Trial Outcomes & Findings for Brequinar Combined With Dipyridamole in Patients With Mild to Moderate COVID-19 (NCT NCT05166876)
NCT ID: NCT05166876
Last Updated: 2023-11-07
Results Overview
There were no subjects who experienced grade 3 and 4 toxicities and serious adverse events (SAEs) considered by the investigator to be related to the combination, brequinar alone or placebo alone. therefore frequencies of these events could not be compared.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Day 29
Results posted on
2023-11-07
Participant Flow
26 participants were enrolled at 4 medical clinics in India. First participant was enrolled 02/01/2022, last participant completed the study 06/04/2022.
Participant milestones
| Measure |
Brequinar Monotherapy
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Placebo
Placebo matching brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Placebo: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Brequinar-Dipyridamole Combination
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met. All subjects assigned to this arm will also receive dipyridamole 75 mg tablets TID.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
Dipyridamole 75 MG: 75 mg TID for 5 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
13
|
|
Overall Study
COMPLETED
|
6
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Brequinar Monotherapy
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Placebo
Placebo matching brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Placebo: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Brequinar-Dipyridamole Combination
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met. All subjects assigned to this arm will also receive dipyridamole 75 mg tablets TID.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
Dipyridamole 75 MG: 75 mg TID for 5 days
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Brequinar Combined With Dipyridamole in Patients With Mild to Moderate COVID-19
Baseline characteristics by cohort
| Measure |
Brequinar Monotherapy
n=7 Participants
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Placebo
n=6 Participants
Placebo matching brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Placebo: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Brequinar-Dipyridamole Combination
n=13 Participants
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met. All subjects assigned to this arm will also receive dipyridamole 75 mg tablets TID.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
Dipyridamole 75 MG: 75 mg TID for 5 days
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.00 years
STANDARD_DEVIATION 14.05 • n=5 Participants
|
53.50 years
STANDARD_DEVIATION 12.55 • n=7 Participants
|
43.00 years
STANDARD_DEVIATION 14.12 • n=5 Participants
|
41.00 years
STANDARD_DEVIATION 14.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
26 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: No subjects experienced any grade 3 or 4 toxicity (related adverse event) or serious adverse event (SAE), therefore no analyses could be conducted.
There were no subjects who experienced grade 3 and 4 toxicities and serious adverse events (SAEs) considered by the investigator to be related to the combination, brequinar alone or placebo alone. therefore frequencies of these events could not be compared.
Outcome measures
| Measure |
Brequinar Monotherapy
n=7 Participants
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Placebo
n=6 Participants
Placebo matching brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Placebo: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Brequinar-Dipyridamole Combination
n=13 Participants
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met. All subjects assigned to this arm will also receive dipyridamole 75 mg tablets TID.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
Dipyridamole 75 MG: 75 mg TID for 5 days
|
|---|---|---|---|
|
Safety and Tolerability of the Brequinar-dipyridamole Combination in COVID-19 Subjects
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 29Population: There were no subjects with detectable viral load after baseline therefore no analyses could be conducted regarding change in viral load.
There were no subjects with detectable viral load after baseline, therefore no analyses could be conducted regarding change in viral load from baseline of SARS-CoV-2 levels using qPCR SARS-CoV-2 levels through Day 29 and at days 4, 8, 12, 15, 22, and 29
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: There were no subjects with clinically significant symptoms after baseline therefore no analyses could be conducted regarding change from baseline.
There were no subjects who had changes in symptom improvement, therefore no analyses of changes in symptom improvement could be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: No subjects were hospitalized in any of the groups, therefore no analyses could be conducted.
There were no subjects who required hospital admission/re-admission as an in-patient for \>24 hours, therefore no analyses could be conducted for comparative change in percentage of subjects who required hospital admission/readmission for \>24 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: No subjects required medical attended visits in any of the groups, therefore no analyses could be conducted.
There were no subjects requiring medical attended visits, e.g., hospitalization, emergency room visits, Urgent Care/Family Doctor visits, therefore no analyses could be conducted for comparative change in percentage of subjects requiring medical attended visits, e.g., hospitalization, emergency room visits, Urgent Care/Family Doctor visits
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: No subjects required oxygen in any of the groups, therefore no analyses could be conducted.
There were no subjects that required supplemental support such as oxygen, therefore analyses of comparative change in percentage of subjects requiring supplemental support such as oxygen could not be conducted.
Outcome measures
Outcome data not reported
Adverse Events
Brequinar Monotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Brequinar-Dipyridamole Combination
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brequinar Monotherapy
n=7 participants at risk
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Placebo
n=6 participants at risk
Placebo matching brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met.
Placebo: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
|
Brequinar-Dipyridamole Combination
n=13 participants at risk
Brequinar oral capsules will be administered once daily for 5 days using a dose-escalation approach. Planned doses include 50 mg, 100 mg, 150 mg, and 200 mg. Dosing will start at 50 mg and be escalated to the next higher dose if cohort stopping rules are not met. All subjects assigned to this arm will also receive dipyridamole 75 mg tablets TID.
Brequinar Sodium: 50 mg, 100 mg, 150 mg, 200 mg x 5 days
Dipyridamole 75 MG: 75 mg TID for 5 days
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
16.7%
1/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
7.7%
1/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
0.00%
0/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
15.4%
2/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
0.00%
0/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
7.7%
1/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
16.7%
1/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
0.00%
0/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
General disorders
Fatigue
|
0.00%
0/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
16.7%
1/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
7.7%
1/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
Gastrointestinal disorders
Asthenia
|
0.00%
0/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
16.7%
1/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
0.00%
0/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
General disorders
Pyrexia
|
14.3%
1/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
0.00%
0/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
7.7%
1/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
0.00%
0/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
7.7%
1/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
0.00%
0/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
7.7%
1/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
0.00%
0/6 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
7.7%
1/13 • 29 days
Adverse Events (AEs) were collected from the time of first dose of study drug through Day 29. AEs determined by the Investigator to be related to study drug were followed until resolution or until they were considered stable or for at least 30 days after discontinuation of study drug. All AEs recorded on the electronic case report form (eCRF) were coded using the MedDRA dictionary Version 23.1 (or a later version if updated during the study).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place