Trial Outcomes & Findings for A Factor IX Gene Therapy Study (FIX-GT) (NCT NCT03369444)
NCT ID: NCT03369444
Last Updated: 2022-12-02
Results Overview
Safety as assessed by the reporting of AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From Day 0 (first dose of FLT180a) until week 26 post infusion (up to 26 weeks)
Results posted on
2022-12-02
Participant Flow
All patients enrolled were dosed. There are no significant events in the study that occur between enrolment and dosing.
Participant milestones
| Measure |
FLT180a First Dose
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Factor IX Gene Therapy Study (FIX-GT)
Baseline characteristics by cohort
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e11 vg/kg solution for infusion
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Between 18 and 67 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Body Mass Index
|
21.3 kg/m2
n=5 Participants
|
29.55 kg/m2
n=7 Participants
|
24.75 kg/m2
n=5 Participants
|
28.75 kg/m2
n=4 Participants
|
26.62 kg/m2
n=21 Participants
|
PRIMARY outcome
Timeframe: From Day 0 (first dose of FLT180a) until week 26 post infusion (up to 26 weeks)Population: All treated patients.
Safety as assessed by the reporting of AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Outcome measures
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Frequency and Severity of Treatment-emergent Adverse Events (TEAEs) (Safety)
Number of TEAEs
|
11 Events
|
37 Events
|
25 Events
|
108 Events
|
|
Frequency and Severity of Treatment-emergent Adverse Events (TEAEs) (Safety)
Serious TEAEs
|
0 Events
|
6 Events
|
4 Events
|
5 Events
|
|
Frequency and Severity of Treatment-emergent Adverse Events (TEAEs) (Safety)
FLT180a-related TEAEs
|
0 Events
|
13 Events
|
4 Events
|
10 Events
|
|
Frequency and Severity of Treatment-emergent Adverse Events (TEAEs) (Safety)
Serious FLT180a-related TEAEs
|
0 Events
|
3 Events
|
4 Events
|
4 Events
|
PRIMARY outcome
Timeframe: From screening until week 26 post infusion (Up to 38 weeks)Population: Patients treated at the terminal dose (1.3x10e12 vg/kg)
The proportion of participants at the terminal dose (1.3 x 10e\^12 vg/kg) achieving clinical FIX response and proportion of patients achieving normalised FIX response at Week 26. A clinical FIX response is defined as achieving a FIX activity of 5% to 150%. Normalised FIX response is defined as achieving FIX activity in the normal range (50-150%).
Outcome measures
| Measure |
FLT180a First Dose
n=4 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Number of Participants With FIX Activity Response
Clinical FIX Responders (≥5% and ≤150% of Normal)
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With FIX Activity Response
Normalised FIX Responders (≥50% and ≤150% of Normal)
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening until week 26 post infusion (Up to 38 weeks)Population: Safety as assessed by reporting of abnormal or change from baseline findings from safety assessments including, laboratory assessments, vital signs, ECG, physical exam and liver ultrasound.
Safety as assessed by reporting of abnormal or change from baseline findings from routine safety assessments including, laboratory assessments, ECG, physical exam and liver ultrasound.
Outcome measures
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Albumin (g/L)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 8 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 9 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 10 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 11 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 2 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 3 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Haemoglobin
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
2 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Leukocytes (10e9/L0
|
1 Number of participants
|
0 Number of participants
|
2 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Lymphocytes count decreased (10e9/L)
|
1 Number of participants
|
2 Number of participants
|
2 Number of participants
|
3 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Lymphocytes count increased (10e9/L)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Neutrophils (10e9/L)
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Platelets (10e9/L)
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Basophils (10e9/L)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Eosinophils (10e9/L)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Erythrocytes (10e12/L)
|
1 Number of participants
|
2 Number of participants
|
2 Number of participants
|
2 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
C Reactive Protein (mg/L)
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
4 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Chloride (mmol/L)
|
2 Number of participants
|
2 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Direct Bilirubin (umol/L)
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Indirect Billirubin (umol/L)
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Phosphate (mmol/L)
|
2 Number of participants
|
1 Number of participants
|
1 Number of participants
|
4 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Protein (g/L)
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
3 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Hemotocrit (L/L)
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Monocytes (10e9/L)
|
1 Number of participants
|
2 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Thrombin/Antithrombin (ug/L)
|
2 Number of participants
|
2 Number of participants
|
2 Number of participants
|
4 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Alanine Aminotransferase (U/L)
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
2 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Alkaline Phosphatase (U/L)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Aspartate Aminotransferase (U/L)
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
3 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Bilirubin (umol/L)
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Creatinine (umol/L)
|
2 Number of participants
|
1 Number of participants
|
1 Number of participants
|
2 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Glucose (mmol/L)
|
1 Number of participants
|
2 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Potassium (mmol/L) (Hyperkalemia)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Potassium (mmol/L) (Hypokalemia)
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Sodium (mml/L) (Hypernatremia)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Sodium (mml/L) (Hyponatremia)
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
BiCarbonate (mmol/L)
|
1 Number of participants
|
2 Number of participants
|
2 Number of participants
|
4 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 7 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Urea Nitrogen (mmol/L)
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
3 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
ECG Overall Shift from Baseline
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Head - Week 16 post dose abnormal - Not clinically Significant (NCS)
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Head - Week 20 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neck - Week 14 post dose abnormal -Clinically Significant (CS)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Eyes - Week 14 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Ears, Nose, Throat - Week 12 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Chest - Week 2 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Heart - Week 11 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Heart - Week 16 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Heart - Week 20 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 1 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 2 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 3 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 8 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
2 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 4 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 5 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 9 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 9 post dose abnormal CS
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 10 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
2 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 11 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 11 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 12 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 6 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Abdomen - Week 7 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 9 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 10 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 11 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 11 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 12 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 12 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 14 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 16 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 20 post dose abnormal NCS
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 1 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 2 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 3 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 4 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 5 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 5 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 6 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 6 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 7 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 12 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 7 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 8 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 8 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 9 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 14 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 14 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 16 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 16 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 20 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 20 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Neurological Systems - Week 26/EOS post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Lung - Week 7 post dose abnormal CS
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 4 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 5 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With a Change From Baseline or Abnormal Finding From Routine Safety Assessments
Physical Exam - Skin - Week 6 post dose abnormal NCS
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: Baseline and Post Dose (Day15 post infusion to Week26/End of Study)Change from baseline in FIX concentrate consumption.
Outcome measures
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
FIX Concentrate Usage
Annualised Total Units (IU) of FIX Concentrate Consumption at Baseline
|
501500 International Units (IU)
Standard Deviation 300520.38
|
1219000 International Units (IU)
Standard Deviation 72124.89
|
968000 International Units (IU)
Standard Deviation 14142.14
|
350947.5 International Units (IU)
Standard Deviation 112653.53
|
|
FIX Concentrate Usage
Annualised Total Total Units (IU) of FIX Concentrate Consumption Post-Dose (Day 15 to Week 26/EOS)
|
0 International Units (IU)
Standard Deviation 0
|
0 International Units (IU)
Standard Deviation 0
|
0 International Units (IU)
Standard Deviation 0
|
0 International Units (IU)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline and Post-Dose (Day 15 to Week 26/EOS)Change from baseline in annualised bleeding rate (ABR)
Outcome measures
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Bleeding Frequency
ABR at Baseline (over last 3 years)
|
4.665 Bleeds per year
Standard Deviation 0.9405
|
4.330 Bleeds per year
Standard Deviation 4.2426
|
1.0 Bleeds per year
Standard Deviation 1.4142
|
2.335 Bleeds per year
Standard Deviation 1.1208
|
|
Bleeding Frequency
ABR at Post-Dose (Day 15 to WEek 26/EOS)
|
2.175 Bleeds per year
Standard Deviation 3.0759
|
0 Bleeds per year
Standard Deviation 0
|
2.160 Bleeds per year
Standard Deviation 3.0547
|
0.548 Bleeds per year
Standard Deviation 1.0950
|
SECONDARY outcome
Timeframe: Week 1, week 2, week 3, week 6, week 9, week 12, week 16, week 20 and week 26/EOS post infusionPopulation: Immune response to the FIX transgene product (ie, development of inhibitors) was assessed by measurement of the level of inhibitors. The FIX inhibitor titre results could not be quantified accurately where a participants basal FIX activity was \>20%. Where this occurred the FIX inhibitor values could not be measured and was deemed missing.
Immune response to the human FIX transgene product (i.e., development of FIX neutralising antibodies referred to as inhibitors) will be assessed by measurement of the level of inhibitors.
Outcome measures
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Immune Response - Development of Inhibitors
Week 1 · <0.4 BU
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 1 · Missing
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Immune Response - Development of Inhibitors
Week 2 · <0.4 BU
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 2 · Missing
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Immune Response - Development of Inhibitors
Week 3 · <0.4 BU
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 3 · Missing
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Immune Response - Development of Inhibitors
Week 6 · <0.4 BU
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 6 · Missing
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Immune Response - Development of Inhibitors
Week 9 · <0.4 BU
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 9 · Missing
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Immune Response - Development of Inhibitors
Week 12 · <0.4 BU
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 12 · Missing
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Immune Response - Development of Inhibitors
Week 16 · <0.4 BU
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 16 · Missing
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Immune Response - Development of Inhibitors
Week 20 · <0.4 BU
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 20 · Missing
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Immune Response - Development of Inhibitors
Week 26/EOS · <0.4 BU
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Immune Response - Development of Inhibitors
Week 26/EOS · Missing
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From screening until time to unquantifiable results of vector genomes in all matrices, up to an average of 5.14 weeksPopulation: Vector Genomes in Plasma, Saliva, Urine, Stool and Semen: Time to unquantifiable results (weeks)
Serum and bodily secretions will be collected to assess clearance of vector genomes
Outcome measures
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Viral Shedding Evaluated as Time to Unquantifiable Vector Genomes
Plasma
|
1.355 Weeks
Standard Deviation 1.1102
|
1.715 Weeks
Standard Deviation 0.6010
|
1.425 Weeks
Standard Deviation 1.0112
|
1.750 Weeks
Standard Deviation 0.6320
|
|
Viral Shedding Evaluated as Time to Unquantifiable Vector Genomes
Saliva
|
0.570 Weeks
Standard Deviation 0.000
|
2.570 Weeks
Standard Deviation 0.6081
|
1.355 Weeks
Standard Deviation 1.1102
|
2.143 Weeks
Standard Deviation 0.9972
|
|
Viral Shedding Evaluated as Time to Unquantifiable Vector Genomes
Semen
|
2.285 Weeks
Standard Deviation 0.2051
|
3.070 Weeks
Standard Deviation 0.0990
|
2.640 Weeks
Standard Deviation 0.7071
|
3.750 Weeks
Standard Deviation 1.0357
|
|
Viral Shedding Evaluated as Time to Unquantifiable Vector Genomes
Stool
|
2.930 Weeks
Standard Deviation 0.7071
|
4.290 Weeks
Standard Deviation 1.4142
|
5.140 Weeks
Standard Deviation 1.4142
|
3.788 Weeks
Standard Deviation 0.5007
|
|
Viral Shedding Evaluated as Time to Unquantifiable Vector Genomes
Urine
|
1.355 Weeks
Standard Deviation 1.1102
|
2.070 Weeks
Standard Deviation 0.0990
|
2.140 Weeks
Standard Deviation 0.0000
|
1.178 Weeks
Standard Deviation 0.7590
|
SECONDARY outcome
Timeframe: From screening until week 26 post infusionPopulation: Endogenous FIX production at visit week 26/EOS
The proportion of patients achieving FIX activity at or above 5%, 15%, 30%, 40%, 50%, 70% and 150% of normal, at each scheduled visit, will be summarised by dose and overall.
Outcome measures
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Endogenous FIX Production
FIX Activity ≥15% of Normal
|
2 Number of participants
|
2 Number of participants
|
1 Number of participants
|
4 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥30% of Normal
|
2 Number of participants
|
2 Number of participants
|
1 Number of participants
|
4 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥40% of Normal
|
2 Number of participants
|
2 Number of participants
|
1 Number of participants
|
4 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥50% of Normal
|
0 Number of participants
|
2 Number of participants
|
1 Number of participants
|
4 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥70% of Normal
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
3 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥5% and ≤150% of Normal
|
2 Number of participants
|
1 Number of participants
|
2 Number of participants
|
2 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥15% and ≤150% of Normal
|
2 Number of participants
|
1 Number of participants
|
1 Number of participants
|
2 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥30% and ≤150% of Normal
|
2 Number of participants
|
1 Number of participants
|
1 Number of participants
|
2 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥40% and ≤150% of Normal
|
2 Number of participants
|
1 Number of participants
|
1 Number of participants
|
2 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥50% and ≤150% of Normal
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
2 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥70% and ≤150% of Normal
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Endogenous FIX Production
FIX Activity ≥5% of Normal
|
2 Number of participants
|
2 Number of participants
|
2 Number of participants
|
4 Number of participants
|
SECONDARY outcome
Timeframe: Week 26/EOSPopulation: Absolute change from baseline in FIX production (% FIX activity) at week 26/EOS
Absolute change from baseline in FIX production (% FIX activity) at week 26/EOS will be summarised.
Outcome measures
| Measure |
FLT180a First Dose
n=2 Participants
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 Participants
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 Participants
1x10e\^12 vg/kg solution for infusion
|
FLT180a Fourth Dose
n=4 Participants
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Change From Baseline in FIX Activity as a Percentage of Normal Values
|
40 FIX Activity (%)
Standard Deviation 7.07
|
155.5 FIX Activity (%)
Standard Deviation 157.68
|
32.0 FIX Activity (%)
Standard Deviation 41.01
|
129.3 FIX Activity (%)
Standard Deviation 65.7
|
Adverse Events
FLT180a First Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
FLT180a Second Dose
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
FLT180a Third Dose
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
FLT180a Forth Dose
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FLT180a First Dose
n=2 participants at risk
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 participants at risk
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 participants at risk
1x10e\^12 vg/kg solution for infusion
|
FLT180a Forth Dose
n=4 participants at risk
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Investigations
Increased ALT
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
100.0%
2/2 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
100.0%
2/2 • Number of events 3 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Raised Troponin
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Raised Amylase
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Chest Sepsis (no more information)
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Drop in Factor IX
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Transaminitis
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
75.0%
3/4 • Number of events 4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Tacrolimus Toxicity
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
Other adverse events
| Measure |
FLT180a First Dose
n=2 participants at risk
6x10e\^11 vg/kg solution for infusion
|
FLT180a Second Dose
n=2 participants at risk
2x10e\^12 vg/kg solution for infusion
|
FLT180a Third Dose
n=2 participants at risk
1x10e\^12 vg/kg solution for infusion
|
FLT180a Forth Dose
n=4 participants at risk
1.3x10e\^12 vg/kg solution for infusion
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
100.0%
2/2 • Number of events 5 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
100.0%
2/2 • Number of events 3 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
75.0%
3/4 • Number of events 4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Coagulation factor IX level increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
100.0%
2/2 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Blood bilirubin increased
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Coagulation factor IX level decreased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Drug level increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Troponin increased
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
75.0%
3/4 • Number of events 5 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 3 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
75.0%
3/4 • Number of events 8 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 3 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • Number of events 3 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
75.0%
3/4 • Number of events 5 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Feeling hot
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Pain
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Malaise
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
100.0%
4/4 • Number of events 10 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
75.0%
3/4 • Number of events 3 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 3 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
100.0%
2/2 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
2/4 • Number of events 2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
50.0%
1/2 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/2 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • From consent to Week 26 post dose/End of Study visit or early withdrawal of patient (up to 38 weeks).
Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place