Trial Outcomes & Findings for Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients (NCT NCT04523181)
NCT ID: NCT04523181
Last Updated: 2023-12-13
Results Overview
Number of Patients Who are Alive and Free of Respiratory Failure (e.g., no need for invasive mechanical ventilation, non invasive ventilation, high flow oxygen, or ECMO) on Day 14.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
14 day
Results posted on
2023-12-13
Participant Flow
The first participant was enrolled on October 15, 2020 and the last participant was enrolled on 08 OCT 2021.
Of 134 enrolled patients, 124 met inclusion criteria and 124 were randomized to treatment.
Participant milestones
| Measure |
Antroquinonol With SOC
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
62
|
|
Overall Study
Treated
|
60
|
62
|
|
Overall Study
COMPLETED
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Antroquinonol With SOC
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Transferred to external facility.
|
1
|
1
|
Baseline Characteristics
Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
Baseline characteristics by cohort
| Measure |
Antroquinonol With SOC
n=62 Participants
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
n=62 Participants
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
n=5 Participants
|
49.5 years
n=7 Participants
|
50.0 years
n=5 Participants
|
|
Age, Customized
≤65 years
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI
|
30.487 kg/m^2
n=5 Participants
|
32.140 kg/m^2
n=7 Participants
|
31.250 kg/m^2
n=5 Participants
|
|
Remdesivir or Other Authorized Treatments for COVID-19 Use
Yes
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Remdesivir or Other Authorized Treatments for COVID-19 Use
No
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 dayPopulation: The Intention-to-treat population (ITT). All randomized patients. Patients will be analyzed according to the treatment to which they were randomized.
Number of Patients Who are Alive and Free of Respiratory Failure (e.g., no need for invasive mechanical ventilation, non invasive ventilation, high flow oxygen, or ECMO) on Day 14.
Outcome measures
| Measure |
Antroquinonol With SOC
n=62 Participants
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
n=62 Participants
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Recover Ratio
Alive and Free of Respiratory Failure
|
47 Participants
|
48 Participants
|
|
Recover Ratio
Respiratory Failure
|
1 Participants
|
0 Participants
|
|
Recover Ratio
Missing
|
14 Participants
|
14 Participants
|
|
Recover Ratio
Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28-dayPopulation: The Intention-to-treat population (ITT). All randomized patients. Patients will be analyzed according to the treatment to which they were randomized.
Time to 2-point improvement from baseline, time to score 2 and lower from baseline and time to score 0 from baseline are measured by WHO COVID-19 Clinical Improvement Ordinal Scale
Outcome measures
| Measure |
Antroquinonol With SOC
n=62 Participants
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
n=62 Participants
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Time to 2-point Improvement, Score 2 or Lower, and Score 0 From Baseline on the WHO COVID-19 Clinical Improvement Ordinal Scale
Time to 2-point Improvement from Baseline
|
7.0 days
Interval 5.0 to 15.0
|
6.0 days
Interval 5.0 to 9.0
|
|
Time to 2-point Improvement, Score 2 or Lower, and Score 0 From Baseline on the WHO COVID-19 Clinical Improvement Ordinal Scale
Time to Score 2 or Lower from Baseline
|
6 days
Interval 4.0 to 10.0
|
6 days
Interval 5.0 to 9.0
|
|
Time to 2-point Improvement, Score 2 or Lower, and Score 0 From Baseline on the WHO COVID-19 Clinical Improvement Ordinal Scale
Time to Score 0 from Baseline
|
29.0 days
Interval 29.0 to 30.0
|
31 days
Interval 30.0 to 42.0
|
SECONDARY outcome
Timeframe: 28 dayPopulation: The Intention-to-treat population (ITT). All randomized patients. Patients will be analyzed according to the treatment to which they were randomized.
Duration of hospitalization is the total number of days the patient is hospitalized during their participation in the study, up to Day 28.
Outcome measures
| Measure |
Antroquinonol With SOC
n=62 Participants
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
n=60 Participants
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Duration of Hospitalization
Overall
|
6.5 days
Standard Deviation 5.54
|
6.4 days
Standard Deviation 5.38
|
|
Duration of Hospitalization
Age ≤65 Years Old
|
6.7 days
Standard Deviation 5.72
|
6.4 days
Standard Deviation 5.44
|
|
Duration of Hospitalization
Age >65 Years Old
|
3.8 days
Standard Deviation 1.10
|
6.8 days
Standard Deviation 5.22
|
|
Duration of Hospitalization
With COVID-19 Treatment at Baseline
|
6.1 days
Standard Deviation 5.71
|
5.1 days
Standard Deviation 3.44
|
|
Duration of Hospitalization
Without COVID-19 Treatment at Baseline
|
6.9 days
Standard Deviation 5.38
|
9.0 days
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: 28 dayPopulation: The Intention-to-treat population (ITT). All randomized patients. Patients will be analyzed according to the treatment to which they were randomized.
measured as study days from start of treatment to first negative SARS CoV 2 PCR test
Outcome measures
| Measure |
Antroquinonol With SOC
n=62 Participants
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
n=62 Participants
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Time to Virological Clearance
|
14.0 days
Interval 6.0 to 15.0
|
15.0 days
Interval 7.0 to 29.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intention-to-treat population (ITT). All randomized patients. Patients will be analyzed according to the treatment to which they were randomized.
Patients with loss of taste or smell from baseline and back to normal during the observation period.
Outcome measures
| Measure |
Antroquinonol With SOC
n=10 Participants
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
n=11 Participants
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Number of Patients Who Recovered From Loss of Taste or Smell
|
10 Participants
|
8 Participants
|
Adverse Events
Antroquinonol With SOC
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo With SOC
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antroquinonol With SOC
n=60 participants at risk
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
n=62 participants at risk
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.7%
1/60 • Number of events 1 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
1.7%
1/60 • Number of events 1 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
1.7%
1/60 • Number of events 1 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
1/60 • Number of events 1 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • Number of events 1 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
Other adverse events
| Measure |
Antroquinonol With SOC
n=60 participants at risk
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
Antroquinonol: double-blind for antroquinonol and Placebo with same out-look and same frequency.
|
Placebo With SOC
n=62 participants at risk
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Placebo: Capsule without active compound
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.0%
9/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
4.8%
3/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
8/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
4.8%
3/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
8/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
2/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
6.5%
4/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
3/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
2/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
6.5%
4/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.3%
2/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Transaminases increased
|
3.3%
2/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Blood bicarbonate decreased
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Blood cholesterol decreased
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Glomerular filtration rate decreased
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Hepatic enzyme increased
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Liver function test increased
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Neutrophil count increased
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Platelet count increased
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
3.2%
2/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Blood pressure increased
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Protein total decreased
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Investigations
White blood cell count increased
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Psychiatric disorders
Anxiety
|
6.7%
4/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Psychiatric disorders
Insomnia
|
6.7%
4/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Skin and subcutaneous tissue disorders
Rah
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
3.2%
2/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Skin and subcutaneous tissue disorders
Umbilical discharge
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Nervous system disorders
Head discomfort
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Nervous system disorders
Paraesthesia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Nervous system disorders
Tremor
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Nervous system disorders
Headache
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
General disorders
Feeling abnormal
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
General disorders
Malaise
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
General disorders
Infusion site inflammation
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
General disorders
Oedema peripheral
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
3.2%
2/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
3.2%
2/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Cardiac disorders
Sinus arrhythmia
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
0.00%
0/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Infections and infestations
Oral candidiasis
|
1.7%
1/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Eye disorders
Dry eye
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/60 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
1.6%
1/62 • 4 Weeks
In Antroquinonol with SOC group, 2 patients were randomized but not treated. All-Cause Mortality assessed for all randomized participants, Serious Adverse Events and Other (Not Including Serious) Adverse Events collected from randomized participants who got treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place