Trial Outcomes & Findings for Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome (NCT NCT03205995)
NCT ID: NCT03205995
Last Updated: 2025-12-10
Results Overview
The primary outcome to be measured is platelet count change from baseline.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
6 participants
Primary outcome timeframe
Week 26
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
OMS721 (Narsoplimab)
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
OMS721 (Narsoplimab)
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
Poland
|
3 participants
n=6 Participants
|
|
Region of Enrollment
Lithuania
|
3 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Any patent who received drug
The primary outcome to be measured is platelet count change from baseline.
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Platelet Count (10^9 Platelets/L) Change From Baseline at Week 26
|
42 10^9 platelets/L
Interval -21.0 to 115.5
|
SECONDARY outcome
Timeframe: Pre-dose and up to 771 days post-dosePopulation: The safety population includes all participants who received any amount of study drug.
Assessment of safety of OMS721 (narsoplimab) in participants with aHUS by incidence of Adverse Events, clinically significant vital sign abnormalities, ECG abnormalities, and clinical laboratory test abnormalities
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Safety as Measured by Incidences of Adverse Events, Vital Signs, ECG, and Clinical Laboratory Tests
|
6 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Any patient who received drug
Complete TMA response defined as normalization of platelet count, normalization of serum lactate dehydrogenase (LDH), and \> 25% decrease in serum creatinine by at least 2 consecutive measures over at least 4 consecutive weeks, within the initial 26-week period
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Thrombotic Microangiopathies (TMA) Response
|
0 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Any patient who received drug
No decrease in platelet count of \> 25% from baseline, no plasma exchange or plasma infusion, and no initiation of new dialysis over at least 12 consecutive weeks, within the initial 26-week period
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
TMA Event-free Status
|
2 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Any patient who received drug
Increase of greater than 15 ml/min/1.73 m2 in eGFR calculated by the modification of diet in renal disease (MDRD) Equation
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Increase in Estimated Glomerular Filtration Rate (eGFR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Any patient who received drug
Normalization of platelet count and normalization of serum LDH by 2 consecutive measurements over at least 4 weeks, within the initial 26-week period
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Hematological Normalization
|
1 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Any patient who received drug
Platelet count greater than or equal to 150,000/μL on at least 2 consecutive measures over at least 2 consecutive weeks, within the initial 26-week period
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
TMA Remission
|
2 Participants
|
SECONDARY outcome
Timeframe: 771 days post-dosePopulation: Any patient who received drug
Incidences of ADA in participants with aHUS, administered OMS721 (narsoplimab)
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Incidence of Antidrug Antibodies (ADA)
|
1 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Any patient who received drug
Assessment of subject's change from baseline in serum creatinine.
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Change From Baseline in Serum Creatinine (mg/dL)
|
1.53 mg/dL
Interval -0.98 to 3.16
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Any patient who received drug.
Assessment of subject's change from baseline in serum LDH
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Change From Baseline in Serum LDH (U/L)
|
-12 U/L
Interval -112.0 to 389.0
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Any patient who received drug.
Assessment of subject's change from baseline in haptoglobin
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Change From Baseline in Haptoglobin (mg/dL)
|
30 mg/dL
Interval 4.0 to 56.0
|
SECONDARY outcome
Timeframe: Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (RT) (if occurs): RT Days 1-4; Follow-Up at Day 771Population: Pharmacokinetics trough plasma concentrations are provided on the pre-dose levels for the six patients enrolled.
Pharmacokinetics (PK): Trough plasma concentration, lower limit of quantification (LLOQ)
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Pharmacokinetics (PK): Trough Plasma Concentration, Lower Limit of Quantification (LLOQ)
|
15477.2 ng/mL
Standard Deviation 6471.62
|
SECONDARY outcome
Timeframe: Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (if occurs): RT Days 1-4; Follow-Up at Day 771Population: The observed Cmax values on the 6 patients have been provided.
Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Pharmacokinetics (PK): Maximum Plasma Concentrations (Cmax)
|
48350 ng/mL
Interval 25100.0 to 86300.0
|
SECONDARY outcome
Timeframe: Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (if occurs): RT Days 1-4; Follow-Up at Day 771Population: PK modeling for calculating the AUC was not performed because the study was not completed.
Pharmacokinetics (PK): Area under time-concentration curve (AUC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (if occurs): RT Days 1-4; Follow-Up at Day 771Population: Any patient who received drug and measurable C3 activity.
Pharmacodynamics (PD): Inhibition of C3 activity
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Pharmacodynamics (PD): Inhibition of C3 Activity (%)
|
84.4 Inhibition of C3 activity (%)
Interval 1.7 to 101.4
|
SECONDARY outcome
Timeframe: Days 1-4; Treatment Maintenance (103 weeks): 17 visits; Rescue Therapy (if occurs): RT Days 1-4; Follow-Up at Day 771Population: Any patient who received drug and measurable C4 activity.
Pharmacodynamics (PD): Inhibition of C4 activity
Outcome measures
| Measure |
OMS721 (Narsoplimab)
n=6 Participants
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Pharmacodynamics (PD): Inhibition of C4 Activity (%)
|
91.9 Inhibition of C4 activity (%)
Interval 11.9 to 99.9
|
Adverse Events
OMS721 (Narsoplimab)
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
OMS721 (Narsoplimab)
n=6 participants at risk
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Vascular disorders
HYPERTENSION
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Cardiac disorders
Cardiac failure
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
RENAL GRAFT INFECTION
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Nervous system disorders
CEREBRAL HEMATOMA
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Blood and lymphatic system disorders
HAEMOLYSIS
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Immune system disorders
CHRONIC ALLOGRAFT NEPHROPATHY
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Immune system disorders
KIDNEY TRANSPLANT REJECTION
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUSE FISTULA ANEURYSM
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
PNEUMONIA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
URINARY TRACT INFECTION
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Injury, poisoning and procedural complications
SHUNT BLOOD FLOW EXCESSIVE
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
Other adverse events
| Measure |
OMS721 (Narsoplimab)
n=6 participants at risk
Administration of OMS721 (narsoplimab)
OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections
|
|---|---|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Nervous system disorders
EPILEPSY
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Nervous system disorders
HEADACHE
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Nervous system disorders
NEUROLOGICAL SYMPTOM
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Psychiatric disorders
AGRESSION
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Psychiatric disorders
ANXIETY
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Renal and urinary disorders
HAEMATURIA
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Renal and urinary disorders
LEUKOCYTURIA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Reproductive system and breast disorders
AMENORRHOEA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.3%
2/6 • Number of events 3 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Vascular disorders
HYPERTENSION
|
33.3%
2/6 • Number of events 3 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Cardiac disorders
CARDIAC FAILURE
|
16.7%
1/6 • Number of events 5 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Congenital, familial and genetic disorders
HYPERTROPHIC CARDIOMYOPATHY
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Endocrine disorders
HYPERTHYROIDISM
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Gastrointestinal disorders
ASCITES
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Gastrointestinal disorders
DIARRHOEA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Gastrointestinal disorders
NAUSEA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
General disorders
INJECTION SITE EXTRAVASATION
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
General disorders
INJECTION SITE HAEMATOMA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
General disorders
INJECTION SITE PAIN
|
33.3%
2/6 • Number of events 3 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
General disorders
OEDEMA PERIPHERAL
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
General disorders
PYREXIA
|
50.0%
3/6 • Number of events 4 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Immune system disorders
CHRONIC ALLOGRAFT NEPHROPATHY
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Immune system disorders
HYPERSENSITIVITY
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Immune system disorders
KIDNEY TRANSPLANT REJECTION
|
16.7%
1/6 • Number of events 3 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
ARTERIOVENOUS FISTULA SITE INFECTION
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
BACTERIAL INFECTION
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
INFECTION
|
33.3%
2/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
MOLLUSCUM CONTAGIOSUM
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
RENAL GRAFT INFECTION
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
UREAPLASMA INFECTION
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Infections and infestations
URINARY TRACT INFECTION ENTEROCOCCAL
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA ANEURYSUM
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Injury, poisoning and procedural complications
SHUNT BLOOD FLOW EXCESSIVE
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
16.7%
1/6 • Number of events 4 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Investigations
HUMAN CHORIONIC GONADOTROPIN ABNORMAL
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Investigations
TREPONEMA TEST POSITIVE
|
16.7%
1/6 • Number of events 1 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
50.0%
3/6 • Number of events 9 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Cardiac disorders
BRADYCARDIA
|
16.7%
1/6 • Number of events 2 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
|
Blood and lymphatic system disorders
HAEMOLYSIS
|
33.3%
2/6 • Number of events 4 • From Day 1 to Final Study Visit (up to Day 771)
{Not specified}
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER