Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)

A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event.

Time frame: Up to 22 weeks

Percentage of Participants With TE SAEs

A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event

Time frame: Up to 22 weeks

Number of Participants With TE Adverse Events of Special Interests (AESIs)

The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis \[e.g., localized thrombosis associated with vascular access\] was not considered an AESI), and Severe hypersensitivity including anaphylaxis.

Time frame: Up to 22 weeks

Percentage of Participants With TE-AESIs

The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis \[e.g., localized thrombosis associated with vascular access\] was not considered an AESI), and Severe hypersensitivity including anaphylaxis.

Time frame: Up to 22 weeks

Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma

Time frame: At Day 36 and Day 92 after the first treatment