Trial Outcomes & Findings for A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease (NCT NCT00140621)
NCT ID: NCT00140621
Last Updated: 2015-05-12
Results Overview
Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
Baseline to Week 156
Results posted on
2015-05-12
Participant Flow
The study was conducted at 7 centers between July 06, 2005 and August 6, 2012. One participant was treated at 2 study sites because the participant had to be transferred to another site during the study.
Participant milestones
| Measure |
Agalsidase Beta (Fabrazyme [Recombinant Form])
Agalsidase beta 1 milligram per kilogram (mg/kg) intravenously once every 2 weeks up to 156 weeks.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
Baseline characteristics by cohort
| Measure |
Agalsidase Beta
n=6 Participants
Agalsidase beta 1 mg/kg intravenously once every 2 weeks up to 156 weeks.
|
|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Weight
|
58.50 kilograms (kg)
STANDARD_DEVIATION 9.24 • n=5 Participants
|
|
Height
|
156.63 centimeters (cm)
STANDARD_DEVIATION 7.20 • n=5 Participants
|
|
Left Ventricular Hypertrophy
No
|
0 participants
n=5 Participants
|
|
Left Ventricular Hypertrophy
Yes
|
6 participants
n=5 Participants
|
|
Globotriaosylceramide (GL-3) Accumulation in the Myocardium
No
|
0 participants
n=5 Participants
|
|
Globotriaosylceramide (GL-3) Accumulation in the Myocardium
Yes
|
1 participants
n=5 Participants
|
|
Globotriaosylceramide (GL-3) Accumulation in the Myocardium
Not Measured
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 156Population: EEP.
Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.
Outcome measures
| Measure |
Agalsidase Beta
n=6 Participants
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Percent Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156
Interventricular septum wall thickness
|
-3.31 percent change
Interval -19.67 to 16.39
|
|
Percent Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156
Left ventricular posterior wall thickness
|
-6.34 percent change
Interval -21.47 to 11.71
|
PRIMARY outcome
Timeframe: Baseline to Week 156Population: EEP.
Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.
Outcome measures
| Measure |
Agalsidase Beta
n=6 Participants
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156
Left ventricular posterior wall thickness
|
-0.33 mm
Interval -3.31 to 2.64
|
|
Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156
Interventricular septum wall thickness
|
0.37 mm
Interval -3.88 to 4.61
|
PRIMARY outcome
Timeframe: Baseline to Week 156Population: EEP.
Left ventricular mass was assessed by echocardiogram.
Outcome measures
| Measure |
Agalsidase Beta
n=6 Participants
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Percent Change From Baseline in Left Ventricular Mass (LVM) at Week 156
|
-4.14 percent change
Interval -24.35 to 21.47
|
PRIMARY outcome
Timeframe: Baseline to Week 156Population: EEP.
Left ventricular mass was assessed by echocardiogram.
Outcome measures
| Measure |
Agalsidase Beta
n=6 Participants
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Change From Baseline in LVM at Week 156
|
22.70 gm
Interval -106.57 to 151.97
|
SECONDARY outcome
Timeframe: Baseline to Week 156Population: EEP.
Overall cardiac function assessment was assessed by tests (echocardiogram,cardiac catheterization (optional),electrocardiogram,B-type natriuretic peptide \[BNP\]), clinical symptoms (subjective symptoms) and the New York Heart Association (NYHA) cardiac functional classification.Overall assessment of cardiac function was assessed based on the evaluation items including interventricular septum thickness, left ventricular posterior wall thickness, left ventricular mass, clinical function tests and clinical symptoms. A subject was considered to be Improved: if Improved in 2 items or more, Unchanged: Improved in one item and unchanged in 2 items or unchanged in all 3 items, Aggravated: Aggravated in one item or more.
Outcome measures
| Measure |
Agalsidase Beta
n=6 Participants
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Number of Participants in Overall Cardiac Function Assessment and Clinical Symptoms at Week 156: Change From Baseline in Cardiac Function Test
Improved
|
5 participants
|
|
Number of Participants in Overall Cardiac Function Assessment and Clinical Symptoms at Week 156: Change From Baseline in Cardiac Function Test
Unchanged
|
0 participants
|
|
Number of Participants in Overall Cardiac Function Assessment and Clinical Symptoms at Week 156: Change From Baseline in Cardiac Function Test
Aggravated
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 156Population: EEP.
Outcome measures
| Measure |
Agalsidase Beta
n=6 Participants
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Percent Change From Baseline in GL-3 Plasma Levels at Week 156
|
-18.91 percent change
Interval -42.35 to 14.07
|
SECONDARY outcome
Timeframe: Baseline to Week 156Population: EEP.
The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Outcome measures
| Measure |
Agalsidase Beta
n=6 Participants
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Change From Baseline in Short Form (36) Health Survey (SF-36) Scores at Week 156
Physical Health: PCS
|
6.868 units on a scale
Standard Deviation 15.238
|
|
Change From Baseline in Short Form (36) Health Survey (SF-36) Scores at Week 156
Mental Health: MCS
|
4.380 units on a scale
Standard Deviation 7.425
|
Adverse Events
Agalsidase Beta
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Agalsidase Beta
n=6 participants at risk
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
Other adverse events
| Measure |
Agalsidase Beta
n=6 participants at risk
Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
83.3%
5/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Infections and infestations
Chronic sinusitis
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Psychiatric disorders
Anxiety disorder
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Psychiatric disorders
Middle insomnia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Nervous system disorders
Intercostal neuralgia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Palpitations
|
66.7%
4/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Atrioventricular block
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Bradycardia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Bundle branch block right
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Left ventricular hypertrophy
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Cardiac disorders
Ventricular hypertrophy
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Colonic polyp
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Gastritis erosive
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
3/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
General disorders
Oedema
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
General disorders
Chest pain
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
General disorders
Chills
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
General disorders
Feeling hot
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
General disorders
Injection site inflammation
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
General disorders
Puncture site haemorrhage
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
General disorders
Tenderness
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
Blood pressure decreased
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
Blood urea increased
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
Body temperature decreased
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
Heart rate increased
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
Occult blood
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
Protein urine present
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 156) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study infusion up to Week 156).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publishing results from this study in academic meetings, medical journals, etc., the investigator and subinvestigator of the post-manufacturing/marketing clinical study must obtain the approval from the sponsor of the post-manufacturing/marketing clinical study in writing.
- Publication restrictions are in place
Restriction type: OTHER