Trial Outcomes & Findings for Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin (AAT) Deficiency (NCT NCT00430768)
NCT ID: NCT00430768
Last Updated: 2016-12-15
Results Overview
Adverse events considered possibly, probably or definitely related to study drug/study drug procedure Criteria to evaluate severity according to Attachment 2 of the Protocol 1. Mild toxicity, usually transient, requiring no special treatment and generally not interfering with usual daily activities 2. Moderate toxicity which may be ameliorated by simple therapeutic maneuvers, and impairs usual activities 3. Severe toxicity which requires therapeutic intervention and interrupts usual activities. Hospitalization may or may not be required 4. Life-threatening toxicity which requires hospitalization
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
During 1 year after study agent administration
Results posted on
2016-12-15
Participant Flow
Subjects were recruited to the University of Florida, Clinical Research Center for the active study; long term follow up was completed at the University of Massachusetts, Medical School.
Subjects on alpha-1 antitrypsin (AAT) protein replacement product prior to study, discontinued treatment 4 weeks (Group 1) and 8 weeks (Groups 2 and 3) prior to study agent administration and were able to resume treatment 11 weeks after study agent had been administered. The group was determined by when the subject joined the study.
Participant milestones
| Measure |
Group 1 Low Dose
6.9 x10e12 vector genomes (vg)
Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg.
|
Group 2 Middle Dose
2.1 x 10e13 vector genomes; 2.2 x 10e13 vector genomes
Group 2, 1 subject received rAAV1-CB-hAAT 2.1 x10e13 vg; 202 and 203 received rAAV1-CB-hAAT 2.2 x10e13 vg
|
Group 3 High Dose
rAAV1-CB-hAAT 6.0 x10e13 vg
Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin (AAT) Deficiency
Baseline characteristics by cohort
| Measure |
Group 1 Low Dose
n=3 Participants
6.9 x10e12 vector genomes
Group 1 receives rAAV1-CB-hAAT 6.9 x1012 vg (vector genomes), e
|
Group 2 Middle Dose
n=3 Participants
2.1 x 10e13 vector genomes
Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg
|
Group 3 High Dose
n=3 Participants
rAAV1-CB-hAAT 6.0 x10e13 vg
Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
69 years
n=5 Participants
|
54 years
n=7 Participants
|
47 years
n=5 Participants
|
54 years
n=4 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Gender
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
FEV1 (% predicted)
|
86.7 percent predicted
n=5 Participants
|
50.8 percent predicted
n=7 Participants
|
58.0 percent predicted
n=5 Participants
|
58.0 percent predicted
n=4 Participants
|
|
Weight (kg)
|
66.5 kilograms
n=5 Participants
|
83.0 kilograms
n=7 Participants
|
72.6 kilograms
n=5 Participants
|
72.6 kilograms
n=4 Participants
|
|
Prior AAT Protein Augmentation Therapy
Yes
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Prior AAT Protein Augmentation Therapy
No
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During 1 year after study agent administrationPopulation: subjects in the group reporting the event
Adverse events considered possibly, probably or definitely related to study drug/study drug procedure Criteria to evaluate severity according to Attachment 2 of the Protocol 1. Mild toxicity, usually transient, requiring no special treatment and generally not interfering with usual daily activities 2. Moderate toxicity which may be ameliorated by simple therapeutic maneuvers, and impairs usual activities 3. Severe toxicity which requires therapeutic intervention and interrupts usual activities. Hospitalization may or may not be required 4. Life-threatening toxicity which requires hospitalization
Outcome measures
| Measure |
Group 1 Low Dose
n=3 Participants
|
Group 2 Middle Dose
n=3 Participants
|
Group 3 High Dose
n=3 Participants
|
301 (High Dose)
Subject 301M-specific AAT Level
|
302 (High Dose)
Subject 302 M-specific AAT Level
|
303 (High Dose)
Subject 303 M-specific AAT Level
|
|---|---|---|---|---|---|---|
|
Adverse Events Possibly, Probably or Definitely Related to Study Drug
Inject site swelling mild
|
1 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Drug
Injection site warmth
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Drug
Number with one or more related AE
|
2 participants
|
2 participants
|
3 participants
|
—
|
—
|
—
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Drug
injection site erythema mild
|
2 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Drug
Inject site hematoma mild
|
1 participants
|
2 participants
|
3 participants
|
—
|
—
|
—
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Drug
Inject site induration mild
|
1 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Drug
Inject site pain mild
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 14, 30, 45, 60, 90, (180, 270, and 365 if not on protein replacement therapy)Population: AAT Levels of each subject at various time points Baseline and Days following administration. 202 Day 365 blood hemolyzed; not determinable, 201 and 303 went back on AAT protein augmentation therapy after day 90, unable to collect M-specific levels on day 180, 270 and 303.
4 subjects received prior AAT augmentation therapy; 2 subjects from Group 1 having only washed out for only 28 days complicated the measurement of M-specific levels 2 subjects from group 1 and the other subject did not have an appreciable change in M-specific AAT levels. Thus reporting only Cohorts 2 and 3. After day 90 patients were able to resume AAT protein therapy and thus levels were not collected following commencement of therapy on 201 and 303. 202, Day 365 blood hemolyzed; level not determinable.
Outcome measures
| Measure |
Group 1 Low Dose
n=1 Participants
|
Group 2 Middle Dose
n=1 Participants
|
Group 3 High Dose
n=1 Participants
|
301 (High Dose)
n=1 Participants
Subject 301M-specific AAT Level
|
302 (High Dose)
n=1 Participants
Subject 302 M-specific AAT Level
|
303 (High Dose)
n=1 Participants
Subject 303 M-specific AAT Level
|
|---|---|---|---|---|---|---|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Baseline Level
|
33 nM
|
10.8 nM
|
11.2 nM
|
9.6 nM
|
7.1 nM
|
18.3 nM
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 14 Level
|
7.5 nM
|
12.7 nM
|
12.0 nM
|
13.2 nM
|
10.3 nM
|
7.8 nM
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 30 Level
|
7.5 nM
|
17.8 nM
|
14.7 nM
|
24.7 nM
|
16.6 nM
|
10.5 nM
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 45 Level
|
6.2 nM
|
16.7 nM
|
14.5 nM
|
22.6 nM
|
18.5 nM
|
41.5 nM
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 60 Level
|
15.1 nM
|
16.8 nM
|
20.7 nM
|
20.8 nM
|
10.5 nM
|
37.7 nM
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 75 Level
|
14.6 nM
|
14.7 nM
|
12.9 nM
|
21.8 nM
|
14.3 nM
|
45.9 nM
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 90 Level
|
26.8 nM
|
12.6 nM
|
14.6 nM
|
42.6 nM
|
6.7 nM
|
48.5 nM
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 180 Level
|
NA nM
resumed AAT protein therapy
|
9.8 nM
|
10.8 nM
|
41.7 nM
|
26.4 nM
|
NA nM
resumed AAT protein therapy
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 270 Level
|
NA nM
resumed AAT protein therapy
|
8.0 nM
|
7.0 nM
|
47.9 nM
|
33.5 nM
|
NA nM
resumed AAT protein therapy
|
|
hAAT Expression in Blood Measured Using M-specific Allele ELISA
Day 365 Level
|
NA nM
resumed AAT protein therapy
|
NA nM
blood hemolyzed
|
24.2 nM
|
50.9 nM
|
33.4 nM
|
NA nM
resumed AAT protein therapy
|
Adverse Events
Group 1 Low Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2 Middle Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 3 High Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 Low Dose
n=3 participants at risk
6.9 x10e12 vector genomes
e. Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg (vector genomes)
|
Group 2 Middle Dose
n=3 participants at risk
2.2 x 10e13 vector genomes
Group 2 receives rAAV1-CB-hAAT 2.1 x10e13 vg
|
Group 3 High Dose
n=3 participants at risk
rAAV1-CB-hAAT 6.0 x10e13 vg
Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg
|
|---|---|---|---|
|
Reproductive system and breast disorders
E. coli Epididymitis
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Gastrointestinal disorders
Pharyngoesophageal diverticulum repair with complications
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
Other adverse events
| Measure |
Group 1 Low Dose
n=3 participants at risk
6.9 x10e12 vector genomes
e. Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg (vector genomes)
|
Group 2 Middle Dose
n=3 participants at risk
2.2 x 10e13 vector genomes
Group 2 receives rAAV1-CB-hAAT 2.1 x10e13 vg
|
Group 3 High Dose
n=3 participants at risk
rAAV1-CB-hAAT 6.0 x10e13 vg
Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg
|
|---|---|---|---|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
General disorders
Injection site erythema
|
66.7%
2/3 • Number of events 2 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
General disorders
Injection site hematoma
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
66.7%
2/3 • Number of events 2 • 1 year active study; 4 years long term follow up
|
100.0%
3/3 • Number of events 3 • 1 year active study; 4 years long term follow up
|
|
General disorders
Injection site induration
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
General disorders
Injection site pain
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
General disorders
Injection site swelling
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
General disorders
Injection site warmth
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Escherichia urinary tract infection
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Oral candidiasis
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Tooth infection
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
66.7%
2/3 • Number of events 2 • 1 year active study; 4 years long term follow up
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Investigations
Blood cholesterol increased
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Investigations
Gamma-glutamyl transferase increased
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Nervous system disorders
headache
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Psychiatric disorders
depression
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
66.7%
2/3 • Number of events 2 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Sinus headache
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Gastrointestinal disorders
Pharyngoesophageal diverticulum
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Reproductive system and breast disorders
Prostate Cancer
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
|
Skin and subcutaneous tissue disorders
Subcutaneous abscess
|
33.3%
1/3 • Number of events 1 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
0.00%
0/3 • 1 year active study; 4 years long term follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60