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) |