Trial Outcomes & Findings for An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen) (NCT NCT03675126)
NCT ID: NCT03675126
Last Updated: 2024-09-19
Results Overview
A TEAE was any untoward medical occurrence in a clinical study participant that did not necessarily have a causal relationship with the study drug. A TEAE could, therefore, be any unfavorable and unintended symptom, sign, disease, condition, or test abnormality that occurred during or after administration of the study drug, whether or not considered related to the study drug. A summary of serious and all other non-serious TEAEs regardless of causality is located in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to approximately 135 weeks
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
SRP-5051
Participants received SRP-5051 via intravenous (IV) infusion every 4 weeks (Q4W).
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
15
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
SRP-5051
Participants received SRP-5051 via intravenous (IV) infusion every 4 weeks (Q4W).
|
|---|---|
|
Overall Study
Study Terminated by Sponsor
|
9
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)
Baseline characteristics by cohort
| Measure |
SRP-5051
n=15 Participants
Participants received SRP-5051 via IV infusion Q4W.
|
|---|---|
|
Age, Continuous
|
16.5 years
STANDARD_DEVIATION 2.80 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 135 weeksPopulation: Safety Set: all participants who started the study drug infusion.
A TEAE was any untoward medical occurrence in a clinical study participant that did not necessarily have a causal relationship with the study drug. A TEAE could, therefore, be any unfavorable and unintended symptom, sign, disease, condition, or test abnormality that occurred during or after administration of the study drug, whether or not considered related to the study drug. A summary of serious and all other non-serious TEAEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
SRP-5051
n=15 Participants
Participants received SRP-5051 via IV infusion Q4W.
|
|---|---|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 84, every 84 days after Day 84 (up to a maximum of approximately 135 weeks) (pre-dose, immediately prior to end of infusion, up to 4-6 hours post-dose)Population: Pharmacokinetic Set: all participants who started the study drug infusion and had at least 1 PK concentration data collection.
For pharmacokinetic (PK) analysis, plasma samples were collected pre-dose (approximately 30 minutes prior to the start of infusion), immediately prior to the end of infusion (prior to flush), and approximately 4 to 6 hours after the end of dosing. Results are reported in micrograms/liter (ug/L) and are presented as an average across the days specified in the time frame.
Outcome measures
| Measure |
SRP-5051
n=15 Participants
Participants received SRP-5051 via IV infusion Q4W.
|
|---|---|
|
Plasma Concentration of SRP-5051
Pre-dose
|
486.25 ug/L
Standard Deviation 7717.595
|
|
Plasma Concentration of SRP-5051
End of Infusion
|
45244.93 ug/L
Standard Deviation 42639.411
|
|
Plasma Concentration of SRP-5051
4-6 Hours Post-dose
|
2790.32 ug/L
Standard Deviation 10941.464
|
Adverse Events
SRP-5051
Serious events: 6 serious events
Other events: 14 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
SRP-5051
n=15 participants at risk
Participants received SRP-5051 via IV infusion Q4W.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Cardiac disorders
Cardiac arrest
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Cardiac disorders
Cardiogenic shock
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Cardiac disorders
Cardiomyopathy
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Ileus
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Malnutrition
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Nervous system disorders
Psychogenic seizure
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Renal and urinary disorders
Renal failure
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
Other adverse events
| Measure |
SRP-5051
n=15 participants at risk
Participants received SRP-5051 via IV infusion Q4W.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Cardiac disorders
Angina pectoris
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Cardiac disorders
Atrioventricular block second degree
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Dysphagia
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Melaena
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Mucous stools
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
General disorders
Catheter site pain
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
General disorders
Injection site reaction
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
General disorders
Malaise
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
General disorders
Vessel puncture site bruise
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Ear infection
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Gastroenteritis viral
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Hordeolum
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Tinea pedis
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Tinea versicolour
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
3/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
3/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Injury, poisoning and procedural complications
Back injury
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Injury, poisoning and procedural complications
Head injury
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Injury, poisoning and procedural complications
Joint injury
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Investigations
C-reactive protein increased
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Investigations
Blood glucose increased
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Investigations
Cystatin C increased
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Investigations
Glucose urine present
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Investigations
Total complement activity increased
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Investigations
Troponin I increased
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
46.7%
7/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Metabolism and nutrition disorders
Malnutrition
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Nervous system disorders
Dizziness postural
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Renal and urinary disorders
Nephrolithiasis
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Renal and urinary disorders
Crystalluria
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Renal and urinary disorders
Ketonuria
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
5/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
3/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
|
Vascular disorders
Poor venous access
|
6.7%
1/15 • Up to approximately 135 weeks
Reported safety data based upon the Safety Set: all participants who started the study drug infusion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER