2. Grade 3 or 4 toxicity judged to be possibly or probably related to study 
therapy, or the development of other unexpected, life-threatening complication not 
described. 
3. Patient noncompliance with study therapy and/or clinic appointments. 
4. Voluntary withdrawal; a patient may remove himself/herself from the study at 
any time without prejudice. 
5. Termination of the study by the principal investigator, the sponsor, or the 
Food and Drug Administration. 
8.0 PATIENT EVALUATION 
8.1 Schedule of evaluations 
Inpatient Schedule 
Day 
-4 
0 
1 
3 
10 
14 
History 
* 
Physical Exam 
* 
* 
* 
* 
* 
* 
Nasal Brushing 
* 
* 
* 
* 
BAL 
* 
* 
* 
Nasal TEPD 
* 
* 
* 
* 
Chest CT and X-ray 
* 
PFTs 
* 
* 
* 
* 
* 
* 
CBC, Coag, Chem 
* 
* 
* 
* 
* 
Viral Cx (4 sites) 
* 
* 
Admission 
* 
Vehicle Instillation 
* 
Vector Instillation 
* 
Discharge 
* 
Outpatient Schedule 
Day 
30 
60 
90 
180 
270 
365 
History 
* 
* 
* 
* 
* 
* 
Physical Exam 
* 
* 
* 
* 
* 
* 
Nasal Brushing 
* 
* 
* 
* 
* 
* 
BAL 
* 
* 
* 
* 
* 
* 
Nasal TEPD 
* 
* 
* 
* 
* 
* 
Chest CT and X-ray 
* 
* 
PFTs 
* 
* 
* 
* 
* 
* 
CBC, Coag, Chem 
* 
* 
* 
* 
* 
[126] 
Recombinant DNA Research, Volume 20 
