Trial Outcomes & Findings for Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (NCT NCT04311697)
NCT ID: NCT04311697
Last Updated: 2023-07-24
Results Overview
Participant is Alive and Free of Respiratory Failure (without subsequent relapse over 7 days) determined as no longer requiring acute care or more than low flow oxygen
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
203 participants
Primary outcome timeframe
Day 28
Results posted on
2023-07-24
Participant Flow
Participant milestones
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
67
|
|
Overall Study
COMPLETED
|
85
|
35
|
|
Overall Study
NOT COMPLETED
|
51
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
Baseline characteristics by cohort
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
n=131 Participants
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
n=65 Participants
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 12.61 • n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
62.7 years
STANDARD_DEVIATION 12.11 • n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
61.0 years
STANDARD_DEVIATION 3.4 • n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
15 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
61 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Sex: Female, Male
Male
|
85 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
50 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
135 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
66 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
39 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
105 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
26 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
91 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
0 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
0 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
0 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
1 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
1 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
8 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
1 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
1 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
5 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
15 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Race (NIH/OMB)
White
|
110 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
57 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
167 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
0 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
0 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
1 Participants
n=107 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
4 Participants
n=206 Participants • 5 patients in aviptadil group and 2 patients in placebo group were randomized but not treated.
|
|
Region of Enrollment
United States
|
131 participants
n=99 Participants
|
65 participants
n=107 Participants
|
196 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 28Participant is Alive and Free of Respiratory Failure (without subsequent relapse over 7 days) determined as no longer requiring acute care or more than low flow oxygen
Outcome measures
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
n=131 Participants
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
n=65 Participants
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
|---|---|---|
|
Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)
|
72 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 60Survival probability on logistic regression through day 60
Outcome measures
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
n=131 Participants
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
n=65 Participants
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
|---|---|---|
|
Number of Participants Alive at Day 60
|
85 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Day 60Achievement of score 6-8 on NIAID Ordinal Scale through day 60 The NIAID score is the patient's status on the following 8-point scale:1)Death2)Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO),3)Hospitalized, on non-invasive ventilation or high flow oxygen devices4)Hospitalized, requiring supplemental oxygen5)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 care7)Not hospitalized, limitation on activities and/or requiring home oxygen8)Not hospitalized, no limitations on activities-- a lower NIAID score is a worse outcome.
Outcome measures
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
n=131 Participants
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
n=65 Participants
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
|---|---|---|
|
Number of Participants Achieving a Score of 6-8 on NIAID Ordinal Score Through Day 60
|
76 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: only patients with observations were analyzed
oxygenation index (also known as Respiratory Distress Ratio) as measured by PaO2:FiO2 ratio (Respiratory Distress while on mechanical ventilation). RDR: PaO2:FiO2 represents an intermediate clinical endpoint that is known to be predictive of survival. RDR can only be measured in patients on mechanical ventilation because of its reliance on arterial blood gas measurements that are not routinely collected in non-intubated patients. A higher score indicates a better clinical outcome.
Outcome measures
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
n=65 Participants
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
n=33 Participants
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
|---|---|---|
|
Oxygenation Index as Measured by PaO2:FiO2 Ratio
|
139.2 PaO2:FiO2 ratio
Standard Deviation 77.0
|
116.2 PaO2:FiO2 ratio
Standard Deviation 41.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28Change in IL-6, an inflammatory marker
Outcome measures
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
n=38 Participants
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
n=18 Participants
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
|---|---|---|
|
Change in IL-6
|
19.8 IL-6 picogram/mL
Standard Deviation 39.9
|
23.5 IL-6 picogram/mL
Standard Deviation 39.7
|
Adverse Events
Aviptadil IV in Escalating Doses + Standard of Care
Serious events: 58 serious events
Other events: 102 other events
Deaths: 46 deaths
Placebo + Standard of Care
Serious events: 32 serious events
Other events: 49 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
n=131 participants at risk
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
n=65 participants at risk
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
|---|---|---|
|
Blood and lymphatic system disorders
blood loss anaemia
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
bradycardia
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
cardiac arrest
|
3.8%
5/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
cardio-respiratory arrest
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
cardiogenic shock
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
myocardial infarction
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
pulseless electrical activity
|
3.8%
5/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
tachycardia
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
ventricular tachycardia
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Gastrointestinal disorders
abdominal wall haematoma
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Gastrointestinal disorders
gastric perforation
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Gastrointestinal disorders
upper gastrointestinal haemorrhage
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
General disorders
medical device site haemorrhage
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
General disorders
multiple organ dysfunction syndrome
|
6.1%
8/131 • Number of events 8 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
13.8%
9/65 • Number of events 9 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Hepatobiliary disorders
hepatic failure
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
COVID-19
|
16.8%
22/131 • Number of events 22 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
15.4%
10/65 • Number of events 10 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
diverticulitis
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
klebsiella infection
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
pneumonia escherichia
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
pneumonia infection
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
sepsis
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
septic shock
|
3.8%
5/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
oxygen consumption increased
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
oxygen saturation decreased
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
pulse absent
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Nervous system disorders
brain oedema
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Nervous system disorders
cerebellar infarction
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Nervous system disorders
superior sagittal sinus thrombosis
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Psychiatric disorders
suicidal ideation
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Renal and urinary disorders
acute kidney injury
|
5.3%
7/131 • Number of events 7 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
7.7%
5/65 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Renal and urinary disorders
renal impairment
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
6.2%
4/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
emphysema
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
lung infiltration
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
pneumomediastinum
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
11.5%
15/131 • Number of events 15 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
12.3%
8/65 • Number of events 8 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory fatigue
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
aortic stenosis
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
hypotension
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
hypotensive crisis
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
shock
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
shock haemorrhagic
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
Other adverse events
| Measure |
Aviptadil IV in Escalating Doses + Standard of Care
n=131 participants at risk
Patients will be administered Aviptadil IV in escalating doses of 50 pmol, 100 pmol, 150 pmol/kg/hr
Aviptadil by intravenous infusion + standard of care: Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
Placebo + Standard of Care
n=65 participants at risk
Patients will first be treated with placebo infusion + maximal intensive care
Normal Saline Infusion + standard of care: Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
|
|---|---|---|
|
Blood and lymphatic system disorders
anaemia
|
6.1%
8/131 • Number of events 8 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
6.2%
4/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Blood and lymphatic system disorders
leukocytosis
|
6.1%
8/131 • Number of events 8 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
7.7%
5/65 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
7.7%
5/65 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
atrial fibrillation
|
11.5%
15/131 • Number of events 18 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
bradycardia
|
6.9%
9/131 • Number of events 9 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
cardiac arrest
|
3.8%
5/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
pulseless electrical activity
|
3.8%
5/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
sinus arrest
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
sinus bradycardia
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
sinus tachycardia
|
3.1%
4/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
tachycardia
|
3.8%
5/131 • Number of events 7 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Cardiac disorders
ventricular tachycardia
|
3.1%
4/131 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
7.7%
5/65 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Gastrointestinal disorders
constipation
|
6.9%
9/131 • Number of events 9 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
10.8%
7/65 • Number of events 7 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Gastrointestinal disorders
diarrhoea
|
32.8%
43/131 • Number of events 48 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
General disorders
multiple organ dysfunction syndrome
|
6.9%
9/131 • Number of events 9 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
13.8%
9/65 • Number of events 9 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
General disorders
oedema peripheral
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
General disorders
pyrexia
|
3.8%
5/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
aspergillus infection
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
COVID-19
|
16.8%
22/131 • Number of events 22 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
15.4%
10/65 • Number of events 10 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
cytomegalovirus infection
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
herpes simplex
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
sepsis
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Infections and infestations
septic shock
|
4.6%
6/131 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
6.2%
4/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
4.6%
6/131 • Number of events 7 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Injury, poisoning and procedural complications
mechanical ventilation complication
|
3.1%
4/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
alanine aminotransferase increased
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
6.2%
4/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
aspartate aminotransferase increased
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
base excess increased
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
blood bicarbonate increased
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
blood creatinine increased
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
blood lactic acid increased
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
blood pH increased
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
haematocrit decreased
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
mean cell haemoglobin increased
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
metamyelocyte count increased
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
monocyte count increased
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
myelocyte count increased
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
neutrophil count increased
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
oxygen saturation decreased
|
3.1%
4/131 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
PCO2 decreased
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
PO2 decreased
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
protein total decreased
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
urine output decreased
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Investigations
white blood cell count increased
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
decreased appetite
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
fluid overload
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
12.2%
16/131 • Number of events 16 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
6.2%
4/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
hypernatraemia
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
hypokalaemia
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
6.2%
4/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
hyponatraemia
|
3.8%
5/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
3.8%
5/131 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Nervous system disorders
dizziness
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Nervous system disorders
encephalopathy
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Nervous system disorders
headache
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Nervous system disorders
toxic encephalopathy
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Psychiatric disorders
agitation
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Psychiatric disorders
anxiety
|
4.6%
6/131 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Psychiatric disorders
confusional state
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Psychiatric disorders
depression
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Psychiatric disorders
insomnia
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Psychiatric disorders
restlessness
|
4.6%
6/131 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Renal and urinary disorders
acute kidney injury
|
23.7%
31/131 • Number of events 32 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
20.0%
13/65 • Number of events 14 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Renal and urinary disorders
anuria
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Renal and urinary disorders
azotaemia
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Renal and urinary disorders
renal impairment
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
5.3%
7/131 • Number of events 7 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
6.2%
4/65 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
4.6%
3/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
3.1%
4/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
1.5%
2/131 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
3.1%
4/131 • Number of events 4 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
increased bronchial secretion
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
lung infiltration
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.76%
1/131 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
pneumomediastinum
|
4.6%
6/131 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
7.7%
5/65 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
5.3%
7/131 • Number of events 7 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
9.2%
6/65 • Number of events 8 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
12.2%
16/131 • Number of events 17 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
13.8%
9/65 • Number of events 9 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Respiratory, thoracic and mediastinal disorders
tachypnoea
|
3.8%
5/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Skin and subcutaneous tissue disorders
subcutaneous emphysema
|
3.1%
4/131 • Number of events 5 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 6 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
deep vein thrombosis
|
13.0%
17/131 • Number of events 19 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
13.8%
9/65 • Number of events 10 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
flushing
|
9.9%
13/131 • Number of events 19 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
hypertension
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
1.5%
1/65 • Number of events 1 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
hypotension
|
26.0%
34/131 • Number of events 45 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
21.5%
14/65 • Number of events 19 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
hypotensive crisis
|
0.00%
0/131 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
3.1%
2/65 • Number of events 2 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
|
Vascular disorders
shock
|
2.3%
3/131 • Number of events 3 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
0.00%
0/65 • AEs were collected from administration of informed consent through the subject's hospital discharge. Any ongoing AE was followed through 60 days.
Note: The numbers of patients for the PTs in a SOC may not add up to the number of patients for the SOC because patients with multiple PTs in the same SOC were counted only once. For similar reasons, the sum of the numbers of patients for the SOCs may not be the same as the number of patients with any SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place