Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE) (NCT NCT04351243)
NCT ID: NCT04351243
Last Updated: 2021-12-14
Results Overview
"Incidence" is defined as the percent of subjects that died by Day 43
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
227 participants
Primary outcome timeframe
Day 43
Results posted on
2021-12-14
Participant Flow
Participant milestones
| Measure |
Gimsilumab
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8
Gimsilumab: Gimsilumab is a fully human monoclonal antibody (mAb).
|
Placebo
Normal saline on Day 1 Normal saline on Day 8
Placebo: Normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
113
|
|
Overall Study
Completed Baseline Assessment
|
113
|
112
|
|
Overall Study
COMPLETED
|
74
|
75
|
|
Overall Study
NOT COMPLETED
|
40
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Baseline characteristics by cohort
| Measure |
Gimsilumab
n=113 Participants
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8
Gimsilumab: Gimsilumab is a fully human monoclonal antibody (mAb).
|
Placebo
n=112 Participants
Normal saline on Day 1 Normal saline on Day 8
Placebo: Normal saline
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 14.66 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 14.27 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 14.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 43Population: Intent-to-Treat
"Incidence" is defined as the percent of subjects that died by Day 43
Outcome measures
| Measure |
Gimsilumab
n=113 Participants
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb)
|
Placebo
n=112 Participants
Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline
|
|---|---|---|
|
Incidence of Mortality
|
32 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Day 29Population: Intent-to-Treat
Outcome measures
| Measure |
Gimsilumab
n=113 Participants
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb)
|
Placebo
n=112 Participants
Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline
|
|---|---|---|
|
Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation
|
80 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Intent-to-Treat
Subjects who die will be assigned "0" ventilator-free days
Outcome measures
| Measure |
Gimsilumab
n=113 Participants
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb)
|
Placebo
n=112 Participants
Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline
|
|---|---|---|
|
Number of Ventilator-free Days
|
29.0 Days
Interval 2.0 to 29.0
|
29.0 Days
Interval 4.0 to 29.0
|
SECONDARY outcome
Timeframe: Baseline to Day 43Population: Intent-to-Treat
Outcome measures
| Measure |
Gimsilumab
n=113 Participants
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb)
|
Placebo
n=112 Participants
Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline
|
|---|---|---|
|
Time to Hospital Discharge
|
13.0 Days
Interval 10.0 to 18.0
|
15.0 Days
Interval 9.0 to 19.0
|
Adverse Events
Gimsilumab
Serious events: 47 serious events
Other events: 84 other events
Deaths: 32 deaths
Placebo
Serious events: 45 serious events
Other events: 77 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Gimsilumab
n=113 participants at risk
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb)
|
Placebo
n=112 participants at risk
Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.8%
19/113 • Number of events 20 • Adverse events through Day 43
|
17.9%
20/112 • Number of events 21 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.3%
6/113 • Number of events 7 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 6 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.7%
3/113 • Number of events 3 • Adverse events through Day 43
|
4.5%
5/112 • Number of events 5 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
1.8%
2/112 • Number of events 2 • Adverse events through Day 43
|
|
General disorders
Multiple organ dysfunction syndrome
|
7.1%
8/113 • Number of events 8 • Adverse events through Day 43
|
1.8%
2/112 • Number of events 2 • Adverse events through Day 43
|
|
General disorders
Death
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
General disorders
Sudden cardiac death
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Infections and infestations
Sepsis
|
4.4%
5/113 • Number of events 5 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Infections and infestations
Septic shock
|
6.2%
7/113 • Number of events 7 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 6 • Adverse events through Day 43
|
|
Infections and infestations
Pneumonia pseudomonal
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Cardiac disorders
Pulseless electrical activity
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
1.8%
2/112 • Number of events 2 • Adverse events through Day 43
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.7%
3/113 • Number of events 3 • Adverse events through Day 43
|
2.7%
3/112 • Number of events 4 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
2.7%
3/112 • Number of events 3 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.88%
1/113 • Number of events 2 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Infections and infestations
Pneumonia
|
2.7%
3/113 • Number of events 3 • Adverse events through Day 43
|
2.7%
3/112 • Number of events 3 • Adverse events through Day 43
|
|
Infections and infestations
Covid-19 pneumonia
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Infections and infestations
Bacteraemia
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Infections and infestations
Bacterial sepsis
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Infections and infestations
Chest wall abscess
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Infections and infestations
Pneumonia bacterial
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Infections and infestations
Postoperative wound infection
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Infections and infestations
Viral sepsis
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Infections and infestations
Device related infection
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Infections and infestations
Severe acute respiratory syndrom
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
General disorders
Non-cardiac chest pain
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
General disorders
Complications associated with device
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
3/113 • Number of events 3 • Adverse events through Day 43
|
8.0%
9/112 • Number of events 9 • Adverse events through Day 43
|
|
Renal and urinary disorders
Renal failure
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Renal and urinary disorders
Hematuria
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
3/113 • Number of events 3 • Adverse events through Day 43
|
2.7%
3/112 • Number of events 3 • Adverse events through Day 43
|
|
Cardiac disorders
Cardiac arrest
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Vascular disorders
Hypotension
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
2.7%
3/112 • Number of events 3 • Adverse events through Day 43
|
|
Vascular disorders
Venous thrombosis limb
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Vascular disorders
Shock
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
3.6%
4/112 • Number of events 4 • Adverse events through Day 43
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/113 • Adverse events through Day 43
|
1.8%
2/112 • Number of events 2 • Adverse events through Day 43
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
2.7%
3/112 • Number of events 3 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Gastrointestinal disorders
Dysphagia
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
0.00%
0/112 • Adverse events through Day 43
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Injury, poisoning and procedural complications
Tissue injury
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Investigations
Transaminases increased
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/113 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
Other adverse events
| Measure |
Gimsilumab
n=113 participants at risk
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 Gimsilumab:Gimsilumab is a fully human monoclonal antibody (mAb)
|
Placebo
n=112 participants at risk
Normal saline on Day 1 Normal saline on Day 8 Placebo: Normal saline
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
18.6%
21/113 • Number of events 22 • Adverse events through Day 43
|
17.9%
20/112 • Number of events 22 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.3%
6/113 • Number of events 7 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 6 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.5%
4/113 • Number of events 4 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 7 • Adverse events through Day 43
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/113 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 6 • Adverse events through Day 43
|
|
Infections and infestations
Septic shock
|
7.1%
8/113 • Number of events 8 • Adverse events through Day 43
|
7.1%
8/112 • Number of events 8 • Adverse events through Day 43
|
|
Infections and infestations
Pneumonia
|
6.2%
7/113 • Number of events 7 • Adverse events through Day 43
|
2.7%
3/112 • Number of events 3 • Adverse events through Day 43
|
|
Infections and infestations
Sepsis
|
5.3%
6/113 • Number of events 6 • Adverse events through Day 43
|
0.89%
1/112 • Number of events 1 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
9/113 • Number of events 9 • Adverse events through Day 43
|
7.1%
8/112 • Number of events 9 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
6/113 • Number of events 6 • Adverse events through Day 43
|
4.5%
5/112 • Number of events 5 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.7%
3/113 • Number of events 3 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 6 • Adverse events through Day 43
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
7.1%
8/112 • Number of events 9 • Adverse events through Day 43
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
8/113 • Number of events 8 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 7 • Adverse events through Day 43
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
6/113 • Number of events 6 • Adverse events through Day 43
|
6.2%
7/112 • Number of events 7 • Adverse events through Day 43
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
2/113 • Number of events 2 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 6 • Adverse events through Day 43
|
|
Renal and urinary disorders
Acute kidney injury
|
9.7%
11/113 • Number of events 12 • Adverse events through Day 43
|
12.5%
14/112 • Number of events 14 • Adverse events through Day 43
|
|
Gastrointestinal disorders
Constipation
|
8.8%
10/113 • Number of events 10 • Adverse events through Day 43
|
7.1%
8/112 • Number of events 8 • Adverse events through Day 43
|
|
Vascular disorders
Hypotension
|
7.1%
8/113 • Number of events 8 • Adverse events through Day 43
|
8.0%
9/112 • Number of events 10 • Adverse events through Day 43
|
|
Vascular disorders
Shock
|
0.88%
1/113 • Number of events 1 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 6 • Adverse events through Day 43
|
|
General disorders
Multiple organ dysfunction syndrome
|
8.0%
9/113 • Number of events 9 • Adverse events through Day 43
|
1.8%
2/112 • Number of events 2 • Adverse events through Day 43
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
8/113 • Number of events 8 • Adverse events through Day 43
|
5.4%
6/112 • Number of events 6 • Adverse events through Day 43
|
Additional Information
Simon Lowry, MD, Chief Medical Officer
Kinevant Sciences, Inc. on behalf of Kinevant Sciences GmbH
Phone: (646) 495-5368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PIs generally may not publish/present on study results before sponsor's first publication. If there is no sponsor publication within 12-18 months after study completion \[timeframe may vary among PIs\], PIs may publish/present results from only their site, provided the PI submits the publication to sponsor for review. Upon sponsor's request, PIs must delete references to sponsor's confidential information and delay publication to allow sponsor to obtain IP protection.
- Publication restrictions are in place
Restriction type: OTHER