Trial Outcomes & Findings for Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B (NCT NCT02396342)
NCT ID: NCT02396342
Last Updated: 2022-06-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From AMT-060 infusion through end of study (5 years post-dose)
Results posted on
2022-06-27
Participant Flow
Patients with congenital haemophilia B. Known severe FIX deficiency with plasma FIX activity level \< 1% and a severe bleeding phenotype. Known moderately severe FIX deficiency with plasma FIX activity level between ≥ 1% and ≤ 2% and a severe bleeding phenotype. More than 150 previous exposure days of treatment with FIX protein
Participant milestones
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B
Baseline characteristics by cohort
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From AMT-060 infusion through end of study (5 years post-dose)Population: Full Analysis Set (FAS) which was comprised of all dosed subjects
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Number of Participants With Adverse Events
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through end of study (5 years post-dose)Population: FAS. Only assessments performed more than 10 days after most recent FIX-replacement therapy administration included.
FIX activity measured any time from 72 hours after latest FIX replacement therapy administration and until next administration of FIX replacement therapy. Only assessments performed more than 10 days after most recent FIX-replacement therapy administration included.
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=4 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
FIX-replacement-therapy-free FIX Activity
one-stage aPTT assay
|
7.43 Percent FIX activity
Standard Deviation 1.28
|
6.60 Percent FIX activity
Standard Deviation 1.96
|
|
FIX-replacement-therapy-free FIX Activity
amidolytic/chromogenic assay
|
4.58 Percent FIX activity
Standard Deviation 2.88
|
4.74 Percent FIX activity
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through end of study (5 years post-dose)Population: FAS. One subject in Cohort 2 did not report any bleeding information for the period 1 year prior to screening. Post-tapering period = from discontinuation of FIX prophylaxis until data cutoff.
Annualized: Sum of post-treatment bleeding episodes divided by subjects' average number of years (365.25 days) from treatment start to until the data cutoff date.
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Total Annualized Bleeding Rate (ABR)
One Year Prior to Screening
|
14.40 bleeds/year/subject
Standard Deviation 5.73
|
4.00 bleeds/year/subject
Standard Deviation 3.16
|
|
Total Annualized Bleeding Rate (ABR)
Post-tapering Period
|
5.39 bleeds/year/subject
Standard Deviation 5.94
|
0.71 bleeds/year/subject
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through end of study (5 years post dose).Population: FAS. Post-tapering period = from discontinuation of FIX prophylaxis until data cutoff.
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Total Consumption of FIX Replacement Therapy
One year prior to screening
|
326532 IU
Standard Deviation 234900
|
233778 IU
Standard Deviation 156873
|
|
Total Consumption of FIX Replacement Therapy
Post-tapering period
|
252950 IU
Standard Deviation 222790
|
85800 IU
Standard Deviation 84482
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through the end of study (5 years post dose)Population: FAS
Scores range from 0 to 100, with a higher score defining a more favorable health state.
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
Physical Functioning
|
0.00 score on a scale
Standard Deviation 10.00
|
-7.00 score on a scale
Standard Deviation 9.75
|
|
Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
Role-Physical
|
-15.00 score on a scale
Standard Deviation 8.39
|
-10.00 score on a scale
Standard Deviation 22.79
|
|
Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
Bodily Pain
|
-9.00 score on a scale
Standard Deviation 9.00
|
1.20 score on a scale
Standard Deviation 14.81
|
|
Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
General Health
|
-0.80 score on a scale
Standard Deviation 20.22
|
-2.40 score on a scale
Standard Deviation 8.99
|
|
Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
Vitality
|
-11.25 score on a scale
Standard Deviation 19.96
|
-6.25 score on a scale
Standard Deviation 12.50
|
|
Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
Social Functioning
|
-20.00 score on a scale
Standard Deviation 25.92
|
-5.00 score on a scale
Standard Deviation 14.25
|
|
Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
Role-Emotional
|
-13.33 score on a scale
Standard Deviation 27.39
|
-10.00 score on a scale
Standard Deviation 13.69
|
|
Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
Mental Health
|
-13.00 score on a scale
Standard Deviation 22.80
|
-9.00 score on a scale
Standard Deviation 12.94
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through end of study (5 years post dose).Population: FAS. Subject in Cohort 1 was unable to produce semen due to a historical medical condition.
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Time to Vector DNA Stopped Shedding From Blood, Nasal Secretions, Saliva, Urine, Feces, and Semen
Blood
|
508.8 Days
Standard Deviation 261.7
|
705.4 Days
Standard Deviation 245.1
|
|
Time to Vector DNA Stopped Shedding From Blood, Nasal Secretions, Saliva, Urine, Feces, and Semen
Nasal secretions
|
83.4 Days
Standard Deviation 41.7
|
108.4 Days
Standard Deviation 66.0
|
|
Time to Vector DNA Stopped Shedding From Blood, Nasal Secretions, Saliva, Urine, Feces, and Semen
Saliva
|
75.8 Days
Standard Deviation 38.4
|
129.2 Days
Standard Deviation 48.9
|
|
Time to Vector DNA Stopped Shedding From Blood, Nasal Secretions, Saliva, Urine, Feces, and Semen
Urine
|
46.4 Days
Standard Deviation 20.9
|
82.0 Days
Standard Deviation 41.1
|
|
Time to Vector DNA Stopped Shedding From Blood, Nasal Secretions, Saliva, Urine, Feces, and Semen
Feces
|
74.0 Days
Standard Deviation 25.7
|
165.0 Days
Standard Deviation 68.9
|
|
Time to Vector DNA Stopped Shedding From Blood, Nasal Secretions, Saliva, Urine, Feces, and Semen
Semen
|
227.8 Days
Standard Deviation 147.7
|
157.2 Days
Standard Deviation 78.4
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through end of study (5 years post dose)Population: FAS
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Number of Subjects Developing Neutralizing Antibodies to AAV5
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: AMT-060 infusion through end of study (5 years post dose)Population: FAS
For subjects with a titer of 109350 and 50, the actual titer is \>109350 and \<50.
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Total IgG and IgM Antibody Titers to AAV5
IgG (subject 1)
|
79499 Titer
|
109350 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgG (subject 2)
|
109350 Titer
|
109350 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgG (subject 3)
|
109350 Titer
|
109350 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgG (subject 4)
|
109350 Titer
|
107344 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgG (subject 5)
|
109350 Titer
|
109350 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgM (subject 1)
|
56 Titer
|
30071 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgM (subject 2)
|
1321 Titer
|
20000 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgM (subject 3)
|
557 Titer
|
6649 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgM (subject 4)
|
11568 Titer
|
50 Titer
|
|
Total IgG and IgM Antibody Titers to AAV5
IgM (subject 5)
|
809 Titer
|
50 Titer
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through 26 weeks post-dosePopulation: FAS
Specific AAV5 response (results \>17 SFC/million PBMCs) were regarded as positive.
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Number of Subjects With a Positive AAV5 Capsid-specific T Cell Response
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through the end of study (5 years post dose)Population: FAS
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Number of Subjects With Antibodies to FIX
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through the end of study (5 years post dose)Population: FAS
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Number of Subjects With FIX Inhibitors
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From AMT-060 infusion through 18 weeks post dosePopulation: FAS
Outcome measures
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 Participants
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 Participants
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Number of Subjects With Clinically Significant Inflammatory Markers: IL-1β, IL-2, IL-6, INFγ, MCP-1
|
0 participants
|
0 participants
|
Adverse Events
AAV5-hFIX Low Dose (Cohort 1)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
AAV5-hFIX High Dose (Cohort 2)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 participants at risk
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 participants at risk
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Investigations
Hepatic Enzyme Increased
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Renal and urinary disorders
Renal Colic
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Renal and urinary disorders
Calculus Ureteric
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
Other adverse events
| Measure |
AAV5-hFIX Low Dose (Cohort 1)
n=5 participants at risk
AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
AAV5-hFIX High Dose (Cohort 2)
n=5 participants at risk
AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion
AAV5-hFIX: AAV5hFIX gene therapy
|
|---|---|---|
|
Vascular disorders
Haematoma
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Immune system disorders
Hypersensitivity
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
40.0%
2/5 • Number of events 2 • 5 years post-dose
|
|
General disorders
Influenza like illness
|
60.0%
3/5 • Number of events 3 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
|
General disorders
Malaise
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
General disorders
Drug ineffective
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Psychiatric disorders
Sleep disorder
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Bone contusion
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Injury
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Muscle strain
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Investigations
Haemoglobin decreased
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Investigations
Transaminases increased
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Investigations
Blood urine present
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Number of events 2 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Eye disorders
Blepharitis
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Eye disorders
Cataract
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Ear and labyrinth disorders
Vertigo positional
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Food poisoning
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Abdominal pain lower
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Gastrointestinal disorders
Large intestine polyp
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Renal and urinary disorders
Renal colic
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Renal and urinary disorders
Nephrolithiasis
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Skin and subcutaneous tissue disorders
Eczema
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
40.0%
2/5 • Number of events 3 • 5 years post-dose
|
40.0%
2/5 • Number of events 2 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
60.0%
3/5 • Number of events 10 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
20.0%
1/5 • Number of events 3 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
40.0%
2/5 • Number of events 4 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
60.0%
3/5 • Number of events 8 • 5 years post-dose
|
|
Infections and infestations
Influenza
|
40.0%
2/5 • Number of events 2 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Eye infection
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 2 • 5 years post-dose
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Infections and infestations
Rhinitis
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Cystitis
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Infections and infestations
Oral herpes
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Laryngitis
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Infections and infestations
Herpes zoster
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Respiratory tract infection
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
0.00%
0/5 • 5 years post-dose
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
|
Infections and infestations
Ear infection
|
0.00%
0/5 • 5 years post-dose
|
20.0%
1/5 • Number of events 1 • 5 years post-dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place