TABLE 4

Summary of TEAEs (safety population)

PlaceboSAR156597 Q2WSAR156597 QW
Patients n109108108
Patients with any TEAE99 (90.8)102 (94.4)100 (92.6)
Most frequently reported TEAEs#
 IPF19 (17.4)19 (17.6)30 (27.8)
 Cough12 (11.0)22 (20.4)18 (16.7)
 Diarrhoea16 (14.7)23 (21.3)12 (11.1)
 Viral upper RTI16 (14.7)18 (16.7)12 (11.1)
 Bronchitis13 (11.9)18 (16.7)11 (10.2)
Patients with TEAEs by intensity
 Mild85 (78.0)83 (76.9)85 (78.7)
 Moderate70 (64.2)71 (65.7)76 (70.4)
 Severe22 (20.2)24 (22.2)42 (38.9)
Patients with any treatment-related TEAE35 (32.1)32 (29.6)35 (32.4)
Patients with any SAE26 (23.9)27 (25.0)46 (42.6)
Most frequently reported SAEs
 IPF10 (9.2)9 (8.3)22 (20.4)
 Pneumonia4 (3.7)3 (2.8)8 (7.4)
 Pulmonary hypertension02 (1.9)2 (1.9)
 Bronchitis1 (0.9)02 (1.9)
 Septic shock2 (1.8)01 (0.9)
 Pulmonary embolism2 (1.8)01 (0.9)
 Acute coronary syndrome1 (0.9)02 (1.9)
 Lung infection02 (1.9)0
 Respiratory failure002 (1.9)
 Hepatic congestion002 (1.9)
Patients with any treatment-related SAE5 (4.6)5 (4.6)3 (2.8)
Patients with any TEAE leading to death11 (10.1)6 (5.6)13 (12.0)
Most frequently reported TEAEs leading to death
 IPF6 (5.5)07 (6.5)
 Pneumonia1 (0.9)2 (1.9)0
 Septic shock2 (1.8)01 (0.9)
Patients with any TEAE leading to discontinuation15 (13.8)13 (12.0)23 (21.3)
Most frequently reported TEAEs leading to discontinuation
 IPF8 (7.3)4 (3.7)9 (8.3)
 Pulmonary hypertension02 (1.9)0
 Transient ischaemic attack02 (1.9)0

Data presented as n (%), unless otherwise stated. TEAE: treatment-emergent adverse event; Q2W: once every 2 weeks; QW: once every week; IPF: idiopathic pulmonary fibrosis; RTI: respiratory tract infection; SAE: serious adverse event. #: ≥15% patients in any arm; : >1 patient in any arm.