Trial Outcomes & Findings for Open-label Extension for Phase 3 Clinical Trials of Simufilam (NCT NCT05575076)
NCT ID: NCT05575076
Last Updated: 2025-05-23
Results Overview
To evaluate the long-term safety and tolerability of simufilam 100 mg tablets in subjects who have completed one of the two double-blind simufilam phase 3 studies.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1081 participants
Primary outcome timeframe
Baseline to 52 weeks
Results posted on
2025-05-23
Participant Flow
This was an open-label extension study.
Participant milestones
| Measure |
Simufilam 100 mg
simufilam 100 mg oral tablet, twice daily
Simufilam: simufilam 100 mg oral tablet, twice daily
|
|---|---|
|
Overall Study
STARTED
|
1081
|
|
Overall Study
COMPLETED
|
300
|
|
Overall Study
NOT COMPLETED
|
781
|
Reasons for withdrawal
| Measure |
Simufilam 100 mg
simufilam 100 mg oral tablet, twice daily
Simufilam: simufilam 100 mg oral tablet, twice daily
|
|---|---|
|
Overall Study
Adverse Event
|
24
|
|
Overall Study
Death
|
7
|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Non-Compliance
|
3
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Sponsor Requests to be Withdrawn
|
7
|
|
Overall Study
Withdrawal by Subject
|
71
|
|
Overall Study
Study Terminated by Sponsor
|
630
|
|
Overall Study
Other
|
17
|
Baseline Characteristics
Open-label Extension for Phase 3 Clinical Trials of Simufilam
Baseline characteristics by cohort
| Measure |
Simufilam
n=1079 Participants
simufilam 100 mg oral tablet, twice daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
144 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
935 Participants
n=5 Participants
|
|
Age, Continuous
|
73.9 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
583 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
496 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
977 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
962 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
115 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
7 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
890 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
45 participants
n=5 Participants
|
|
BMI
|
26.59 kg/m2
STANDARD_DEVIATION 6.892 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksPopulation: The number of subjects in the analysis (1079) differs by two subjects compared to the Participant Flow module (1081), because there are two subjects who were enrolled but did not receive study treatment and were not included in the Safety Analysis set.
To evaluate the long-term safety and tolerability of simufilam 100 mg tablets in subjects who have completed one of the two double-blind simufilam phase 3 studies.
Outcome measures
| Measure |
Simufilam 100mg
n=1079 Participants
simufilam 100 mg oral tablet, twice daily
|
|---|---|
|
Number of Participants With Adverse Events
Number of subjects with moderate AEs
|
198 Participants
|
|
Number of Participants With Adverse Events
Number of subjects with severe AEs
|
63 Participants
|
|
Number of Participants With Adverse Events
Number of subjects with no AEs
|
519 Participants
|
|
Number of Participants With Adverse Events
Number of subjects with mild AEs
|
299 Participants
|
Adverse Events
Simufilam 100mg
Serious events: 92 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Simufilam 100mg
n=1079 participants at risk
simufilam 100 mg oral tablet, twice daily
|
|---|---|
|
Nervous system disorders
Syncope
|
0.93%
10/1079 • Number of events 10 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.19%
2/1079 • Number of events 3 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Headache
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Aphasia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Brain stem infarction
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Encephalopathy
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Presyncope
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Nervous system disorders
Seizure
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Transient ischaemic attack
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Pneumonia
|
0.56%
6/1079 • Number of events 7 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Urinary tract infection
|
0.37%
4/1079 • Number of events 4 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
COVID-19
|
0.28%
3/1079 • Number of events 3 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Diverticulitis
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Arthritis bacterial
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Bronchitis viral
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Cystitis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Influenza
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Pulmonary sepsis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Sepsis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Urosepsis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
4/1079 • Number of events 4 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
3/1079 • Number of events 3 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Infections and infestations
Coronary artery disease
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Arrhythmia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.09%
1/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Injury, poisoning and procedural complications
Subdural haemotoma
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Colitis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.28%
3/1079 • Number of events 3 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Gastrointestinal disorders
Chronic obstructive pulmonary disease
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Psychiatric disorders
Delirium
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Psychiatric disorders
Mental status changes
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Psychiatric disorders
Agitation
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
2/1079 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
General disorders
Asthenia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
General disorders
Death
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
General disorders
Gait inability
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
General disorders
Hypothermia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostrate cancer
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Renal and urinary disorders
Haematuria
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Vascular disorders
Aortic stenosis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Vascular disorders
Hypertensive emergency
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Vascular disorders
Hypotension
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
|
Investigations
Fibrin D dimer increased
|
0.09%
1/1079 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and PI must request review and comment of any proposed publication by the sponsor at least 90 days prior to submission of the publication. The sponsor will advise of any information which is confidential information or which may impair the sponsor's ability to obtain patent protection, and has the right to require confidential information or factual errors to be removed, or to delay the proposed publication by an additional 90 days to allow the sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER