Trial Outcomes & Findings for Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease (NCT NCT00864851)
NCT ID: NCT00864851
Last Updated: 2021-06-09
Results Overview
Left ventricular mass (LVM) was measured through echocardiography.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
Baseline, Month 12 (Week 53)
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
5
|
|
Overall Study
COMPLETED
|
17
|
18
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Patient uncooperative
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease
Baseline characteristics by cohort
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=20 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=19 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 7.23 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 11.42 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 9.34 • n=4 Participants
|
|
Age, Customized
18 to <45 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Customized
>=45 years
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Left Ventricular Mass Indexed to Height (LVMI)
|
76.1 g/m^2.7
STANDARD_DEVIATION 22.8 • n=5 Participants
|
82.6 g/m^2.7
STANDARD_DEVIATION 28.3 • n=7 Participants
|
99.3 g/m^2.7
STANDARD_DEVIATION 46.2 • n=5 Participants
|
81.5 g/m^2.7
STANDARD_DEVIATION 28.5 • n=4 Participants
|
|
Baseline Maximal Oxygen Consumption (VO2 max) at Peak Exercise
|
20.2 mL/min/kg
STANDARD_DEVIATION 6.20 • n=5 Participants
|
22.6 mL/min/kg
STANDARD_DEVIATION 6.89 • n=7 Participants
|
24.0 mL/min/kg
STANDARD_DEVIATION 11.69 • n=5 Participants
|
21.6 mL/min/kg
STANDARD_DEVIATION 7.05 • n=4 Participants
|
|
Baseline Distance Walked in 6-Minute Walk Test (6MWT)
|
459.6 m
STANDARD_DEVIATION 103.0 • n=5 Participants
|
514.3 m
STANDARD_DEVIATION 87.3 • n=7 Participants
|
530.7 m
STANDARD_DEVIATION 90.2 • n=5 Participants
|
492.8 m
STANDARD_DEVIATION 97.0 • n=4 Participants
|
|
Baseline Minnesota Living with Heart Failure Questionnaire (MLHF-Q) Summary Score
|
37.0 scores on a scale
STANDARD_DEVIATION 23.8 • n=5 Participants
|
21.1 scores on a scale
STANDARD_DEVIATION 21.0 • n=7 Participants
|
19.6 scores on a scale
STANDARD_DEVIATION 26.5 • n=5 Participants
|
28.1 scores on a scale
STANDARD_DEVIATION 23.8 • n=4 Participants
|
|
Baseline New York Heart Association (NYHA) Functional Class
Class I
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Baseline New York Heart Association (NYHA) Functional Class
Class II
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Baseline New York Heart Association (NYHA) Functional Class
Class III
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Baseline New York Heart Association (NYHA) Functional Class
Class IV
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Plasma Globotriaosylceramide (GB3)
|
6.067 nmol/ml
STANDARD_DEVIATION 3.388 • n=5 Participants
|
5.652 nmol/ml
STANDARD_DEVIATION 5.212 • n=7 Participants
|
5.292 nmol/ml
STANDARD_DEVIATION 1.865 • n=5 Participants
|
5.800 nmol/ml
STANDARD_DEVIATION 4.104 • n=4 Participants
|
|
Baseline Estimated Glomerular Filtration Rate (eGFR)
|
82.0 mL/min/1.73 m^2
STANDARD_DEVIATION 34.1 • n=5 Participants
|
78.1 mL/min/1.73 m^2
STANDARD_DEVIATION 33.8 • n=7 Participants
|
72.1 mL/min/1.73 m^2
STANDARD_DEVIATION 31.2 • n=5 Participants
|
79.2 mL/min/1.73 m^2
STANDARD_DEVIATION 33.1 • n=4 Participants
|
|
Baseline Urinary Albumin/Creatinine (A/Cr) Ratio
|
313.4 mg/g
STANDARD_DEVIATION 614.07 • n=5 Participants
|
293.4 mg/g
STANDARD_DEVIATION 521.23 • n=7 Participants
|
298.2 mg/g
STANDARD_DEVIATION 175.85 • n=5 Participants
|
303.0 mg/g
STANDARD_DEVIATION 532.27 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12 (Week 53)Population: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.
Left ventricular mass (LVM) was measured through echocardiography.
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=15 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=18 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
Total of all reporting groups.
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Left Ventricular Mass Indexed to Height (LVMI)
|
3.2 g/m^2.7
Standard Deviation 12.5
|
0.5 g/m^2.7
Standard Deviation 15.8
|
-10.3 g/m^2.7
Standard Deviation 11.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Week 53)Population: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.
Exercise tolerance as measured by VO2 max at peak exercise using the standard exponential exercise protocol (STEEP).
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=14 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=15 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=4 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
Total of all reporting groups.
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Maximal Oxygen Consumption (VO2 Max) at Peak Exercise
|
-2.0 mL/min/kg
Standard Deviation 3.24
|
-0.3 mL/min/kg
Standard Deviation 4.76
|
2.2 mL/min/kg
Standard Deviation 5.85
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Week 53)Population: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.
Exercise tolerance using the 6MWT was measured as the total distance walked in 6 minutes.
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=15 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=18 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
Total of all reporting groups.
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Distance Walked in 6-Minute Walk Test (6MWT)
|
-10.4 m
Standard Deviation 87.7
|
37.9 m
Standard Deviation 70.5
|
24.7 m
Standard Deviation 45.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Week 53)Population: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.
Quality of life (QoL) was evaluated using the MLHF-Q, version 2. The questionnaire is designed to assess the degree to which heart failure symptoms affect a patient's daily life. The summary score ranges from 0 to 105, with a score of 105 representing the highest adverse impact on a patient's QoL.
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=17 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=17 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
Total of all reporting groups.
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in the Minnesota Living With Heart Failure Questionnaire (MLHF-Q) Summary Score
|
-3.1 scores on a scale
Standard Deviation 16.7
|
2.1 scores on a scale
Standard Deviation 11.5
|
-8.6 scores on a scale
Standard Deviation 12.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Week 53)Population: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.
The NYHA functional classification system relates symptoms to everyday activities and the patient's quality of life. NYHA Classification - The Stages of Heart Failure: Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=17 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=18 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
Total of all reporting groups.
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in New York Heart Association (NYHA) Functional Class
Improved ≥ 1 NYHA Functional Class
|
2 participants
|
2 participants
|
2 participants
|
—
|
|
Change From Baseline to Month 12 in New York Heart Association (NYHA) Functional Class
Maintained NYHA Functional Class
|
15 participants
|
16 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Week 53)Population: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=17 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=18 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
Total of all reporting groups.
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Plasma Globotriaosylceramide (GB3)
|
-1.046 nmol/ml
Standard Deviation 2.256
|
-2.132 nmol/ml
Standard Deviation 4.363
|
-2.076 nmol/ml
Standard Deviation 1.248
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Week 53)Population: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.
Renal function was assessed by an evaluation of change from baseline to Month 12 in eGFR as calculated using the Modification of Diet for Renal Disease (MDRD) equation.
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=17 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=18 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
Total of all reporting groups.
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)
|
-1.2 mL/min/1.73m^2
Standard Deviation 12.2
|
-3.3 mL/min/1.73m^2
Standard Deviation 12.7
|
-1.7 mL/min/1.73m^2
Standard Deviation 9.9
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Week 53)Population: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=17 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=17 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
Total of all reporting groups.
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Urinary Albumin/Creatinine (A/Cr) Ratio
|
83.9 mg/g
Standard Deviation 624.82
|
-54.1 mg/g
Standard Deviation 322.51
|
-54.2 mg/g
Standard Deviation 294.86
|
—
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal. Analyses were performed on the ITT population because it was identical to the safety population.
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
Outcome measures
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=20 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=19 Participants
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 Participants
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
n=44 Participants
Total of all reporting groups.
|
|---|---|---|---|---|
|
Safety Evaluation
No adverse event (AE)
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Safety Evaluation
At least one AE
|
19 participants
|
17 participants
|
5 participants
|
41 participants
|
|
Safety Evaluation
At least one study drug-related AE
|
6 participants
|
6 participants
|
2 participants
|
14 participants
|
|
Safety Evaluation
At least one infusion-related AE
|
5 participants
|
4 participants
|
2 participants
|
11 participants
|
|
Safety Evaluation
At least one severe or life-threatening AE
|
8 participants
|
4 participants
|
0 participants
|
12 participants
|
|
Safety Evaluation
At least one serious AE (SAE)
|
8 participants
|
5 participants
|
2 participants
|
15 participants
|
|
Safety Evaluation
At least one study drug-related SAE
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety Evaluation
Discontinued due to an AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Evaluation
Deaths
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Replagal 0.2 mg/kg, IV, Every Other Week
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
Replagal 0.2 mg/kg, IV, Weekly
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Replagal 0.4 mg/kg, IV, Weekly
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Overall
Serious events: 15 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=20 participants at risk
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=19 participants at risk
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 participants at risk
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
n=44 participants at risk
Total of all reporting groups.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Meningitis aseptic
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Inflammation
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Angina pectoris
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Coronary artery stenosis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Spastic paralysis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
Other adverse events
| Measure |
Replagal 0.2 mg/kg, IV, Every Other Week
n=20 participants at risk
Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
|
Replagal 0.2 mg/kg, IV, Weekly
n=19 participants at risk
Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
|
Replagal 0.4 mg/kg, IV, Weekly
n=5 participants at risk
Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
|
Overall
n=44 participants at risk
Total of all reporting groups.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
31.6%
6/19 • Number of events 11 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
18.2%
8/44 • Number of events 13 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Bronchitis
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.8%
3/19 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
13.6%
6/44 • Number of events 6 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
21.1%
4/19 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
9.1%
4/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.8%
3/19 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
9.1%
4/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Viral infection
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Ear infection
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Localised infection
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Meningitis aseptic
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Skin infection
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Infections and infestations
Vaginal infection
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Fatigue
|
25.0%
5/20 • Number of events 13 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
36.8%
7/19 • Number of events 13 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 13 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
29.5%
13/44 • Number of events 39 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
21.1%
4/19 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
13.6%
6/44 • Number of events 9 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Pyrexia
|
15.0%
3/20 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
13.6%
6/44 • Number of events 7 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Chest pain
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
11.4%
5/44 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Chills
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Catheter site swelling
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Feeling cold
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Feeling hot
|
5.0%
1/20 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Implant site paraesthesia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Implant site reaction
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Inflammation
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Influenza like illness
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Infusion site haematoma
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Malaise
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Pain
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
General disorders
Thirst
|
5.0%
1/20 • Number of events 8 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 8 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
3/20 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
21.1%
4/19 • Number of events 6 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.9%
7/44 • Number of events 9 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.8%
3/19 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
13.6%
6/44 • Number of events 7 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
26.3%
5/19 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
11.4%
5/44 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.8%
3/19 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
11.4%
5/44 • Number of events 6 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
9.1%
4/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 10 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 12 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
5.0%
1/20 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
9.1%
4/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Ventricular tachycardia
|
5.0%
1/20 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Angina pectoris
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Atrioventricular block first degree
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Cardiac failure
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Coronary artery stenosis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Dilatation atrial
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
21.1%
4/19 • Number of events 6 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.9%
7/44 • Number of events 11 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 6 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.8%
3/19 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
11.4%
5/44 • Number of events 10 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
40.0%
2/5 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
11.4%
5/44 • Number of events 6 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Aphasia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Aphonia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Balance disorder
|
5.0%
1/20 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Disturbance in attention
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Dizziness postural
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Hyperreflexia
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Hypoaethesia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Poor quality sleep
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Nervous system disorders
Spastic paralysis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.8%
3/19 • Number of events 9 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
11.4%
5/44 • Number of events 13 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Dental caries
|
15.0%
3/20 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
9.1%
4/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
9.1%
4/44 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Gastrointestinal disorders
Tooth impacted
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.8%
3/19 • Number of events 5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
18.2%
8/44 • Number of events 11 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
9.1%
4/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Cardiac murmur
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
9.1%
4/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Haematocrit decreased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Red blood cell count decreased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Blood creatinine phosphokinase increased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Blood glucose increased
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Blood iron decreased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Blood pressure decreased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Blood urea increased
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Body temperature decreased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Body temperature increased
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
C-reactive protein increased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Electrocardiogram QT prolonged
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Haemoglobin increased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Heart rate decreased
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Heart rate irregular
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Mean haemoglobin decreased
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
QRS axis abnormal
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Investigations
Urinary lipids present
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
15.8%
3/19 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Renal and urinary disorders
Haematuria
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Renal and urinary disorders
Renal failure chronic
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Renal and urinary disorders
Renal cyst
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
10.0%
2/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Reproductive system and breast disorders
Prostatitis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 3 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
6.8%
3/44 • Number of events 4 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Vascular disorders
Aortic stenosis
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Skin and subcutaneous tissue disorders
Haematoma
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Vascular disorders
Hot flush
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Vascular disorders
Pallor
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Vascular disorders
Peripheral coldness
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Metabolism and nutrition disorders
Gout
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Psychiatric disorders
Alcohol abuse
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Psychiatric disorders
Disorientation
|
5.0%
1/20 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
10.5%
2/19 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Eye disorders
Vision blurred
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
4.5%
2/44 • Number of events 2 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Eye disorders
Blindness
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Eye disorders
Eye pain
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Hepatobiliary disorders
Biliary dilataton
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Hepatobiliary disorders
Liver injury
|
5.0%
1/20 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Congenital, familial and genetic disorders
Myocardial bridging
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
5.3%
1/19 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/5 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/20 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
0.00%
0/19 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
20.0%
1/5 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
2.3%
1/44 • Number of events 1 • 56 Weeks
Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER