Trial Outcomes & Findings for Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies (NCT NCT04033159)
NCT ID: NCT04033159
Last Updated: 2023-06-27
Results Overview
Number of participants with drug-related TEAEs during the study period.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Baseline until Study termination, up to 28 months
Results posted on
2023-06-27
Participant Flow
No participant was enrolled in the "Cohort 3 - High Dose" Arm/Group
Participant milestones
| Measure |
Cohort 1 - Low Dose
DYN101 in a low dose (1.5 mg/kg weekly IV)
|
Cohort 2 - Middle Dose
DYN101 in a middle dose (4.5 mg/kg weekly IV)
|
Cohort 3 - High Dose
DYN101 in a high dose (9 mg/kg weekly IV)
|
|---|---|---|---|
|
Single Ascending Dose (Day 1)
STARTED
|
6
|
8
|
0
|
|
Single Ascending Dose (Day 1)
COMPLETED
|
6
|
8
|
0
|
|
Single Ascending Dose (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period
STARTED
|
6
|
8
|
0
|
|
Washout Period
COMPLETED
|
6
|
0
|
0
|
|
Washout Period
NOT COMPLETED
|
0
|
8
|
0
|
|
Multiple Ascending Dose Period
STARTED
|
6
|
0
|
0
|
|
Multiple Ascending Dose Period
COMPLETED
|
0
|
0
|
0
|
|
Multiple Ascending Dose Period
NOT COMPLETED
|
6
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - Low Dose
DYN101 in a low dose (1.5 mg/kg weekly IV)
|
Cohort 2 - Middle Dose
DYN101 in a middle dose (4.5 mg/kg weekly IV)
|
Cohort 3 - High Dose
DYN101 in a high dose (9 mg/kg weekly IV)
|
|---|---|---|---|
|
Washout Period
Physician Decision
|
0
|
1
|
0
|
|
Washout Period
Study terminated by Sponsor
|
0
|
7
|
0
|
|
Multiple Ascending Dose Period
Study terminated by Sponsor
|
6
|
0
|
0
|
Baseline Characteristics
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
Baseline characteristics by cohort
| Measure |
Cohort 1 - Low Dose
n=6 Participants
DYN101 in a low dose (1.5 mg/kg)
|
Cohort 2 - Middle Dose
n=8 Participants
DYN101 in a middle dose (4.5 mg/kg)
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 16.49 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 16.80 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 16.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Mutation
DNM2
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Mutation
MTM1
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until Study termination, up to 28 monthsNumber of participants with drug-related TEAEs during the study period.
Outcome measures
| Measure |
Single Dose Cohort 1 - Low Dose
n=6 Participants
DYN101 in a low dose (1.5 mg/kg), single administration
|
Single Dose Cohort 2 - Middle Dose
n=8 Participants
DYN101 in a middle dose (4.5 mg/kg), single administration
|
Multiple Dose Cohort 1 - Low Dose
n=6 Participants
DYN101 in a low dose (1.5 mg/kg), weekly administration
|
|---|---|---|---|
|
Number of Participants With Drug-related Treatment Emergent Adverse Events (TEAEs)
|
1 Participants
|
5 Participants
|
6 Participants
|
Adverse Events
Single Dose Cohort 1 - Low Dose
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Single Dose Cohort 2 - Middle Dose
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Multiple Dose Cohort 1 - Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Dose Cohort 1 - Low Dose
n=6 participants at risk
DYN101 in a low dose (1.5 mg/kg), single administration
|
Single Dose Cohort 2 - Middle Dose
n=8 participants at risk
DYN101 in a middle dose (4.5 mg/kg), single administration
|
Multiple Dose Cohort 1 - Low Dose
n=6 participants at risk
DYN101 in a low dose (1.5 mg/kg), weekly administration
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
16.7%
1/6 • Number of events 1 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Ear and labyrinth disorders
Cholesteatoma
|
16.7%
1/6 • Number of events 1 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast mass
|
16.7%
1/6 • Number of events 1 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Tibia fracture
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Number of events 1 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory muscle weakness
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Number of events 1 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
Other adverse events
| Measure |
Single Dose Cohort 1 - Low Dose
n=6 participants at risk
DYN101 in a low dose (1.5 mg/kg), single administration
|
Single Dose Cohort 2 - Middle Dose
n=8 participants at risk
DYN101 in a middle dose (4.5 mg/kg), single administration
|
Multiple Dose Cohort 1 - Low Dose
n=6 participants at risk
DYN101 in a low dose (1.5 mg/kg), weekly administration
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
83.3%
5/6 • Baseline until Study termination, up to 28 months
|
|
Cardiac disorders
Arrhythmia
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
50.0%
4/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
37.5%
3/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Gastrointestinal disorders
Oral mucosal discolouration
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
General disorders
Chest pain
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
25.0%
2/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
General disorders
Eye complication associated with device
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
General disorders
Fatigue
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
25.0%
2/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
General disorders
Vessel puncture site bruise
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Immune system disorders
Immunisation reaction
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Infections and infestations
COVID-19
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Infections and infestations
Sinusitis
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
25.0%
2/8 • Baseline until Study termination, up to 28 months
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Red blood cells urine positive
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Nervous system disorders
Disturbance in attention
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
37.5%
3/8 • Baseline until Study termination, up to 28 months
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Nervous system disorders
Neuralgia
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Nervous system disorders
Anxiety
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Nervous system disorders
Sleep disorder
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
12.5%
1/8 • Baseline until Study termination, up to 28 months
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Cystatin C increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Liver function test increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
50.0%
3/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Total bile acids increased
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
33.3%
2/6 • Baseline until Study termination, up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Investigations
Dizziness
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • Baseline until Study termination, up to 28 months
|
0.00%
0/8 • Baseline until Study termination, up to 28 months
|
16.7%
1/6 • Baseline until Study termination, up to 28 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60