9.2 Risks Associated with the Study Procedures 
9.2.1 Bronchoscopy 
Bronchoscopy and intravenous sedation in patients with a history of lung disease carries 
the risk of hypoventilation or bronchospasm. Bronchoscopy will be carried out in the 
presence of a study doctor and anesthesiologist in a procedures room equipped for 
ventilatory assistance. Patients will be monitored for oxygen saturation prior to, during, 
and following bronchoscopy. Supplemental oxygen, bronchodilators, or other respiratory 
support will be provided as needed. Other complications that could occur include 
nosebleeds, fever, hypotension, or hemoptysis. 
9.2.2 Risks Judged To Be Minor 
Nasal brushing can produce mild discomfort or nosebleeds. Bleeding, bruising, and pain 
are well known risks from venipuncture. Chest X-rays and CT scans give rise to risk from 
radiation exposure. Three chest X-rays and 3 CT scans are expected during the course of 
the study. This radiation dose is equivalent to 1.1 rems to the whole body. This dose is not 
thought to be harmful, although the long term risks from very low doses of ionizing 
radiation are unknown. 
9.3 Potential Benefits 
This study is unlikely to directly benefit any patient. Transfer of the AAV-CFTR vector will 
be limited to the nasal mucosa and a single lung lobe; this limited application will almost 
certainly have no long term clinical benefit to the patient. This study is designed to evaluate 
the safety and activity of the AAV-CFTR vector; this information will help guide future 
studies that could result in therapeutic benefit to patients with cystic fibrosis. 
10.0 ADVERSE EVENT REPORTING 
Long-term follow-up after completion of the study will be done with the referring physician 
on a yearly basis for the remainder of the patient's life. 
10.1 Serious Adverse Events 
Serious adverse events occurring during or after completion of therapy are defined as any 
one of the following: 
1 . Patient death, regardless of cause, occurring within 90 days of study agent 
administration 
2. Life-threatening event 
3. Prolonged hospitalization or requirement for additional hospitalizations during 
the treatment and monitoring period 
4. Congenital anomaly in offspring conceived after initiation of the study 
5. Persistent or significant disability or incapacity 
6. Cancer 
7. Required significant medical treatment 
8. Overdose of study agent 
A life-threatening event is defined as the patient, in the view of the Investigator, having 
been at immediate risk of death from the reaction as it occurred. It does not include a 
reaction that, had it occurred in a more serious form, might have caused death. 
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