Most frequent adverse events reported in the INPULSIS trials (reproduced with permission from ref. 18)
| n (%) | Nintedanib (n=638) | Placebo (n=423) |
| Most frequent adverse events* | ||
| Diarrhoea | 398 (62.4) | 78 (18.4) |
| Nausea | 156 (24.5) | 28 (6.6) |
| Nasopharyngitis | 87 (13.6) | 68 (16.1) |
| Cough | 85 (13.3) | 57 (13.5) |
| Progression of IPF† | 64 (10.0) | 61 (14.4) |
| Bronchitis | 67 (10.5) | 45 (10.6) |
| Dyspnoea | 49 (7.7) | 48 (11.3) |
| Decreased appetite | 68 (10.7) | 24 (5.7) |
| Vomiting | 74 (11.6) | 11 (2.6) |
| Adverse events that most frequently led to permanent treatment discontinuation‡ | ||
| Progression of IPF† | 13 (2.0) | 21 (5.0) |
| Diarrhoea | 28 (4.4) | 1 (0.2) |
| Nausea | 13 (2.0) | 0 (0.0) |
| Decreased appetite | 9 (1.4) | 1 (0.2) |
| Pneumonia | 6 (0.9) | 1 (0.2) |
| Weight decreased | 6 (0.9) | 1 (0.2) |
| Abdominal pain | 5 (0.8) | 1 (0.2) |
| Vomiting | 5 (0.8) | 0 (0.0) |
| Asthenia | 4 (0.6) | 0 (0.0) |
| Increased alanine aminotransferase (ALT) | 4 (0.6) | 0 (0.0) |
Data shown are the number (%) of patients who received ≥1 dose of study medication who reported ≥1 such adverse event. Adverse events reported by the investigators were coded according to preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA).
*Adverse events reported in >10% of patients in the nintedanib and/or placebo group.
†Corresponds to the MedDRA preferred term ‘IPF’, which included disease worsening and IPF exacerbations.
‡Adverse events leading to permanent treatment discontinuation in >0.5% of patients in the nintedanib and/or placebo group.
IPF, idiopathic pulmonary fibrosis.