Trial Outcomes & Findings for A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock (NCT NCT01144624)
NCT ID: NCT01144624
Last Updated: 2014-10-06
Results Overview
Number of patients with treatment-emergent adverse events and number of patients who died over 28 days
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
28 day study period
Results posted on
2014-10-06
Participant Flow
Subjects were screened and enrolled at six centres in Japan.
Participant milestones
| Measure |
Dose Cohort 1
AZD9773 250/50 units/kg IV
|
Dose Cohort 2
AZD9773 500/100 units/kg IV
|
Placebo
Saline
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
6
|
|
Overall Study
Received Treatment
|
7
|
7
|
6
|
|
Overall Study
Completed Treatment
|
7
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock
Baseline characteristics by cohort
| Measure |
Dose Cohort 1
n=7 Participants
AZD9773 250/50 units/kg IV
|
Dose Cohort 2
n=7 Participants
AZD9773 500/100 units/kg IV
|
Placebo
n=6 Participants
Saline
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
77.6 years
STANDARD_DEVIATION 10.45 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 17.64 • n=5 Participants
|
75.4 years
STANDARD_DEVIATION 12.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 day study periodPopulation: Safety analysis set
Number of patients with treatment-emergent adverse events and number of patients who died over 28 days
Outcome measures
| Measure |
Arm 1 - Dose Cohort 1
n=7 Participants
AZD9773 250/50 units/kg IV
|
Arm 2 - Dose Cohort 2
n=7 Participants
AZD9773 500/100 units/kg IV
|
Arm 3 - Placebo
n=6 Participants
Saline
|
|---|---|---|---|
|
Safety and Tolerability of AZD9773
Number of Patients with Treatment-Emergent AEs
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Safety and Tolerability of AZD9773
Number of Patients who Died over 28 days
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose to last dose (Day 5/6 or at premature treatment discontinuation)Population: Pharmacokinetic analysis set
Maximum concentration at steady state (Cmax ss) for serum total and specific fabs
Outcome measures
| Measure |
Arm 1 - Dose Cohort 1
n=7 Participants
AZD9773 250/50 units/kg IV
|
Arm 2 - Dose Cohort 2
n=5 Participants
AZD9773 500/100 units/kg IV
|
Arm 3 - Placebo
Saline
|
|---|---|---|---|
|
Pharmacokinetics of AZD9773
Cmax ss for serum total fabs
|
38.48 ug/mL
Interval 30.5 to 62.4
|
71.04 ug/mL
Interval 41.7 to 90.7
|
—
|
|
Pharmacokinetics of AZD9773
Cmax ss for serum specific fabs
|
1.823 ug/mL
Interval 1.31 to 2.62
|
3.335 ug/mL
Interval 1.92 to 4.62
|
—
|
SECONDARY outcome
Timeframe: Levels taken at baseline, over the dosing period (up to Day 5/6)Population: Safety analysis set
TNF-alpha levels over approximately 6 days following the first dose
Outcome measures
| Measure |
Arm 1 - Dose Cohort 1
n=7 Participants
AZD9773 250/50 units/kg IV
|
Arm 2 - Dose Cohort 2
n=7 Participants
AZD9773 500/100 units/kg IV
|
Arm 3 - Placebo
n=6 Participants
Saline
|
|---|---|---|---|
|
Pharmacodynamic Effects of AZD9773 on TNF-alpha
TNF-alpha level at baseline
|
1.000 pg/ml
Interval 0.92 to 8.89
|
1.690 pg/ml
Interval 0.92 to 2.65
|
8.810 pg/ml
Interval 1.13 to 29.17
|
|
Pharmacodynamic Effects of AZD9773 on TNF-alpha
TNF-alpha level 1-2 hours post-first dose
|
0.920 pg/ml
Interval 0.92 to 5.93
|
0.990 pg/ml
Interval 0.92 to 2.18
|
7.425 pg/ml
Interval 0.92 to 28.4
|
|
Pharmacodynamic Effects of AZD9773 on TNF-alpha
TNF-alpha level on Day 6 (pre-morning dose)
|
1.710 pg/ml
Interval 0.92 to 14.9
|
1.140 pg/ml
Interval 0.92 to 1.57
|
1.560 pg/ml
Interval 0.92 to 3.0
|
Adverse Events
Dose Cohort 1
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Cohort 2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Cohort 1
n=7 participants at risk
AZD9773 250/50 units/kg IV
|
Dose Cohort 2
n=7 participants at risk
AZD9773 500/100 units/kg IV
|
Placebo
n=6 participants at risk
Saline
|
|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Cardiac disorders
Ventricular Tachycardia
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Nervous system disorders
Cerebral Infarction
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
Other adverse events
| Measure |
Dose Cohort 1
n=7 participants at risk
AZD9773 250/50 units/kg IV
|
Dose Cohort 2
n=7 participants at risk
AZD9773 500/100 units/kg IV
|
Placebo
n=6 participants at risk
Saline
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
2/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/7
|
28.6%
2/7
|
0.00%
0/6
|
|
Cardiac disorders
Bradycardia
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Cardiac disorders
Mitral Valve Incompetence
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Cardiac disorders
Ventricular Extrasystoles
|
14.3%
1/7
|
28.6%
2/7
|
16.7%
1/6
|
|
Cardiac disorders
Ventricular Tachycardia
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Congenital, familial and genetic disorders
Pyloric Stenosis
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Eye disorders
Conjunctival Oedema
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal Compartment Syndrome
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Anal Erosion
|
28.6%
2/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7
|
28.6%
2/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Cheilitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Colitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7
|
14.3%
1/7
|
50.0%
3/6
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrointestinal Hypomotility
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Ileus Paralytic
|
14.3%
1/7
|
28.6%
2/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Periodontitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
General disorders
Catheter Site Haematoma
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
General disorders
Device Leakage
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Disuse Syndrome
|
28.6%
2/7
|
14.3%
1/7
|
16.7%
1/6
|
|
General disorders
Fat Necrosis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Generalised Oedema
|
28.6%
2/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Injection Site Erythema
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Oedema
|
14.3%
1/7
|
28.6%
2/7
|
0.00%
0/6
|
|
General disorders
Oedema Peripheral
|
14.3%
1/7
|
42.9%
3/7
|
0.00%
0/6
|
|
General disorders
Pain
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
28.6%
2/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Infections and infestations
Abdominal Abscess
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Infections and infestations
Cellulitis Staphylococcal
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Colostomy Infection
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Fungaemia
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Infections and infestations
Herpes Zoster
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Infections and infestations
Incision Site Cellulitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Infectious Peritonitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Oral Herpes
|
14.3%
1/7
|
14.3%
1/7
|
16.7%
1/6
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia Bacterial
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia Pneumococcal
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Infections and infestations
Postoperative Wound Infection
|
28.6%
2/7
|
0.00%
0/7
|
33.3%
2/6
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Infections and infestations
Septic Shock
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Infections and infestations
Tinea Cruris
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Infections and infestations
Tracheostomy Infection
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Leak
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Incision Site Haemorrhage
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Tracheal Obstruction
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Traumatic Lung Injury
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Investigations
Blood Pressure Decreased
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Investigations
Body Temperature Increased
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Investigations
C-Reactive Protein Increased
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Investigations
Heart Rate Increased
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Investigations
Pancreatic Enzymes Increased
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Investigations
Urine Output Decreased
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Gout
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Metabolic Alkalosis
|
28.6%
2/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
14.3%
1/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Psychiatric disorders
Mental Disorder Due To A General Medical Condition
|
28.6%
2/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/7
|
28.6%
2/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/7
|
28.6%
2/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
71.4%
5/7
|
57.1%
4/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Oedema
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Polyp
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
14.3%
1/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
14.3%
1/7
|
14.3%
1/7
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Erythema
|
42.9%
3/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7
|
14.3%
1/7
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Skin Erosion
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin Haemorrhage
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin Oedema
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
28.6%
2/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Vascular Purpura
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Surgical and medical procedures
Dermabrasion
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Vascular disorders
Flushing
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Vascular disorders
Hypertension
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60