Trial Outcomes & Findings for Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection (NCT NCT04818216)
NCT ID: NCT04818216
Last Updated: 2023-12-26
Results Overview
Measure of NAD+ level in whole blood from treatment beginning to end
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline to 10 days
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
Placebo Group
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
9
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
Baseline characteristics by cohort
| Measure |
Placebo Group
n=13 Participants
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=15 Participants
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
52.31 Years
STANDARD_DEVIATION 8.25 • n=5 Participants
|
52.40 Years
STANDARD_DEVIATION 15.99 • n=7 Participants
|
52.36 Years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 10 daysPopulation: Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug.
Measure of NAD+ level in whole blood from treatment beginning to end
Outcome measures
| Measure |
Placebo Group
n=13 Participants
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=15 Participants
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Change in Whole Blood NAD+ Level
|
-0.02 μg/mL
Standard Deviation 0.02
|
0.06 μg/mL
Standard Deviation .07
|
PRIMARY outcome
Timeframe: Baseline to 10 daysPopulation: Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug.
Safety of NR in hospitalized patients with COVID-19 and AKI (defined as adverse event of Grade 3 or higher). Not every grade 3 event was considered to be serious.
Outcome measures
| Measure |
Placebo Group
n=13 Participants
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=15 Participants
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Number of Participants With Adverse Events of Grade 3 or Higher
|
8 participants
|
12 participants
|
PRIMARY outcome
Timeframe: Baseline to 10 daysPopulation: Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug.
Number occurrences of thrombocytopenia defined as \>25% decline in blood platelet count from baseline.
Outcome measures
| Measure |
Placebo Group
n=13 Participants
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=15 Participants
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Occurrence of Thrombocytopenia
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to 10 daysPopulation: Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug.
To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention
Outcome measures
| Measure |
Placebo Group
n=13 Participants
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=15 Participants
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Change in Area Under the Curve (AUC)
|
17.1 mg/dL x day
Interval 9.3 to 21.4
|
17.9 mg/dL x day
Interval 14.9 to 22.8
|
SECONDARY outcome
Timeframe: 30 days to 90 daysPopulation: Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug.
Number of occurrences of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause.
Outcome measures
| Measure |
Placebo Group
n=13 Participants
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=15 Participants
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Effect of NR on Major Adverse Kidney Events (MAKE)
|
6 Number of MAKE events
|
12 Number of MAKE events
|
SECONDARY outcome
Timeframe: 30 days to 90 daysPopulation: Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. Limited number of participants (n \<5) for whom serum creatinine values (change in estimated Glomerular Filtration Rate or eGFR) were available at 30d and 90d.
Measurement of change in eGFR at 30-90 days post randomization
Outcome measures
| Measure |
Placebo Group
n=3 Participants
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=4 Participants
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Change in Estimated Glomerular Filtration Rate (eGFR)
30-day
|
86.38 mL/min/1.73m^2
Standard Deviation 23.35
|
79.02 mL/min/1.73m^2
Standard Deviation 58.12
|
|
Change in Estimated Glomerular Filtration Rate (eGFR)
90-day
|
112.08 mL/min/1.73m^2
|
129.91 mL/min/1.73m^2
|
SECONDARY outcome
Timeframe: 30 days to 90 daysPopulation: Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. Proteinuria was not routinely assessed in a hospital setting for COVID patients and an additional measurement was not performed due to infectious concerns.
Measurement of change in proteinuria at 30-90 days post randomization
Outcome measures
Outcome data not reported
Adverse Events
Placebo Group
Serious events: 7 serious events
Other events: 6 other events
Deaths: 6 deaths
Nicotinamide Riboside Group
Serious events: 12 serious events
Other events: 10 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Placebo Group
n=13 participants at risk
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=15 participants at risk
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Renal and urinary disorders
Worsening of renal function requiring dialysis
|
23.1%
3/13 • Number of events 3 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
26.7%
4/15 • Number of events 4 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Nervous system disorders
Acute encephalopathy
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Nervous system disorders
Acute-subacute infarcts in right frontal right parasagittal and right occipital regions
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
13.3%
2/15 • Number of events 2 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Nervous system disorders
Ischemic stroke
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Cardiac disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
0.00%
0/15 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
General disorders
Septic shock
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
0.00%
0/15 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
General disorders
Cardiopulmonary arrest secondary to COVID-19
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
0.00%
0/15 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
General disorders
Death
|
46.2%
6/13 • Number of events 6 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
73.3%
11/15 • Number of events 11 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
Other adverse events
| Measure |
Placebo Group
n=13 participants at risk
Placebo capsules will be administered 2 capsules twice daily for 10 days
Placebo: Placebo capsule containing inert ingredient
|
Nicotinamide Riboside Group
n=15 participants at risk
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
|
|---|---|---|
|
Hepatobiliary disorders
Elevated liver enzymes
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
26.7%
4/15 • Number of events 4 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Hepatobiliary disorders
Elevated biliruin
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Infections and infestations
Leukocytosis
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Endocrine disorders
Hyperglycemia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Blood and lymphatic system disorders
Superficial venous thrombosis of the mid right cephalic vein
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
0.00%
0/15 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Blood and lymphatic system disorders
Occlusive deep venous thrombosis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
0.00%
0/15 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Nervous system disorders
Delirium
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
0.00%
0/15 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
|
Gastrointestinal disorders
Oropharyngeal dysphagia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
0.00%
0/15 • Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
|
Additional Information
Dr. Subrata Debnath, Assistant Professor
University of Texas Health San Antonio
Phone: 210-450-8333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place