Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study

Table 3 Adverse events related to the ENB index procedure or devices (1 Month Follow-up)^a

	N = 1000 Subjects
Pneumothorax
CTCAE Grade 2 or Higher	3.2% (32/1000)
All Grades	4.9% (49/1000)
Bronchopulmonary Hemorrhage
CTCAE Grade 2 and Higher	1.0% (10/1000)
All Grades	2.3% (23/1000)
Respiratory Failure, CTCAE Grade 4 or Higher	0.6% (6/1000)
Death (anesthesia-related respiratory failure 9 days post-ENB)^b	0.1% (1/1000)

Data are presented as % (n/N subjects)
Acronyms: CTCAE Common Terminology Criteria for Adverse Events, ENB electromagnetic navigation bronchoscopy
^aOther than expected observations associated with anesthesia (e.g., common or expected post-procedure pain, transient nausea, transient emesis, post-procedure constipation)
^bGrade 5 hypoxic respiratory failure 9 days after the ENB index procedure, deemed related to complications of general anesthesia, in a patient with multiple comorbidities, including cirrhosis, hepatocellular carcinoma, small cell carcinoma, and ovarian cancer. As of 1-month follow-up, a total of 23 subjects had died (6 completed 1-month follow-up visit; 17 did not). As of the 1-month follow-up, no other deaths were considered related to the ENB device or associated tools by either the clinical investigator or the independent medical monitor

ISSN: 1471-2466