From: Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis
INPULSIS | INSTAGE | ||
---|---|---|---|
Nintedanib (n = 638) | Placebo (n = 423) | Nintedanib (n = 136) | |
Serious adverse eventsa | 107 (16.8) | 72 (17.0) | 44 (32.4) |
Most frequent serious adverse eventsb | |||
Progression of IPFc | 23 (3.6) | 21 (5.0) | 9 (6.6) |
Pneumonia | 14 (2.2) | 10 (2.4) | 8 (5.9) |
Pulmonary hypertension | 4 (0.6) | 7 (1.7) | 4 (2.9) |
Respiratory failure | 0 | 0 | 3 (2.2) |
Right ventricular failure | 0 | 0 | 3 (2.2) |
Pulmonary embolism | 3 (0.5) | 2 (0.5) | 2 (1.5) |
Lower respiratory tract infection | 1 (0.2) | 2 (0.5) | 2 (1.5) |
Respiratory tract infection | 0 | 2 (0.5) | 2 (1.5) |
Dyspnoea | 1 (0.2) | 2 (0.5) | 2 (1.5) |
Acute respiratory failure | 2 (0.3) | 1 (0.2) | 2 (1.5) |