Trial Outcomes & Findings for A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia (NCT NCT02690714)
NCT ID: NCT02690714
Last Updated: 2021-08-02
Results Overview
Overall clinical success was defined as 50% of participants with visible or other measurable lesions achieving at least a 50% improvement in lesion number/size or functionality impact from baseline. Visible lesions were defined as lesions that could be imaged and analyzed with digital photography. Non-visible lesions were defined as lesions whose dimensions could have been assessed by medical imaging studies (eg, computed tomography, magnetic resonance imaging, ultrasound, etc) or functional assessments (eg, spirometry, audiogram, oximetry, etc).Visible lesions that had both a length and width as measured by the 1mm scale, were referred to as "measurable lesions", and visible lesions that were too small to measure by the 1mm scale (length and/or width could not have been measured) were referred to as "non-measurable lesions".
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
15 participants
Primary outcome timeframe
48 weeks
Results posted on
2021-08-02
Participant Flow
This study was conducted at 2 sites, 1 in the United States (US) and 1 in Norway. The first participant was screened in May 2016 and the last participant visit was in October 2018.
Participant milestones
| Measure |
6.6 mg/kg Plasminogen (Human) Intravenous
Prometic Plasminogen (Human) intravenous 6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion for 48 weeks. Some subjects received more than 48 weeks of study drug.
|
|---|---|
|
Segment 1: Single-dose Day -4 to Day 0
STARTED
|
9
|
|
Segment 1: Single-dose Day -4 to Day 0
COMPLETED
|
9
|
|
Segment 1: Single-dose Day -4 to Day 0
NOT COMPLETED
|
0
|
|
Segment 2: Multi-dose Day 0 to Week 12
STARTED
|
15
|
|
Segment 2: Multi-dose Day 0 to Week 12
COMPLETED
|
15
|
|
Segment 2: Multi-dose Day 0 to Week 12
NOT COMPLETED
|
0
|
|
Segment 3: Extended Treatment Wks 12-48
STARTED
|
15
|
|
Segment 3: Extended Treatment Wks 12-48
COMPLETED
|
15
|
|
Segment 3: Extended Treatment Wks 12-48
NOT COMPLETED
|
0
|
|
Post-Wk 48: Safety Week 48 to EoS Visit
STARTED
|
12
|
|
Post-Wk 48: Safety Week 48 to EoS Visit
COMPLETED
|
10
|
|
Post-Wk 48: Safety Week 48 to EoS Visit
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
6.6 mg/kg Plasminogen (Human) Intravenous
Prometic Plasminogen (Human) intravenous 6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion for 48 weeks. Some subjects received more than 48 weeks of study drug.
|
|---|---|
|
Post-Wk 48: Safety Week 48 to EoS Visit
Physician Decision
|
1
|
|
Post-Wk 48: Safety Week 48 to EoS Visit
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
Baseline characteristics by cohort
| Measure |
6.6 mg/kg Plasminogen (Human) Intravenous
n=15 Participants
6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion
Plasminogen (Human) intravenous: Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Age, Continuous
|
23.0 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Age, Customized
2-11 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
12-17 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
> 17 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Latino
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
3 Participants
n=5 Participants
|
|
Weight
|
60.37 Kg
STANDARD_DEVIATION 26.803 • n=5 Participants
|
|
Visible and Non-Visible Lesions by Participant
None
|
4 Participants
n=5 Participants
|
|
Visible and Non-Visible Lesions by Participant
>= 1 Visible or non-visible lesion
|
11 Participants
n=5 Participants
|
|
Number of Visible and Assesable Non-Visible Lesions
Number of lesions analyzed
|
47 Number of lesions
n=5 Participants
|
|
Number of Visible and Assesable Non-Visible Lesions
Visible lesions
|
32 Number of lesions
n=5 Participants
|
|
Number of Visible and Assesable Non-Visible Lesions
Non-visible lesions
|
15 Number of lesions
n=5 Participants
|
|
Plasminogen Activity
|
21.1 % activity
STANDARD_DEVIATION 10.83 • n=5 Participants
|
|
Plasminogen Activity
Plasminogen activity <5-10%
|
3 Participants
n=5 Participants
|
|
Plasminogen Activity
Plasminogen activity 11-20%
|
4 Participants
n=5 Participants
|
|
Plasminogen Activity
Plasminogen activity 21-30%
|
6 Participants
n=5 Participants
|
|
Plasminogen Activity
Plasminogen activity 31-40%
|
1 Participants
n=5 Participants
|
|
Plasminogen Activity
Plasminogen activity 41-45%
|
1 Participants
n=5 Participants
|
|
Plasminogen Activity
Plasminogen activity >45%
|
0 Participants
n=5 Participants
|
|
Plasminogen antigen
|
4.7 mg/dL
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Plasminogen antigen
Plasminogen antigen <0.5-3.0 mg/dL
|
4 Participants
n=5 Participants
|
|
Plasminogen antigen
Plasminogen antigen 3.1-6.0 mg/dL
|
10 Participants
n=5 Participants
|
|
Plasminogen antigen
Plasminogen antigen 6.1-20.0 mg/dL
|
1 Participants
n=5 Participants
|
|
Plasminogen antigen
Plasminogen antigen >20.0 mg/dL
|
0 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 0
|
0 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 1
|
0 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 2
|
0 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 3
|
0 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 4
|
0 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 5
|
0 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 6
|
1 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 7
|
3 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 8
|
1 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 9
|
1 Participants
n=5 Participants
|
|
Quality of Life Assessment
QOL score = 10
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Efficacy Population Week 48-Segment 3 included all 15 enrolled participants who completed the Week 48 visit at the time of the data cut-off date of 14Dec2017. This analysis included 11 participants with 47 visible and/or non-visible lesions at baseline. All 15 participants were assessed, however only 11 participants had visible and/or non-visible lesions at baseline.
Overall clinical success was defined as 50% of participants with visible or other measurable lesions achieving at least a 50% improvement in lesion number/size or functionality impact from baseline. Visible lesions were defined as lesions that could be imaged and analyzed with digital photography. Non-visible lesions were defined as lesions whose dimensions could have been assessed by medical imaging studies (eg, computed tomography, magnetic resonance imaging, ultrasound, etc) or functional assessments (eg, spirometry, audiogram, oximetry, etc).Visible lesions that had both a length and width as measured by the 1mm scale, were referred to as "measurable lesions", and visible lesions that were too small to measure by the 1mm scale (length and/or width could not have been measured) were referred to as "non-measurable lesions".
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=47 Lesions
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 48 Weeks.
Total Visible/Non-Visible lesions resolved (%)
|
34 Lesions
|
|
Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 48 Weeks.
Total Visible/Non-Visible lesions improved (%)
|
10 Lesions
|
|
Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 48 Weeks.
Not applicable (not assessed)
|
3 Lesions
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
Plasminogen activity is a measurement of functional plasminogen levels and is therefore the most accurate and specific method to quantify active Plasminogen (Human) Intravenous concentration in participants' plasma. Primary endpoint success was defined as at least 80% of evaluable participants (ie, 8 or more) achieving the target trough levels for at least 3 measurements in 12 weeks. The target trough level was defined as an increase in plasminogen activity level of at least an absolute 10% (10 U/dL) from the participant's individual baseline level.
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Number and Percentage of Particpants Who Achieved the Target Plasminogen Activity Trough Levels for at Least 3 Measurements in 12 Weeks During Segment 2
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Efficacy population week 12 included all 15 enrolled participants who completed the week 12 visit. All 15 participants were assessed, however only 11 participants had visible and/or non-visible lesions at baseline.
Overall clinical success was defined as 50% of participants with visible or other measurable lesions achieving at least a 50% improvement in lesion number/size or functionality impact from baseline. Visible lesions were defined as lesions that could be imaged and analyzed with digital photography. Non-visible lesions were defined as lesions whose dimensions could have been assessed by medical imaging studies (eg, computed tomography, magnetic resonance imaging, ultrasound, etc) or functional assessments (eg, spirometry, audiogram, oximetry, etc).Visible lesions that had both a length and width as measured by the 1mm scale, were referred to as "measurable lesions", and visible lesions that were too small to measure by the 1mm scale (length and/or width could not have been measured) were referred to as "non-measurable lesions".
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=47 Number of Lesions
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 12 Weeks
Total Visible/Non-Visible lesions resolved
|
26 Number of Lesions
|
|
Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 12 Weeks
Total Visible/Non-Visible lesions improved
|
14 Number of Lesions
|
|
Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 12 Weeks
Total Visible/Non-visible unchanged
|
2 Number of Lesions
|
|
Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 12 Weeks
Not applicable/Not assessed
|
5 Number of Lesions
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: CGI-I population included all 15 enrolled participants who completed the week 12 (and week 48) visit.
CGI-I scores are measured at 12 and 48 weeks after study drug treatment. The CGI-I Scale is a single, clinician completed scale designed to capture the clinician's impression of the participant's disease improvement over time. For this scale, clinicians were asked to consider their experience in this population and rate the change relative to the participant's state at Baseline using a 7-point scale (1 = very much improved, 7 = very much worse).
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
CGI score 0 = Not assessed: Week 12
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
CGI score 1 = Very much improved: Week 12
|
11 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
CGI score 2 = Much improved : Week 12
|
4 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
CGI score 3 = Minimally improved : Week 12
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
CGI score 4= No change : Week 12
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
CGI score 5 = Minimally worse : Week 12
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
CGI score 6 = Much worse : Week 12
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
CGI score 7 = Very much worse : Week 12
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: CGI-I population included all 15 enrolled participants who completed the week 48 (and week 12) visit.
CGI-I scores are measured at 12 and 48 weeks after study drug treatment. The CGI-I Scale is a single, clinician completed scale designed to capture the clinician's impression of the participant's disease improvement over time. For this scale, clinicians were asked to consider their experience in this population and rate the change relative to the participant's state at Baseline using a 7-point scale (1 = very much improved, 7 = very much worse).
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
CGI Score 0= Not assessed: Week 48
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
CGI Score 1= Very much improved: Week 48
|
13 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
CGI Score 2= Much improved: Week 48
|
2 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
CGI Score 3= Minimally improved: Week 48
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
CGI Score 4= No change: Week 48
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
CGI Score 5= Minimally worse: Week 48
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
CGI Score 6= Much worse: Week 48
|
0 Participants
|
|
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
CGI Score 7= Very much worse: Week 48
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Population Week 48-Segment 3 included all 15 enrolled participants who completed the Week 48 visit at the time of the data cut-off date of 14Dec2017
Quality of life score (QOL) was measured at baseline and at 12 and 48 weeks after study drug treatment. For the QOL assessment, participants were asked to rate their overall QOL using an 11-point scale (0 = non-functioning, 10 = normal; The QOL scale was adapted from a scale developed by the American Chronic Pain Association.
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score 0 : Week 12
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 1 : Week 12
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 2 : Week 12
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 3 : Week 12
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 4 : Week 12
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 5 : Week 12
|
1 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 6 : Week 12
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 7 : Week 12
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 8 : Week 12
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 9 : Week 12
|
1 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
QOL score = 10 : Week 12
|
13 Participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Efficacy Population Week 48-Segment 3 included all 15 enrolled participants who completed the Week 48 visit at the time of the data cut-off date of 14Dec2017
Quality of life score (QOL) was measured at baseline and at 12 and 48 weeks after study drug treatment. For the QOL assessment, participants were asked to rate their overall QOL using an 11-point scale (0 = non-functioning, 10 = normal; The QOL scale was adapted from a scale developed by the American Chronic Pain Association.
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 0: Week 48
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 1: Week 48
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 2: Week 48
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 3: Week 48
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 4: Week 48
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 5: Week 48
|
1 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 6: Week 48
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 7: Week 48
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 8: Week 48
|
0 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 9: Week 48
|
1 Participants
|
|
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
QOL Score 10: Week 48
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 120Population: Pharmacokinetic Population included any participant who had completed Segment 2, 3 and post week 48 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
Plasminogen activity trough levels were measured at Weeks 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 2
|
45.1 percentage of activity
Standard Deviation 15.05
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 4
|
48.9 percentage of activity
Standard Deviation 14.56
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 6
|
52.4 percentage of activity
Standard Deviation 11.45
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 8
|
48.3 percentage of activity
Standard Deviation 17.43
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 10
|
50.2 percentage of activity
Standard Deviation 12.39
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 12
|
51.0 percentage of activity
Standard Deviation 12.01
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 24
|
45.0 percentage of activity
Standard Deviation 12.88
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 36
|
45.5 percentage of activity
Standard Deviation 13.18
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 48
|
41.7 percentage of activity
Standard Deviation 16.99
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 60
|
49.0 percentage of activity
Standard Deviation 8.88
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 72
|
46.7 percentage of activity
Standard Deviation 10.97
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 84
|
51.7 percentage of activity
Standard Deviation 20.76
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 96
|
50.1 percentage of activity
Standard Deviation 20.08
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 108
|
45.0 percentage of activity
Standard Deviation 25.19
|
|
Plasminogen Activity Trough Levels Between Week 2 and Week 120
Week 120
|
36.5 percentage of activity
Standard Deviation 12.02
|
SECONDARY outcome
Timeframe: Week 2 to Week 120Population: Pharmacokinetic Population included any participant who had completed Segment 2, 3 and post week 48 dosing and had provided at least 3 blood samples to measure plasminogen antigen trough levels.
Plasminogen antigen trough levels were measured at Weeks 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 2
|
6.550 mg/dL
Standard Deviation 3.0457
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 4
|
7.800 mg/dL
Standard Deviation 3.8813
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 6
|
7.268 mg/dL
Standard Deviation 3.3155
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 8
|
6.607 mg/dL
Standard Deviation 3.0046
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 10
|
9.460 mg/dL
Standard Deviation 7.1543
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 12
|
7.340 mg/dL
Standard Deviation 2.9342
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 24
|
5.913 mg/dL
Standard Deviation 2.2181
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 36
|
6.667 mg/dL
Standard Deviation 2.7336
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 48
|
6.973 mg/dL
Standard Deviation 3.1299
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 60
|
6.415 mg/dL
Standard Deviation 1.7578
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 72
|
6.083 mg/dL
Standard Deviation 2.2851
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 84
|
7.183 mg/dL
Standard Deviation 3.8129
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 96
|
7.656 mg/dL
Standard Deviation 4.2030
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 108
|
6.529 mg/dL
Standard Deviation 4.0852
|
|
Plasminogen Antigen Trough Levels Between Week 2 and Week 120
Week 120
|
6.550 mg/dL
Standard Deviation 6.2933
|
SECONDARY outcome
Timeframe: First dose and 12 weeksPopulation: Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
t1/2 is time required for the plasma concentration of Plasminogen to decrease 50% in the final stage of its elimination
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Half-life (t1/2) of Plasminogen Activity After First Dose and at Week 12
Mean (SD) t1/2 of plasminogen after the first dose
|
34 Hours
Standard Deviation 11.73
|
|
Half-life (t1/2) of Plasminogen Activity After First Dose and at Week 12
Mean (SD) t1/2 of plasminogen at week 12
|
39.2 Hours
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: First dose and 12 weeksPopulation: Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
AUCLast is the area under the plasma concentration-curve of Plasminogen from time 0 to the last measured concentration.
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
AUClast of Plasminogen Activity After the First Dose and at Week 12
Mean (SD) AUClast after first dose of plasminogen
|
3063.6 hr*%
Standard Deviation 778.67
|
|
AUClast of Plasminogen Activity After the First Dose and at Week 12
Mean (SD) AUClast at Week 12
|
4656.0 hr*%
Standard Deviation 1012.66
|
SECONDARY outcome
Timeframe: First dose and 12 weeksPopulation: Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
Cmax is the maximum plasma concentration of Plasminogen
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Cmax of Plasminogen Activity After First Dose and at Week 12
Mean (SD) Cmax of plasminogen after first dose
|
95 % plasminogen activity
Standard Deviation 23.5
|
|
Cmax of Plasminogen Activity After First Dose and at Week 12
Mean (SD) Cmax of plasminogen at Week 12
|
125 % plasminogen activity
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: First dose and 12 weeksPopulation: Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
Cl is the volume of plasma cleared of Plasminogen per unit time
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Cl of Plasminogen Activity After First Dose and at Week 12
Mean (SD) Cl of plasminogen after first dose
|
1.44 mL/hr/kg
Standard Deviation 0.460
|
|
Cl of Plasminogen Activity After First Dose and at Week 12
Mean (SD) Cl of plasminogen at Week 12
|
0.92 mL/hr/kg
Standard Deviation 0.257
|
SECONDARY outcome
Timeframe: First dose and 12 weeksPopulation: Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
AUCinf is the area under the plasma concentration-curve of Plasminogen from time 0 extrapolated to infinity
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
AUCinf of Plasminogen Activity After First Dose and at Week 12
Mean (SD) AUCinf of plasminogen after first dose
|
3605.8 hr*%
Standard Deviation 1023.88
|
|
AUCinf of Plasminogen Activity After First Dose and at Week 12
Mean (SD) AUCinf of plasminogen at Week 12
|
5731.8 hr*%
Standard Deviation 1431.70
|
SECONDARY outcome
Timeframe: First dose and 12 weeksPopulation: Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
MRTLast is the mean residence time of Plasminogen from time 0 to the last measured concentration
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
MRTlast for Plasminogen Activity After First Dose and at Week 12
Mean (SD) MRTlast of plasminogen after first dose
|
30.6 hours
Standard Deviation 3.22
|
|
MRTlast for Plasminogen Activity After First Dose and at Week 12
Mean (SD) MRTlast of plasminogen at Week 12
|
33.5 hours
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: First dose and 12 weeksPopulation: Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels.
Vss is the apparent volume of distribution at steady state of Plasminogen
Outcome measures
| Measure |
Plasminogen (Human) Intravenous
n=15 Participants
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Vss for Plasminogen Activity After First Dose and at Week 12
Mean (SD) Vss of plasminogen after first dose
|
63.3 mL/kg
Standard Deviation 11.44
|
|
Vss for Plasminogen Activity After First Dose and at Week 12
Mean (SD) Vss of plasminogen at Week 12
|
49.3 mL/kg
Standard Deviation 10.36
|
Adverse Events
6.6 mg/kg Plasminogen (Human) Intravenous
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
6.6 mg/kg Plasminogen (Human) Intravenous
n=15 participants at risk
6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion for 48 weeks (Norway) and longer until product licensing or study termination by the Sponsor (US).
Plasminogen (Human) intravenous: Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Surgical and medical procedures
Ear operation
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Surgical and medical procedures
Ossiculoplasty
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
Other adverse events
| Measure |
6.6 mg/kg Plasminogen (Human) Intravenous
n=15 participants at risk
6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion for 48 weeks (Norway) and longer until product licensing or study termination by the Sponsor (US).
Plasminogen (Human) intravenous: Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
|
|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Cardiac disorders
Cardiac flutter
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Congenital, familial and genetic disorders
Ehlers-Danlos syndrome
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Ear and labyrinth disorders
Motion sickness
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Eye disorders
Conjunctival deposit
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Eye disorders
Eye discharge
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Eye disorders
Eye inflammation
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Eye disorders
Eye irritation
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Eye disorders
Eye pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Eye disorders
Eye swelling
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Eye disorders
Ocular hyperaemia
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
5/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
40.0%
6/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Dental carries
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.7%
7/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
3/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Gastric dilatation
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Tooth development disorder
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Asthenia
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Chest discomfort
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Chills
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Fatigue
|
20.0%
3/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Feeling abnormal
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Influenza like illness
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Infusion site bruising
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Infusion site discomfort
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Infusion site erythema †
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Infusion site extravasation
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Infusion site pain
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Infusion site rash
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Infusion site swelling
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Peripheral swelling
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
General disorders
Pyrexia
|
40.0%
6/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Immune system disorders
Seasonal allergies
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Conjunctivitis
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Cystitis
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Ear infection
|
20.0%
3/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Fungal infection
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
H1N1 influenza
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Hordeolum
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Influenza
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Nasopharyngitis
|
66.7%
10/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
20.0%
3/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Sinusitis
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Tonsilitis
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Tooth infection
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
3/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Chest injury
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Scratch
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Investigations
Blood iron decrease
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Investigations
Blood pressure systolic increased
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Investigations
Progesterone decreased
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Nervous system disorders
Burning sensation
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Nervous system disorders
Dizziness
|
20.0%
3/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Nervous system disorders
Headache
|
53.3%
8/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Nervous system disorders
Migraine
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Nervous system disorders
Post-traumatic headache
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Psychiatric disorders
Mood altered
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Psychiatric disorders
Panic attack
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Psychiatric disorders
Restlessness
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Renal and urinary disorders
Dysuria
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Renal and urinary disorders
Renal pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Reproductive system and breast disorders
Ovulation pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Reproductive system and breast disorders
Uterine pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.7%
7/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic disorder
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropahryngeal discomfort
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
53.3%
8/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
40.0%
6/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
3/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
4/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Tumour pruritis
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Surgical and medical procedures
Artificial crown procedure
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Surgical and medical procedures
Central venous catheter removal
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Surgical and medical procedures
Tooth repair
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Surgical and medical procedures
Venipuncture
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Vascular disorders
Haemorrhage
|
13.3%
2/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Vascular disorders
Dystension
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
6.7%
1/15 • Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug treatment.
|
Additional Information
Senior Director, Clinical Development
Prometic Biotherapeutics Inc.
Phone: 301-549-9761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of data generated in the study is governed by the Investigator Clinical Trial Agreement
- Publication restrictions are in place
Restriction type: OTHER