7.6) 41 (12.1) 34 (14.1) 20 (23.5)
 Dyspnoea 24 (6.0) 37 (10.9) 25 (10.4) 11 (12.9)
 Nausea 90 (22.7) 20 (5.9) 66 (27.4) 8 (9.4)
 Pneumonia 21 (5.3) 14 (4.1) 12 (5.0) 12 (14.1)
 Nasopharyngitis 46 (11.6) 59 (17.5) 41 (17.0) 9 (10.6)
 Decreased appetite 31 (7.8) 14 (4.1) 37 (15.4) 10 (11.8)
 Cough 57 (14.4) 45 (13.3) 28 (11.6) 12 (14.1)
 Bronchitis 43 (10.8) 33 (9.8) 24 (10.0) 12 (14.1)
 Vomiting 39 (9.8) 9 (2.7) 35 (14.5) 2 (2.4)
 Upper respiratory tract infection 40 (10.1) 33 (9.8) 18 (7.5) 9 (10.6)
 Abdominal pain 31 (7.8) 8 (2.4) 25 (10.4) 2 (2.4)
 Weight decreased 14 (3.5) 3 (0.9) 48 (19.9) 12 (14.1)
 Arthralgia 8 (2.0) 12 (3.6) 6 (2.5) 9 (10.6)
Adverse event(s) leading to treatment discontinuation 72 (18.1) 38 (11.2) 51 (21.2) 17 (20.0)
Severe adverse event(s)d 94 (23.7) 72 (21.3) 80 (33.2) 27 (31.8)
Serious adverse event(s)e 97 (24.4) 86 (25.4) 97 (40.2) 41 (48.2)
Fatal adverse event(s) 20 (5.0) 25 (7.4) 17 (7.1) 6 (7.1)
  1. Data are n (%) of patients with ≥1 such adverse event reported over 52 weeks plus a 4-week post-treatment follow-up period. aBased on the annual rate of decline in weight. bAdverse events by MedDRA preferred term reported in ≥10% of patients in ≥1 of the subgroups shown. cCorresponds to MedDRA term ‘IPF’, which included disease worsening and acute exacerbations. dEvent that was incapacitating or that caused an inability to work or to perform usual activities. eEvent 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