Adverse events reported in the pooled population treated with nintedanib and in nintedanib-treated and placebo-treated patients in the INPULSIS trials
| Pooled population treated with nintedanib (n=1126) | INPULSIS | |||||
| Nintedanib (n=638) | Placebo (n=423) | |||||
| Events, n | Event rate (per 100 patient exposure-years) | Events, n | Event rate (per 100 patient exposure-years) | Events, n | Event rate (per 100 patient exposure-years) | |
| Diarrhoea | 2084 | 76.5 | 671 | 112.6 | 106 | 25.6 |
| Nausea | 489 | 18.0 | 208 | 34.9 | 29 | 7.0 |
| Nasopharyngitis | 410 | 15.1 | 117 | 19.6 | 91 | 22.0 |
| Bronchitis | 395 | 14.5 | 92 | 15.5 | 62 | 15.0 |
| Cough | 359 | 13.2 | 96 | 16.1 | 67 | 16.2 |
| Progression of IPF* | 350 | 12.9 | 70 | 11.8 | 73 | 17.7 |
| Vomiting | 304 | 11.2 | 102 | 17.1 | 11 | 2.7 |
| Upper respiratory tract infection | 274 | 10.1 | 72 | 12.1 | 55 | 13.3 |
| Dyspnoea | 253 | 9.3 | 50 | 8.4 | 51 | 12.3 |
| Weight decreased | 230 | 8.4 | 64 | 10.7 | 15 | 3.6 |
| Decreased appetite | 225 | 8.3 | 75 | 12.6 | 26 | 6.3 |
| Abdominal pain | 168 | 6.2 | 68 | 11.4 | 10 | 2.4 |
| Lower respiratory tract infection | 164 | 6.0 | 47 | 7.9 | 22 | 5.3 |
| Respiratory tract infection | 160 | 5.9 | 33 | 5.5 | 28 | 6.8 |
| Pneumonia | 159 | 5.8 | 40 | 6.7 | 31 | 7.5 |
| Fatigue | 153 | 5.6 | 44 | 7.4 | 35 | 8.5 |
Adverse events with event rate >5 per 100 patient exposure-years in the pooled population are shown.
*Corresponds to MedDRA preferred term ‘IPF’, which included disease worsening and acute exacerbations.
IPF, idiopathic pulmonary fibrosis; MedDRA, Medical Dictionary for Regulatory Activities.