Trial Outcomes & Findings for Study of DS-5141b in Patients With Duchenne Muscular Dystrophy (NCT NCT02667483)
NCT ID: NCT02667483
Last Updated: 2024-03-07
Results Overview
A treatment-emergent adverse event (TEAE) is defined as an adverse event that emerges during treatment having been absent prior to treatment or reemerges during treatment or worsens in severity during treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
48 Weeks of Part 2-Extension-2
Results posted on
2024-03-07
Participant Flow
A total of 12 participants were screened; 8 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 2 clinic centers in Japan.
Participant milestones
| Measure |
DS-5141b 2.0 mg/kg
All participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
DS-5141b 6.0 mg/kg
All participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
Baseline characteristics by cohort
| Measure |
DS-5141b 2.0 mg/kg
n=3 Participants
All participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
DS-5141b 6.0 mg/kg
n=5 Participants
All participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.3 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
7.2 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
6.9 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 Weeks of Part 2-Extension-2Population: Safety events were assessed in the Safety Analysis Set.
A treatment-emergent adverse event (TEAE) is defined as an adverse event that emerges during treatment having been absent prior to treatment or reemerges during treatment or worsens in severity during treatment.
Outcome measures
| Measure |
All: DS-5141b 2.0 mg/kg
n=3 Participants
Participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
All: DS-5141b 6.0 mg/kg
n=5 Participants
Participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE) In Participants With Duchenne Muscular Dystrophy
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Week 48 of Part 2-Extension-2Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Pharmacokinetic parameters were assessed using non-compartmental methods.
Outcome measures
| Measure |
All: DS-5141b 2.0 mg/kg
n=3 Participants
Participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
All: DS-5141b 6.0 mg/kg
n=5 Participants
Participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Pharmacokinetic Parameter Maximum Concentration (Cmax) of DS-5141a (Free Form of DS-5141b) in Participants With Duchenne Muscular Dystrophy
|
1320 ng/mL
Standard Deviation 293
|
5190 ng/mL
Standard Deviation 2590
|
PRIMARY outcome
Timeframe: Week 48 of Part 2-Extension-2Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
Pharmacokinetic parameters were assessed using non-compartmental methods.
Outcome measures
| Measure |
All: DS-5141b 2.0 mg/kg
n=3 Participants
Participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
All: DS-5141b 6.0 mg/kg
n=4 Participants
Participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Pharmacokinetic Parameter Area Under the Curve (AUC) Tau of DS-5141a (Free Form of DS-5141b) in Participants With Duchenne Muscular Dystrophy
|
23100 ng*h/mL
Standard Deviation 5920
|
102000 ng*h/mL
Standard Deviation 45600
|
PRIMARY outcome
Timeframe: Week 48 of Part 2-Extension-2Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Pharmacokinetic parameters were assessed using non-compartmental methods.
Outcome measures
| Measure |
All: DS-5141b 2.0 mg/kg
n=3 Participants
Participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
All: DS-5141b 6.0 mg/kg
n=5 Participants
Participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-5141a (Free Form of DS-5141b) in Participants With Duchenne Muscular Dystrophy
|
1.98 hours
Interval 1.88 to 4.1
|
4.07 hours
Interval 3.93 to 8.0
|
PRIMARY outcome
Timeframe: Week 48 of Part 2-Extension-2Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
Pharmacokinetic parameters were assessed using non-compartmental methods.
Outcome measures
| Measure |
All: DS-5141b 2.0 mg/kg
Participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
All: DS-5141b 6.0 mg/kg
n=1 Participants
Participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Pharmacokinetic Parameter Half-life (T1/2) of DS-5141a (Free Form of DS-5141b) in Participants With Duchenne Dystrophy
|
—
|
32.4 hours
|
PRIMARY outcome
Timeframe: Week 48 of Part 2-Extension-2Population: Dystrophin protein expression was assessed in the Efficacy Analysis Set.
Outcome measures
| Measure |
All: DS-5141b 2.0 mg/kg
n=3 Participants
Participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
All: DS-5141b 6.0 mg/kg
n=5 Participants
Participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Mean Dystrophin Protein Expression in Muscle Tissue
Post Extension Treatment: Normalized by myosin heavy chain
|
3.65 percent of normal protein expression
Standard Deviation 5.98
|
2.43 percent of normal protein expression
Standard Deviation 2.42
|
|
Mean Dystrophin Protein Expression in Muscle Tissue
Baseline: Normalized by myosin heavy chain
|
2.51 percent of normal protein expression
Standard Deviation 4.13
|
1.86 percent of normal protein expression
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: Week 48 of Part 2-Extension-2Population: Dystrophin mRNA expression was assessed in the Efficacy Analysis Set.
Outcome measures
| Measure |
All: DS-5141b 2.0 mg/kg
n=3 Participants
Participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
All: DS-5141b 6.0 mg/kg
n=5 Participants
Participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Number of Participants With Exon 45-skipped Dystrophin mRNA Expression in Muscle Tissue Posttreatment
|
3 Participants
|
5 Participants
|
Adverse Events
DS-5141b 2.0 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DS-5141b 6.0 mg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DS-5141b 2.0 mg/kg
n=3 participants at risk
All participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
DS-5141b 6.0 mg/kg
n=5 participants at risk
All participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
Other adverse events
| Measure |
DS-5141b 2.0 mg/kg
n=3 participants at risk
All participants who received a subcutaneous injection of DS-5141b 2.0 mg/kg once a week.
|
DS-5141b 6.0 mg/kg
n=5 participants at risk
All participants who received a subcutaneous injection of DS-5141b 6.0 mg/kg once a week.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Conjunctivitis
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Influenza
|
66.7%
2/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Nasopharyngitis
|
100.0%
3/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
60.0%
3/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Nervous system disorders
Tension headache
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Nervous system disorders
Intercostal neuralgia
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Eye disorders
Chalazion
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Eye disorders
Conjunctivitis allergic
|
66.7%
2/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Eye disorders
Hypermetropia
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
66.7%
2/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Gastrointestinal disorders
Anal fissure
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Skin and subcutaneous tissue disorders
Papule
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
General disorders
Injection site bruising
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
General disorders
Injection site reaction
|
100.0%
3/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
100.0%
5/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
General disorders
Injection site discolouration
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Activated partial thrombroplastin time prolonged
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Albumin urine present
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Beta 2 microglobulin urine increased
|
66.7%
2/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
60.0%
3/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Beta-N-acetyl-D-glucosaminidase increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Blood iron decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Blood uric acid increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Glucose urine
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Glucose urine present
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Urinary casts
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
White blood cell count increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Urinary sediment present
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Protein urine present
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Urine ketone body present
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Cystatin C increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Alpha 1 microglobulin increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
100.0%
5/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Investigations
Magnetic resonance imaging brain abnormal
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
0.00%
0/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
33.3%
1/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
20.0%
1/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
|
Injury, poisoning and procedural complications
Contusion
|
66.7%
2/3 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
40.0%
2/5 • Adverse events were collected from baseline up to 48 weeks post extension period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place