Trial Outcomes & Findings for Phase IIa Clinical Study of N-Rephasin® SAL200 (NCT NCT03089697)
NCT ID: NCT03089697
Last Updated: 2021-10-06
Results Overview
The safety analysis was conducted based on the data of all AEs, physical examinations, clinical laboratory tests, and vital signs (blood pressure, pulse rate, body temperature, and respiratory rate) collected from the subjects. All subjects who enrolled in this study (13 subjects in the placebo group and 12 subjects in the N RephasinⓇ SAL200 group) were defined as the Safety Set and included in the analysis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
up to 4 Week ± 5 Days
Results posted on
2021-10-06
Participant Flow
Participant milestones
| Measure |
Placebo
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
n=12 Participants
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.23 Years
n=13 Participants
|
65.33 Years
n=12 Participants
|
64.8 Years
n=25 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=13 Participants
|
5 Participants
n=12 Participants
|
10 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=13 Participants
|
7 Participants
n=12 Participants
|
15 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
13 participants
n=13 Participants
|
12 participants
n=12 Participants
|
25 participants
n=25 Participants
|
|
Height (cm)
|
165.19 cm
n=13 Participants
|
161.96 cm
n=12 Participants
|
163.6 cm
n=25 Participants
|
|
Weight (kg)
|
60.35 kg
n=13 Participants
|
59.03 kg
n=12 Participants
|
59.7 kg
n=25 Participants
|
PRIMARY outcome
Timeframe: up to 4 Week ± 5 DaysThe safety analysis was conducted based on the data of all AEs, physical examinations, clinical laboratory tests, and vital signs (blood pressure, pulse rate, body temperature, and respiratory rate) collected from the subjects. All subjects who enrolled in this study (13 subjects in the placebo group and 12 subjects in the N RephasinⓇ SAL200 group) were defined as the Safety Set and included in the analysis.
Outcome measures
| Measure |
Placebo
n=13 Participants
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
n=12 Participants
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
|---|---|---|
|
Safety Endpoints - Summary of Treatment-emergent Adverse Events (Safety Set)
TEAE (Treatment-emergent AEs)
|
12 Participants
|
10 Participants
|
|
Safety Endpoints - Summary of Treatment-emergent Adverse Events (Safety Set)
SAE
|
2 Participants
|
2 Participants
|
|
Safety Endpoints - Summary of Treatment-emergent Adverse Events (Safety Set)
AEs leading to premature termination
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: by day 14Number of Participants With Negative Result in the First Blood Culture
Outcome measures
| Measure |
Placebo
n=13 Participants
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
n=12 Participants
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
|---|---|---|
|
Efficacy Endpoints 1
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: by day 14The Proportion (Percentage) of Subjects who Died of Staphylococcus aureus Bacteremia Within 14 Days of Bacteremia Diagnosis
Outcome measures
| Measure |
Placebo
n=13 Participants
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
n=12 Participants
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
|---|---|---|
|
Efficacy Endpoint 2
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: by day 14Proportion (Percentage) of Treatment Failure Against Staphylococcus aureus Bacteremia by Day 14
Outcome measures
| Measure |
Placebo
n=13 Participants
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
n=12 Participants
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
|---|---|---|
|
Efficacy Endpoint 3
|
3 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 12 other events
Deaths: 2 deaths
N-Rephasin® SAL200
Serious events: 2 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
n=12 participants at risk
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Cardiac disorders
Acute infarction
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure, type 2
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group)
Placebo: A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
N-Rephasin® SAL200
n=12 participants at risk
To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1.
N-Rephasin® SAL200: A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
46.2%
6/13 • Number of events 6 • Up to 4 weeks +5 Days
|
33.3%
4/12 • Number of events 5 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • Number of events 3 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Number of events 4 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
25.0%
3/12 • Number of events 3 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Ileus paralytic
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
General disorders
Pyrexia
|
23.1%
3/13 • Number of events 4 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
General disorders
Chills
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 3 • Up to 4 weeks +5 Days
|
|
General disorders
Asthenia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
General disorders
Chest discomfort
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
General disorders
Disease progression
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
General disorders
Facial pain
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
General disorders
Pain
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 2 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
25.0%
3/12 • Number of events 3 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
3/13 • Number of events 3 • Up to 4 weeks +5 Days
|
25.0%
3/12 • Number of events 4 • Up to 4 weeks +5 Days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.4%
2/13 • Number of events 2 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Cellulitis
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Abscess
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Clostridium difficile infection
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Extradural abscess
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Infection
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Infective aneurysm
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Infective spondylitis
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.4%
2/13 • Number of events 2 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Skin and subcutaneous tissue disorders
Blister
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Nervous system disorders
Asterixis
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Nervous system disorders
Neuralgia
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Nervous system disorders
Seizure
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Renal and urinary disorders
Dysuria
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Vascular disorders
Hypotension
|
23.1%
3/13 • Number of events 4 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Psychiatric disorders
Delirium
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Investigations
Blood urea increased
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Investigations
Urine output decreased
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Cardiac disorders
Atrial fibrillation
|
15.4%
2/13 • Number of events 2 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Cardiac disorders
Acute myocardial infarction
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Reproductive system and breast disorders
Penis disorder
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
0.00%
0/12 • Up to 4 weeks +5 Days
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1 • Up to 4 weeks +5 Days
|
16.7%
2/12 • Number of events 2 • Up to 4 weeks +5 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/13 • Up to 4 weeks +5 Days
|
8.3%
1/12 • Number of events 1 • Up to 4 weeks +5 Days
|
Additional Information
Jun SooYoun, Ph.D. / Executive Director/ Principal researcher
Institute of iNtRON Biotechnology
Phone: +82-31-739-5332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place