Trial Outcomes & Findings for BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) (NCT NCT05780424)
NCT ID: NCT05780424
Last Updated: 2024-02-05
Results Overview
Ordinal outcome with 7 mutually exclusive categories
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
353 participants
Primary outcome timeframe
Status on Day 5
Results posted on
2024-02-05
Participant Flow
Subjects were enrolled from 43 sites in 4 countries (Denmark, Switzerland, Poland, USA). The first subject was enrolled on 16 Dec 2020 and the last subject was enrolled on 1 Mar 2021.
Participant milestones
| Measure |
BRII-196/BRII-198 Plus SOC
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
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
|
176
|
177
|
|
Overall Study
COMPLETED
|
176
|
177
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Baseline characteristics by cohort
| Measure |
BRII-196/BRII-198 Plus SOC
n=176 Participants
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=177 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=353 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
287 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
Asian
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
105 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Only ethnicity reported
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Status on Day 5Ordinal outcome with 7 mutually exclusive categories
Outcome measures
| Measure |
BRII-196/BRII-198 Plus SOC
n=173 Participants
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=177 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
|
1 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
6 = Invasive ventilation, ECMO, mechanical circulatory support, new renal replacement therapy
|
4 Participants
|
3 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
5 = Non-invasive ventilation or high flow oxygen
|
15 Participants
|
14 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
4 = Supplement oxygen (≥4 L/min or ≥4 L/min above baseline, but not high flow oxygen)
|
18 Participants
|
20 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
3 = Supplement oxygen (<4 L/min or <4 L/min above baseline, but not high flow oxygen)
|
33 Participants
|
42 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
|
58 Participants
|
57 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
1 = No limiting symptoms due to COVID-19
|
44 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Through Day 90All-cause mortality
Outcome measures
| Measure |
BRII-196/BRII-198 Plus SOC
n=176 Participants
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=177 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
|
15 Participants
|
13 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 |
BRII-196/BRII-198 Plus SOC
n=176 Participants
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=177 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
|
46 Participants
|
43 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 |
BRII-196/BRII-198 Plus SOC
n=176 Participants
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=177 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
|
58 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Through Day 90Death, SAE, clinical organ failure, serious infections through Day 90
Outcome measures
| Measure |
BRII-196/BRII-198 Plus SOC
n=176 Participants
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=177 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
|
47 Participants
|
Adverse Events
BRII-196/BRII-198 Plus SOC
Serious events: 13 serious events
Other events: 45 other events
Deaths: 15 deaths
Placebo Plus SOC
Serious events: 11 serious events
Other events: 40 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
BRII-196/BRII-198 Plus SOC
n=176 participants at risk
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=177 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
Atrial fibrillation
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Investigations
Transaminases increased
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Encephalopathy
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Syncope
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Organizing pneumonia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Orthostatic hypotension
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Extremity necrosis
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
Other adverse events
| Measure |
BRII-196/BRII-198 Plus SOC
n=176 participants at risk
* BRII-196 1000 mg solution; administered as IV infusion
* BRII-198 1000 mg solution; administered as IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
BRII-196: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.
BRII-198: BRII-198 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=177 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
Anaemia
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Pericarditis
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Sinus tachycardia
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Tachycardia
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Pneumopericardium
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Ear and labyrinth disorders
Vertigo
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
4/176 • Number of events 4 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Dysphagia
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Melena
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
General disorders
Asthenia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
General disorders
Fatigue
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
3.4%
6/177 • Number of events 6 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
General disorders
Pyrexia
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
1.1%
2/177 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Bacteraemia
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Pneumonia viral
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Pyelonephritis
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Sepsis
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Septic shock
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
1.1%
2/177 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Pneumonia bacterial
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Investigations
Blood glucose increased
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Investigations
Oxygen consumption increased
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
1.1%
2/177 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.57%
1/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Headache
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Hypoaesthesia
|
0.57%
1/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Syncope
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
1.7%
3/177 • Number of events 3 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
1.7%
3/177 • Number of events 3 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/176 • Number of events 3 • 90 days
Only Grade 3 or 4 AEs were collected.
|
2.3%
4/177 • Number of events 4 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
14/176 • Number of events 16 • 90 days
Only Grade 3 or 4 AEs were collected.
|
7.3%
13/177 • Number of events 15 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
8/176 • Number of events 8 • 90 days
Only Grade 3 or 4 AEs were collected.
|
3.4%
6/177 • Number of events 8 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
3/176 • Number of events 3 • 90 days
Only Grade 3 or 4 AEs were collected.
|
1.1%
2/177 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.57%
1/176 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Hypotension
|
4.0%
7/176 • Number of events 8 • 90 days
Only Grade 3 or 4 AEs were collected.
|
1.7%
3/177 • Number of events 3 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Shock
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/176 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.56%
1/177 • Number of events 1 • 90 days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Ear and Labyrinth
|
1.1%
2/176 • Number of events 2 • 90 days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/177 • 90 days
Only Grade 3 or 4 AEs were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place