Trial Outcomes & Findings for Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia (NCT NCT03027609)
NCT ID: NCT03027609
Last Updated: 2022-03-17
Results Overview
A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
21 days following dosing
Results posted on
2022-03-17
Participant Flow
Participant milestones
| Measure |
AR-105
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
79
|
|
Overall Study
COMPLETED
|
49
|
62
|
|
Overall Study
NOT COMPLETED
|
30
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Baseline characteristics by cohort
| Measure |
AR-105
n=79 Participants
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=79 Participants
Matching placebo
placebo: matching placebo
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 13.83 • n=99 Participants
|
61.2 years
STANDARD_DEVIATION 15.58 • n=107 Participants
|
62.3 years
STANDARD_DEVIATION 14.73 • n=206 Participants
|
|
Age, Customized
Age </= 64 years
|
40 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Age, Customized
Age > 64 years
|
39 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
6 participants
n=99 Participants
|
11 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Belarus
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Georgia
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
France
|
10 participants
n=99 Participants
|
14 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
World Regions
Americas
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
World Regions
Eastern Europe
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
World Regions
Western Europe
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
World Regions
Asia
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 21 days following dosingA summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group
Outcome measures
| Measure |
AR-105
n=70 Participants
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=67 Participants
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Clinical Cure on Day 21
Imputed Cured
|
6 Participants
|
5 Participants
|
|
Clinical Cure on Day 21
Not Cured
|
25 Participants
|
20 Participants
|
|
Clinical Cure on Day 21
Reinfection same pathogen
|
5 Participants
|
2 Participants
|
|
Clinical Cure on Day 21
New Infection Different Pathogen
|
0 Participants
|
3 Participants
|
|
Clinical Cure on Day 21
Observed Cured
|
34 Participants
|
37 Participants
|
|
Clinical Cure on Day 21
New infection Unknown pathogen
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days following dosingA summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group
Outcome measures
| Measure |
AR-105
n=70 Participants
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=67 Participants
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Clinical Cure on Day 7
Cured Observed
|
16 Participants
|
18 Participants
|
|
Clinical Cure on Day 7
Cured Imputed
|
0 Participants
|
0 Participants
|
|
Clinical Cure on Day 7
Not Cured
|
52 Participants
|
47 Participants
|
|
Clinical Cure on Day 7
Re-infection Same Pathogen
|
1 Participants
|
0 Participants
|
|
Clinical Cure on Day 7
New Infection Different Pathogen
|
1 Participants
|
1 Participants
|
|
Clinical Cure on Day 7
New Infection Unknown Pathogen
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 days following dosingA summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group
Outcome measures
| Measure |
AR-105
n=70 Participants
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=67 Participants
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Clinical Cure on Day 14
Observed Cured
|
36 Participants
|
31 Participants
|
|
Clinical Cure on Day 14
Imputed Cured
|
1 Participants
|
2 Participants
|
|
Clinical Cure on Day 14
Not Cured
|
29 Participants
|
30 Participants
|
|
Clinical Cure on Day 14
Reinfection same pathogen
|
1 Participants
|
0 Participants
|
|
Clinical Cure on Day 14
New Infection Different Pathogen
|
2 Participants
|
4 Participants
|
|
Clinical Cure on Day 14
New infection Unknown Pathogen
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 days following dosingA summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group
Outcome measures
| Measure |
AR-105
n=70 Participants
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=67 Participants
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Clinical Cure on Day 28
Not Cured
|
23 Participants
|
16 Participants
|
|
Clinical Cure on Day 28
Reinfection same pathogen
|
3 Participants
|
3 Participants
|
|
Clinical Cure on Day 28
Observed Cured
|
35 Participants
|
38 Participants
|
|
Clinical Cure on Day 28
Imputed Cured
|
9 Participants
|
6 Participants
|
|
Clinical Cure on Day 28
New Infection Different Pathogen
|
0 Participants
|
4 Participants
|
|
Clinical Cure on Day 28
New infection Unknown Pathogen
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: Up to Day 21Difference in percentage of clinical cure rates between the two treatment groups
Outcome measures
| Measure |
AR-105
n=9 Participants
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=18 Participants
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Absolute Difference Clinical Cure at Day 14 and 21 for Study 1
Cured Day 21
|
7 Participants
|
10 Participants
|
|
Absolute Difference Clinical Cure at Day 14 and 21 for Study 1
Cured Day 14
|
6 Participants
|
8 Participants
|
POST_HOC outcome
Timeframe: Up to Day 21Difference in percentage of clinical cure rates between the two treatment groups
Outcome measures
| Measure |
AR-105
n=3 Participants
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=7 Participants
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Absolute Difference Clinical Cure at Day 14 and 21 for Study 2
Cured Day 14
|
2 Participants
|
2 Participants
|
|
Absolute Difference Clinical Cure at Day 14 and 21 for Study 2
Cured Day 21
|
2 Participants
|
3 Participants
|
Adverse Events
AR-105
Serious events: 36 serious events
Other events: 73 other events
Deaths: 25 deaths
Control
Serious events: 22 serious events
Other events: 73 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
AR-105
n=79 participants at risk
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=79 participants at risk
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Vascular disorders
Circulatory Collapse
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Vascular disorders
Shock
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Vascular disorders
Shock haemorrhagic
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
General disorders
Cardiac death
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
General disorders
Multiple organ dysfunction syndrome
|
8.9%
7/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Injury, poisoning and procedural complications
Brain herniation
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Investigations
Transaminases increased
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Cardiac arrest
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Cardiac failure acute
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Cardiopulmonary failure
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Cardiovascular insufficiency
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Rhythm idioventricular
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Nervous system disorders
Brain oedema
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Nervous system disorders
Coma
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Bacteraemia
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Cholecystitis infective
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Fungal sepsis
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Lung abscess
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Pneumonia
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Pneumonia pseudomonal
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Sepsis
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Septic shock
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Systemic candida
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Vascular disorders
Arterial rupture
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
Other adverse events
| Measure |
AR-105
n=79 participants at risk
One intravenous infusion of AR-105 20mg/'kg
AR-105: monoclonal antibody
|
Control
n=79 participants at risk
Matching placebo
placebo: matching placebo
|
|---|---|---|
|
Vascular disorders
Hypotension
|
17.7%
14/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
11.4%
9/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
General disorders
Multiple organ dysfunction syndrome
|
12.7%
10/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
General disorders
Oedema peripheral
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
General disorders
Pyrexia
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Nervous system disorders
Agitation
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Atrial fibrillation
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
8.9%
7/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Cardiac disorders
Bradycardia
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Blood and lymphatic system disorders
Anaemia
|
20.3%
16/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
16.5%
13/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Nervous system disorders
Brain oedema
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Nervous system disorders
Delirium
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Nervous system disorders
Insomnia
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Constipation
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
16.5%
13/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Gastrointestinal disorders
Nausea
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Renal and urinary disorders
Acute kidney injury
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
11.4%
9/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.2%
12/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
3.8%
3/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Cystitis
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Pneumonia
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Sepsis
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
0.00%
0/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Septic shock
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
6.3%
5/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Tracheobronchitis
|
5.1%
4/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
2.5%
2/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
7.6%
6/79 • 1 month: from administration day (Day 0) up to Day 28 (28 days after administration)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place