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) |