Trial Outcomes & Findings for Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise (NCT NCT04472494)
NCT ID: NCT04472494
Last Updated: 2022-10-07
Results Overview
The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
From first dose to 28 days post first dose
Results posted on
2022-10-07
Participant Flow
Participant milestones
| Measure |
Abatacept
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Pre-treatment
STARTED
|
42
|
19
|
|
Pre-treatment
COMPLETED
|
40
|
19
|
|
Pre-treatment
NOT COMPLETED
|
2
|
0
|
|
Treatment
STARTED
|
40
|
19
|
|
Treatment
COMPLETED
|
34
|
16
|
|
Treatment
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Abatacept
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Pre-treatment
Other reasons
|
2
|
0
|
|
Treatment
Death
|
5
|
2
|
|
Treatment
Hospital discharge
|
1
|
1
|
Baseline Characteristics
Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Baseline characteristics by cohort
| Measure |
Abatacept
n=42 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 14.20 • n=5 Participants
|
60.7 Years
STANDARD_DEVIATION 14.48 • n=7 Participants
|
61.0 Years
STANDARD_DEVIATION 14.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose to 28 days post first dosePopulation: All treated participants
The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.
Outcome measures
| Measure |
Abatacept
n=40 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
|
30.0 Percentage of participants
Interval 15.8 to 44.2
|
31.6 Percentage of participants
Interval 10.7 to 52.5
|
SECONDARY outcome
Timeframe: Baseline and on Day 28Population: All treated participants
Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1
Outcome measures
| Measure |
Abatacept
n=40 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
|
3.20 Score on a scale
Standard Error 0.395
|
2.56 Score on a scale
Standard Error 0.528
|
SECONDARY outcome
Timeframe: From first dose to 28 days post first dosePopulation: All treated participants
Percentage of participants who died due to any cause. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition: 1\) Death
Outcome measures
| Measure |
Abatacept
n=40 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Percentage of Participants Who Died
|
12.5 Percentage of participants
Interval 2.3 to 22.7
|
15.8 Percentage of participants
Interval 0.0 to 32.2
|
SECONDARY outcome
Timeframe: Day 28±3Population: All treated participants
Respiratory failure is defined by the type of resources required as defined by the use of any of these: Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or oxygen delivery by noninvasive positive pressure or high flow nasal cannula. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition: 4\) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities
Outcome measures
| Measure |
Abatacept
n=40 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3
|
75.0 Percentage of participants
Interval 61.6 to 88.4
|
73.7 Percentage of participants
Interval 53.9 to 93.5
|
SECONDARY outcome
Timeframe: Day 28Population: All treated participants
Recovery of pulmonary function is assessed by the percentage of participants returned to room air on day 28 after they were oxygen dependent and dependence on oxygen has been noted to be prolonged even after hospital discharge. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition: 5\) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 8) Not hospitalized, no limitation on activities
Outcome measures
| Measure |
Abatacept
n=40 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Percentage of Participants Returned to Room Air on Day 28
|
70.0 Percentage of participants
Interval 55.8 to 84.2
|
57.9 Percentage of participants
Interval 35.7 to 80.1
|
SECONDARY outcome
Timeframe: From day 1 up to day 28Population: All treated participants
Percentage of participants alive and discharged from the hospital on day 28. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition: 7\) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities
Outcome measures
| Measure |
Abatacept
n=40 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Percentage of Participants Alive and Discharged From the Hospital by Day 28
|
82.5 Percentage of participants
Interval 70.7 to 94.3
|
73.7 Percentage of participants
Interval 53.9 to 93.5
|
SECONDARY outcome
Timeframe: From first dose to 60 days post first dosePopulation: All treated participants
Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life threatening * Requires inpatient hospitalization * Results in persistent or significant disability * Is a congenital anomaly/birth defect * Is an important medical event
Outcome measures
| Measure |
Abatacept
n=40 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events
|
20.0 Percentage of participants
|
31.6 Percentage of participants
|
SECONDARY outcome
Timeframe: From first dose to 60 days post first dosePopulation: All treated participants
Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)
Outcome measures
| Measure |
Abatacept
n=40 Participants
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 Participants
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class
|
7.5 Percentage of participants
|
5.3 Percentage of participants
|
Adverse Events
Abatacept
Serious events: 8 serious events
Other events: 8 other events
Deaths: 7 deaths
Placebo
Serious events: 6 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Abatacept
n=40 participants at risk
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 participants at risk
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
7.5%
3/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
2/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia klebsiella
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pseudomonal sepsis
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
5.0%
2/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Seizure
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.0%
2/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
2/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
4/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.1%
4/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Abatacept
n=40 participants at risk
Abatacept 10 mg/kg IV + Standard of care (SOC)
|
Placebo
n=19 participants at risk
Placebo infusion + Standard of care (SOC)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
2/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
2/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
2/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Mastoid effusion
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
2/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
7.5%
3/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
2/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract candidiasis
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Transaminases increased
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin I increased
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.5%
1/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
1/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
2/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
2/19 • Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER