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Table 3 Serious adverse events in the INSTAGE and INPULSIS trials

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)

  1. Data are n (%) of patients with ≥1 such event. In INPULSIS, events with onset between the first dose of trial drug and day 195 (or between the first dose and 28 days after the last dose for patients who discontinued trial drug before week 24) were included. In INSTAGE, events with onset between the first dose and up to 28 days after the last dose of trial drug were included. aEvents that resulted in death, were life-threatening, resulted in hospitalisation or prolonged hospitalisation, resulted in persistent or clinically significant disability or incapacity, were a congenital anomaly or birth defect, or were deemed serious for any other reason. bReported in ≥1.5% of patients in any of the groups shown, based on MedDRA preferred terms. cCorresponds to MedDRA term ‘IPF’, which included disease worsening and acute exacerbations