Trial Outcomes & Findings for LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) (NCT NCT05780268)
NCT ID: NCT05780268
Last Updated: 2023-12-27
Results Overview
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
314 participants
Primary outcome timeframe
Through Day 90
Results posted on
2023-12-27
Participant Flow
Subjects were enrolled from 31 sites in 3 countries (Denmark, Singapore, USA). The first subject was enrolled on 5 Aug 2020 and the last subject was enrolled on 13 Oct 2020.
Participant milestones
| Measure |
LY3819253 Plus SOC
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
151
|
|
Overall Study
COMPLETED
|
163
|
151
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Baseline characteristics by cohort
| Measure |
LY3819253 Plus SOC
n=163 Participants
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
Total
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
240 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/Ethnicity, Customized
Race · American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
90 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Only ethnicity reported
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through Day 90Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Outcome measures
| Measure |
LY3819253 Plus SOC
n=163 Participants
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With Sustained Recovery
|
144 Participants
|
136 Participants
|
PRIMARY outcome
Timeframe: Status on Day 5Ordinal outcome with 7 mutually exclusive categories
Outcome measures
| Measure |
LY3819253 Plus SOC
n=163 Participants
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With an Ordinal Outcome on Day 5
7 = Death
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
6 = Invasive ventilation, ECMO, mechanical circulatory support, new renal replacement therapy
|
8 Participants
|
5 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
5 = Non-invasive ventilation or high flow oxygen
|
24 Participants
|
22 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
4 = Supplement oxgen (≥4 L/min or ≥4 L/min above baseline, but not high flow oxygen)
|
18 Participants
|
11 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
3 = Supplement oxgen (<4 L/min or <4 L/min above baseline, but not high flow oxygen)
|
30 Participants
|
33 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
2 = Limiting symptoms due to COVID-19, but not need of new or increased oxygen from baseline
|
51 Participants
|
45 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
1 = No limiting symptoms due to COVID-19
|
31 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Through Day 90All-cause mortality
Outcome measures
| Measure |
LY3819253 Plus SOC
n=163 Participants
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants Who Died From All Causes
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Through Day 5Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5
Outcome measures
| Measure |
LY3819253 Plus SOC
n=163 Participants
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With a Safety Outcome Through Day 5
|
45 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Through Day 28Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28
Outcome measures
| Measure |
LY3819253 Plus SOC
n=163 Participants
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With a Safety Outcome Through Day 28
|
52 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Through Day 90Death, SAE, clinical organ failure, serious infections through Day 90
Outcome measures
| Measure |
LY3819253 Plus SOC
n=163 Participants
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With a Safety Outcome Through Day 90
|
45 Participants
|
41 Participants
|
Adverse Events
LY3819253 Plus SOC
Serious events: 9 serious events
Other events: 41 other events
Deaths: 13 deaths
Placebo Plus SOC
Serious events: 12 serious events
Other events: 27 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
LY3819253 Plus SOC
n=163 participants at risk
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 participants at risk
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
General disorders
Oedema peripheral
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
General disorders
Pyrexia
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
General disorders
Systemic inflammatory response syndrome
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Infections and infestations
Paraspinal abscess
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Investigations
Haemoglobin decreased
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Metabolism and nutrition disorders
Hyponataemis
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulonary disease
|
0.61%
1/163 • Number of events 1 • 90 days
|
1.3%
2/151 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Surgical and medical procedures
Hypotension
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Hypotension
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Vascular disorders
Hypertensive urgency
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
Other adverse events
| Measure |
LY3819253 Plus SOC
n=163 participants at risk
* LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=151 participants at risk
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Cardiac disorders
Arrhythmia
|
1.2%
2/163 • Number of events 2 • 90 days
|
0.00%
0/151 • 90 days
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Cardiac disorders
Bradycardia
|
1.2%
2/163 • Number of events 2 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Cardiac disorders
Tachycardia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 2 • 90 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/163 • 90 days
|
1.3%
2/151 • Number of events 2 • 90 days
|
|
Gastrointestinal disorders
Pancreatitits
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
General disorders
Asthenia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
General disorders
Chills
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
General disorders
Fatigue
|
5.5%
9/163 • Number of events 10 • 90 days
|
3.3%
5/151 • Number of events 5 • 90 days
|
|
General disorders
Hypothermia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
General disorders
Odema peripheral
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
General disorders
Pain
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
General disorders
Pyrexia
|
1.2%
2/163 • Number of events 3 • 90 days
|
1.3%
2/151 • Number of events 2 • 90 days
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Infections and infestations
Pneumonia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Infections and infestations
Staphylococcal infection
|
1.2%
2/163 • Number of events 2 • 90 days
|
0.00%
0/151 • 90 days
|
|
Infections and infestations
Pseudomonas infection
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Infections and infestations
Paraspinal abscess
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Infections and infestations
Candida infection
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Investigations
Haemoglobin decreased
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Investigations
Hepatic enzyme increased
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Investigations
Liver function test increased
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
10016803
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
Hypoglyceamia
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
3/163 • Number of events 4 • 90 days
|
2.0%
3/151 • Number of events 3 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
2/163 • Number of events 2 • 90 days
|
0.00%
0/151 • 90 days
|
|
Nervous system disorders
Dizzyness
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Nervous system disorders
Headache
|
0.61%
1/163 • Number of events 1 • 90 days
|
1.3%
2/151 • Number of events 2 • 90 days
|
|
Nervous system disorders
Seizure
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Nervous system disorders
Anxiety
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Nervous system disorders
Panic attack
|
0.61%
1/163 • Number of events 1 • 90 days
|
0.00%
0/151 • 90 days
|
|
Nervous system disorders
Mental status changes
|
4.3%
7/163 • Number of events 7 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
5/163 • Number of events 7 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/163 • 90 days
|
2.0%
3/151 • Number of events 3 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.2%
15/163 • Number of events 17 • 90 days
|
6.6%
10/151 • Number of events 10 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.61%
1/163 • Number of events 1 • 90 days
|
1.3%
2/151 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumoththorax
|
0.61%
1/163 • Number of events 3 • 90 days
|
0.00%
0/151 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.2%
2/163 • Number of events 2 • 90 days
|
0.00%
0/151 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
4/163 • Number of events 4 • 90 days
|
2.0%
3/151 • Number of events 3 • 90 days
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/163 • 90 days
|
0.66%
1/151 • Number of events 1 • 90 days
|
|
Vascular disorders
Hypotension
|
3.7%
6/163 • Number of events 7 • 90 days
|
2.0%
3/151 • Number of events 3 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place