Trial Outcomes & Findings for Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19 (NCT NCT04676867)
NCT ID: NCT04676867
Last Updated: 2022-12-07
Results Overview
Sustained clinical resolution is defined as occurring when no key COVID-19 related symptom has a score higher than 1 over a 72-hour period (as documented using an electronic patient-reported outcome \[ePRO\] instrument), except for sense of smell and taste where the score should be 0 over a 72-hour period. The time to resolution was taken as the time from randomization until the first day of the last 72-hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" from the Food and Drug Administration (FDA). The symptoms are scored as on a scale of 0 to 3 for 12 of the symptoms where 0 is none and on a scale of 0 to 2 for the two other symptoms where 0 is "as usual". A higher score is a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
227 participants
Primary outcome timeframe
28 days
Results posted on
2022-12-07
Participant Flow
A total of 227 subjects signed informed consent, 225 of whom were randomized to treatment (2 subjects were not randomized). Of these 225 randomized subjects, 17 subjects did not take any study medication (causes: failed screening criteria, lost to follow-up, or withdrew consent) and were excluded from all analyses. A total of 208 subjects (92.5%) entered the trial and received at least one dose of study medication.
Participant milestones
| Measure |
Placebo Tablets
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
56
|
57
|
|
Overall Study
Entered Study and Received at Least 1 Dose of Study Medication
|
53
|
55
|
48
|
52
|
|
Overall Study
COMPLETED
|
53
|
54
|
45
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
11
|
6
|
Reasons for withdrawal
| Measure |
Placebo Tablets
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Overall Study
Screen failure
|
0
|
0
|
6
|
2
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
Baseline characteristics by cohort
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
44.9 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
200 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
202 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
53 participants
n=5 Participants
|
55 participants
n=7 Participants
|
48 participants
n=5 Participants
|
52 participants
n=4 Participants
|
208 participants
n=21 Participants
|
|
Smoking status
Never smoker
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Smoking status
Current smoker
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Smoking status
Former smoker
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 daysSustained clinical resolution is defined as occurring when no key COVID-19 related symptom has a score higher than 1 over a 72-hour period (as documented using an electronic patient-reported outcome \[ePRO\] instrument), except for sense of smell and taste where the score should be 0 over a 72-hour period. The time to resolution was taken as the time from randomization until the first day of the last 72-hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" from the Food and Drug Administration (FDA). The symptoms are scored as on a scale of 0 to 3 for 12 of the symptoms where 0 is none and on a scale of 0 to 2 for the two other symptoms where 0 is "as usual". A higher score is a worse outcome.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Time to Sustained Clinical Resolution of Symptoms of COVID-19 (Excluding Cough, Sense of Smell and Taste) in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib
|
9.0 days
Interval 8.0 to 14.0
|
9.0 days
Interval 8.0 to 10.0
|
9.5 days
Interval 8.0 to 14.0
|
10.0 days
Interval 9.0 to 11.0
|
SECONDARY outcome
Timeframe: Screening/Baseline (Day -2 to Day -1), Day 3, Day 5, Day 10, and Day 28/End of Study (EOS)Log10 viral load, as assessed using the saliva, was summarized by treatment group using descriptive statistics (N, mean, median, standard deviation, minimum, and maximum) for each visit as well as for changes from baseline where an 80% CI were also presented. A repeated ANCOVA model was used for the data shown below, showing the mean changes from baseline to study visits (Day 3, Day 5, Day 10, and Day 28/EOS) in log10 viral load including treatment groups by study visit interaction, baseline value of log10 viral load and baseline value of log10 viral load by study visit interaction.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Change From Baseline in log10 Viral Load (Saliva)
Day 3
|
-0.77 log10 viral titers
Interval -1.04 to -0.49
|
-0.79 log10 viral titers
Interval -1.04 to -0.54
|
-0.61 log10 viral titers
Interval -0.89 to -0.32
|
-0.79 log10 viral titers
Interval -1.07 to -0.51
|
|
Change From Baseline in log10 Viral Load (Saliva)
Day 5
|
-1.45 log10 viral titers
Interval -1.72 to -1.18
|
-1.50 log10 viral titers
Interval -1.76 to -1.25
|
-1.45 log10 viral titers
Interval -1.73 to -1.17
|
-1.27 log10 viral titers
Interval -1.55 to -0.99
|
|
Change From Baseline in log10 Viral Load (Saliva)
Day 10
|
-3.43 log10 viral titers
Interval -3.79 to -3.08
|
-3.24 log10 viral titers
Interval -3.55 to -2.92
|
-3.01 log10 viral titers
Interval -3.38 to -2.65
|
-3.23 log10 viral titers
Interval -3.61 to -2.85
|
|
Change From Baseline in log10 Viral Load (Saliva)
Day 28/End of Study
|
-5.16 log10 viral titers
Interval -5.4 to -4.91
|
-4.96 log10 viral titers
Interval -5.2 to -4.72
|
-5.30 log10 viral titers
Interval -5.57 to -5.03
|
-5.16 log10 viral titers
Interval -5.42 to -4.9
|
SECONDARY outcome
Timeframe: Screening/Baseline (Day -2 to Day -1), Day 3, Day 5, Day 10, and Day 28/End of Study (EOS)Log10 viral load, as assessed using the nasal swab, was summarized by treatment group using descriptive statistics (N, mean, median, standard deviation, minimum, and maximum) for each visit as well as for changes from baseline where an 80% CI were also presented. A repeated ANCOVA model was used for the data shown below, showing the mean changes from baseline to study visits (Day 3, Day 5, Day 10, and Day 28/EOS) in log10 viral load including treatment groups by study visit interaction, baseline value of log10 viral load and baseline value of log10 viral load by study visit interaction.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Change From Baseline in log10 Viral Load (Nasal Swab)
Day 3
|
-0.94 log10 viral titers
Interval -1.18 to -0.71
|
-1.17 log10 viral titers
Interval -1.39 to -0.94
|
-0.84 log10 viral titers
Interval -1.09 to -0.6
|
-0.92 log10 viral titers
Interval -1.17 to -0.68
|
|
Change From Baseline in log10 Viral Load (Nasal Swab)
Day 5
|
-1.87 log10 viral titers
Interval -2.15 to -1.6
|
-2.25 log10 viral titers
Interval -2.53 to -1.98
|
-1.47 log10 viral titers
Interval -1.76 to -1.17
|
-2.00 log10 viral titers
Interval -2.29 to -1.71
|
|
Change From Baseline in log10 Viral Load (Nasal Swab)
Day 10
|
-4.76 log10 viral titers
Interval -5.08 to -4.45
|
-4.42 log10 viral titers
Interval -4.72 to -4.11
|
-3.87 log10 viral titers
Interval -4.22 to -3.52
|
-4.23 log10 viral titers
Interval -4.59 to -3.87
|
|
Change From Baseline in log10 Viral Load (Nasal Swab)
Day 28/End of Study
|
-6.24 log10 viral titers
Interval -6.32 to -6.15
|
-6.29 log10 viral titers
Interval -6.38 to -6.21
|
-6.26 log10 viral titers
Interval -6.36 to -6.17
|
-6.34 log10 viral titers
Interval -6.43 to -6.25
|
SECONDARY outcome
Timeframe: 28 daysSustained clinical resolution is defined as occurring when no key COVID-19 related symptom has a score higher than 1 over a 72-hour period (as documented using an electronic patient-reported outcome \[ePRO\] instrument). The time to resolution was taken as the time from randomization until the first day of the last 72-hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" from the Food and Drug Administration (FDA). The symptoms are scored as on a scale of 0 to 3 for 12 of the symptoms where 0 is none and on a scale of 0 to 2 for the two other symptoms where 0 is "as usual". A higher score is a worse outcome.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Time to Sustained Complete Clinical Resolution of Symptoms in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib
|
28.0 days
Interval 16.0 to 28.0
|
28.0 days
Interval 15.0 to 28.0
|
28.0 days
Interval 28.0 to 29.0
|
28.0 days
Interval 28.0 to 28.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Two subjects were deleted from this analysis as the samples were deemed unreliable by the study site. One subject had no saliva samples analyzed.
Viral clearance based on polymerase chain reaction (PCR) test for Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) using nasal swab and saliva samples was performed on the intention-to-treat (ITT) population. Viral clearance was summarized by treatment group using Kaplan-Meier methods. Median and associated 80% confidence interval (CI) was presented. The number and percentage of patients who did not show viral clearance, did show viral clearance, and patients censored were presented.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=54 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=50 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Viral Clearance Using Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR)
Viral Clearance (saliva) · Yes
|
12 Participants
|
10 Participants
|
9 Participants
|
14 Participants
|
|
Viral Clearance Using Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR)
Viral Clearance (saliva) · No
|
41 Participants
|
44 Participants
|
39 Participants
|
36 Participants
|
|
Viral Clearance Using Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR)
Viral Clearance (nasal swab) · Yes
|
25 Participants
|
22 Participants
|
12 Participants
|
14 Participants
|
|
Viral Clearance Using Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR)
Viral Clearance (nasal swab) · No
|
28 Participants
|
32 Participants
|
36 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 28 daysComplete clinical resolution is defined as occurring when no key COVID-19 related symptom (excluding cough, sense of smell and taste) has a score higher than 0 over a 72-hour period. The time to resolution was taken as the time from randomization until the first day of the last 72 hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" was used. The symptoms are scored as on a scale of 0 to 3 for 12 of the symptoms where 0 is none and on a scale of 0 to 2 for the two other symptoms where 0 is "as usual". A higher score is a worse outcome.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Time to Complete Clinical Resolution (Excluding Cough, Sense of Smell and Taste) Defined in the Same Way as the Primary Endpoint, But Considering That All Symptoms Must Resolve to a Score of 0 for 72 Hours
|
28.0 days
Interval 28.0 to 29.0
|
28.0 days
Interval 28.0 to 28.0
|
28.0 days
Interval 28.0 to 29.0
|
28.0 days
Interval 28.0 to 29.0
|
SECONDARY outcome
Timeframe: 28 daysSustained clinical resolution is defined as occurring when no key COVID-19 related symptom has a score higher than 0 over a 72-hour period. The time to resolution was taken as the time from randomization until the first day of the last 72 hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" was used. The symptoms are scored as on a scale of 0 to 3 for 12 of the symptoms where 0 is none and on a scale of 0 to 2 for the two other symptoms where 0 is "as usual". A higher score is a worse outcome. Resolution must have occurred within 28 days. Time of resolution of 29 days was imputed in censored subjects.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Time to Complete Clinical Resolution
|
29.0 days
Interval 28.0 to 29.0
|
28.0 days
Interval 28.0 to 29.0
|
29.0 days
Interval 28.0 to 29.0
|
28.5 days
Interval 28.0 to 29.0
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 14 (follow-up visit 1), and Day 28 (end of study / follow-up visit 2)Population: The number of subjects is different at baseline and at post-baseline visits. The difference in means is therefore not the same as the mean of the differences. The analysis has been conducted on the mean of the differences and the analysis of the change from baseline to Day X is based on subjects who had data at both baseline and Day X visits.
COVID-19 total symptom severity score was summarized by treatment group using descriptive statistics (N, mean, median, standard deviation, minimum, and maximum) for each visit as well as for changes from baseline where an 80% confidence interval (CI) was also presented. Mean changes from baseline were analyzed using a repeated measures ANCOVA model. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" from the Food and Drug Administration (FDA) document "Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Guidance for Industry". Symptoms are scored as on a scale of 0 to 3 for 12 the symptoms and on a scale of 0 to 2 for two symptoms. The sum of all 14 symptom scores is reported, where 0 is the minimum and 40 is the maximum. A higher score is a worse outcome.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Baseline
|
10.70 score on a scale
Standard Deviation 4.98
|
11.11 score on a scale
Standard Deviation 4.34
|
10.88 score on a scale
Standard Deviation 4.63
|
9.02 score on a scale
Standard Deviation 3.92
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 2
|
10.30 score on a scale
Standard Deviation 5.35
|
10.76 score on a scale
Standard Deviation 4.58
|
11.55 score on a scale
Standard Deviation 4.29
|
11.39 score on a scale
Standard Deviation 5.06
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 2
|
-0.40 score on a scale
Standard Deviation 3.85
|
-0.39 score on a scale
Standard Deviation 3.52
|
0.68 score on a scale
Standard Deviation 3.65
|
2.35 score on a scale
Standard Deviation 3.90
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 3
|
8.85 score on a scale
Standard Deviation 4.79
|
9.42 score on a scale
Standard Deviation 4.53
|
10.57 score on a scale
Standard Deviation 5.04
|
10.12 score on a scale
Standard Deviation 5.40
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 3
|
-1.85 score on a scale
Standard Deviation 3.78
|
-1.69 score on a scale
Standard Deviation 3.80
|
-0.38 score on a scale
Standard Deviation 4.46
|
1.08 score on a scale
Standard Deviation 4.71
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 4
|
8.24 score on a scale
Standard Deviation 5.13
|
9.60 score on a scale
Standard Deviation 5.09
|
10.75 score on a scale
Standard Deviation 5.87
|
9.34 score on a scale
Standard Deviation 5.39
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 4
|
-2.54 score on a scale
Standard Deviation 5.04
|
-1.55 score on a scale
Standard Deviation 4.73
|
-0.13 score on a scale
Standard Deviation 5.27
|
0.23 score on a scale
Standard Deviation 5.03
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 5
|
7.90 score on a scale
Standard Deviation 4.97
|
8.89 score on a scale
Standard Deviation 5.56
|
9.29 score on a scale
Standard Deviation 4.78
|
8.36 score on a scale
Standard Deviation 4.50
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 5
|
-2.79 score on a scale
Standard Deviation 4.64
|
-2.26 score on a scale
Standard Deviation 4.98
|
-1.58 score on a scale
Standard Deviation 6.03
|
-0.56 score on a scale
Standard Deviation 4.47
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 6
|
6.98 score on a scale
Standard Deviation 5.09
|
7.94 score on a scale
Standard Deviation 5.44
|
8.09 score on a scale
Standard Deviation 4.86
|
8.24 score on a scale
Standard Deviation 6.23
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 6
|
-3.67 score on a scale
Standard Deviation 5.57
|
-3.23 score on a scale
Standard Deviation 5.32
|
-2.44 score on a scale
Standard Deviation 5.56
|
-0.71 score on a scale
Standard Deviation 5.61
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 7
|
6.0 score on a scale
Standard Deviation 5.5
|
5.75 score on a scale
Standard Deviation 3.94
|
8.39 score on a scale
Standard Deviation 6.49
|
6.91 score on a scale
Standard Deviation 4.57
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 7
|
-4.65 score on a scale
Standard Deviation 5.77
|
-5.29 score on a scale
Standard Deviation 4.85
|
-2.24 score on a scale
Standard Deviation 7.20
|
-2.02 score on a scale
Standard Deviation 4.58
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 8
|
5.06 score on a scale
Standard Deviation 4.14
|
5.82 score on a scale
Standard Deviation 4.13
|
7.02 score on a scale
Standard Deviation 6.25
|
5.50 score on a scale
Standard Deviation 4.03
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 8
|
-5.48 score on a scale
Standard Deviation 5.34
|
-5.38 score on a scale
Standard Deviation 4.76
|
-3.64 score on a scale
Standard Deviation 6.88
|
-3.48 score on a scale
Standard Deviation 4.18
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 9
|
4.44 score on a scale
Standard Deviation 3.76
|
5.22 score on a scale
Standard Deviation 4.34
|
6.86 score on a scale
Standard Deviation 6.45
|
4.90 score on a scale
Standard Deviation 2.80
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 9
|
-6.10 score on a scale
Standard Deviation 5.88
|
-6.20 score on a scale
Standard Deviation 4.75
|
-4.00 score on a scale
Standard Deviation 7.58
|
-3.95 score on a scale
Standard Deviation 4.39
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Day 10
|
3.90 score on a scale
Standard Deviation 3.62
|
4.37 score on a scale
Standard Deviation 3.79
|
5.85 score on a scale
Standard Deviation 6.67
|
4.00 score on a scale
Standard Deviation 2.96
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to Day 10
|
-6.67 score on a scale
Standard Deviation 5.41
|
-6.96 score on a scale
Standard Deviation 4.25
|
-4.59 score on a scale
Standard Deviation 7.56
|
-4.77 score on a scale
Standard Deviation 4.36
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Follow-up visit 1 (Day 14)
|
3.22 score on a scale
Standard Deviation 3.72
|
3.39 score on a scale
Standard Deviation 3.23
|
4.23 score on a scale
Standard Deviation 6.19
|
3.40 score on a scale
Standard Deviation 3.58
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to follow-up visit 1
|
-7.42 score on a scale
Standard Deviation 5.74
|
-7.90 score on a scale
Standard Deviation 4.35
|
-6.59 score on a scale
Standard Deviation 7.24
|
5.21 score on a scale
Standard Deviation 4.95
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Follow-up visit 2 (Day 28/End of Study)
|
1.84 score on a scale
Standard Deviation 2.49
|
2.23 score on a scale
Standard Deviation 2.85
|
2.89 score on a scale
Standard Deviation 6.20
|
1.75 score on a scale
Standard Deviation 2.05
|
|
Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points
Change from baseline to follow-up visit 2
|
-8.96 score on a scale
Standard Deviation 5.14
|
-9.02 score on a scale
Standard Deviation 4.26
|
-7.78 score on a scale
Standard Deviation 7.12
|
-7.17 score on a scale
Standard Deviation 4.74
|
SECONDARY outcome
Timeframe: Screening (Day -2 to Day -1), Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28Population: Not all subjects completed the trial. World Health Organization Clinical Outcome Scores were not collected for withdrawn subjects beyond their withdrawal date.
The number and percentage of patients for each WHO clinical outcome score was summarized. Scores were compared using the Mann-Whitney-Wilcoxon test. This scale is called the "WHO Clinical Outcome Scale". It is scored from 0 to 9 where 9 is the most severe disease presentation. A higher score is a worse outcome.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 2
|
11 Participants
|
18 Participants
|
8 Participants
|
11 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 0
|
3 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 1
|
29 Participants
|
27 Participants
|
19 Participants
|
18 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 2
|
19 Participants
|
20 Participants
|
22 Participants
|
31 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 3
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 4
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
End of Treatment (Day 10) · WHO Clinical Outcome Scale Score 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 0
|
10 Participants
|
14 Participants
|
12 Participants
|
13 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 1
|
31 Participants
|
21 Participants
|
23 Participants
|
24 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 1
|
18 Participants
|
15 Participants
|
19 Participants
|
23 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 2
|
35 Participants
|
40 Participants
|
29 Participants
|
29 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Screening · WHO Clinical Outcome Scale Score 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 1
|
15 Participants
|
13 Participants
|
17 Participants
|
18 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 2
|
38 Participants
|
42 Participants
|
31 Participants
|
34 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 1 · WHO Clinical Outcome Scale Score 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 1
|
18 Participants
|
16 Participants
|
15 Participants
|
19 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 2
|
35 Participants
|
38 Participants
|
32 Participants
|
25 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 3 · WHO Clinical Outcome Scale Score 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 1
|
17 Participants
|
21 Participants
|
12 Participants
|
19 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 2
|
34 Participants
|
31 Participants
|
29 Participants
|
27 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Day 5 · WHO Clinical Outcome Scale Score 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 7
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 1 (Day 14) · WHO Clinical Outcome Scale Score 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 0
|
28 Participants
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 1
|
20 Participants
|
21 Participants
|
21 Participants
|
24 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 2
|
5 Participants
|
12 Participants
|
5 Participants
|
8 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28
Follow-up visit 2 (Day 28/End Of Study) · WHO Clinical Outcome Scale Score 8
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28The analysis of this endpoint was performed on the intention-to-treat (ITT) population. The percentage of patients who were hospitalized was compared using a binary logistic regression analysis. The model included only the treatment group. The results were presented as odds ratios, with associated 80% CIs and p-value.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Rate of Hospitalization Through Day 28
Yes, hospitalized
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Rate of Hospitalization Through Day 28
No, not hospitalized
|
51 Participants
|
51 Participants
|
45 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28The analysis of this endpoint was performed on the intention-to-treat (ITT) population. The number and percentage of patients who progressed to oxygen therapy was presented. The percentage of patients who had progressed to oxygen therapy was compared using a binary logistic regression analysis. The model included only the treatment group. The results were presented as odds ratios, with associated 80% confidence intervals (CIs) and p-value.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Rate of Progression to Oxygen Therapy Through Day 28
Yes, progressed to oxygen therapy
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Rate of Progression to Oxygen Therapy Through Day 28
No, did not progress to oxygen therapy
|
52 Participants
|
51 Participants
|
46 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: The type of oxygen therapy received was measured for all participants in the intent-to-treat (ITT) population; however, the data presented here reflects an analysis performed only on those subjects from the ITT population who received oxygen therapy.
The analysis of this endpoint was performed on the intention-to-treat (ITT) population and only on those who received oxygen therapy. The number and percentage of patients who received different types of oxygen therapy was presented using descriptive statistics.
Outcome measures
| Measure |
Placebo Tablets
n=1 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=4 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=2 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=1 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Type of Oxygen Therapy Received Through Day 28
Supplemental oxygen
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Type of Oxygen Therapy Received Through Day 28
Mechanical ventilation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: The duration of hospitalization was measured for all participants in the intent-to-treat (ITT) population; however, the mean length of hospitalization for each arm presented here reflects an analysis performed on only the hospitalized subjects from the ITT population.
The duration of hospitalization was performed on the intention-to-treat (ITT) population in subjects who were hospitalized. Duration of hospitalization was summarized by treatment group using descriptive statistics (N, mean, median, standard deviation, Q1, Q3, minimum, and maximum). An ANOVA model was performed to analyze the difference between treatment groups. The model included only the treatment group. Contrasts under this model allowed for the comparisons across treatment groups. The results were presented as mean treatment difference with associated 80% confidence interval (CI) and p-value.
Outcome measures
| Measure |
Placebo Tablets
n=2 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=4 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=3 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=1 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Duration of Hospitalization
|
3.0 days
Standard Deviation 0.0
|
5.75 days
Standard Deviation 5.19
|
8.67 days
Standard Deviation 12.42
|
3.0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1 to Day 28The analysis of this endpoint was performed on the intention-to-treat (ITT) population. The number and percentage of patients who died was presented. The percentage of patients who died was compared using a binary logistic regression. The model included only the treatment group. Contrasts under this model allowed for the comparisons across treatment groups. The results were presented as odds ratios, with associated 80% CIs and p-values.
Outcome measures
| Measure |
Placebo Tablets
n=53 Participants
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 Participants
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 Participants
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 Participants
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Mortality Rate by Day 28
No, did not die
|
53 Participants
|
55 Participants
|
47 Participants
|
52 Participants
|
|
Mortality Rate by Day 28
Yes, died
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Placebo Tablets
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
900 mg Dose
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
1800 mg Dose
Serious events: 4 serious events
Other events: 33 other events
Deaths: 1 deaths
3600 mg Dose
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Tablets
n=53 participants at risk
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 participants at risk
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 participants at risk
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 participants at risk
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.00%
0/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
2.1%
1/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.00%
0/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
2.1%
1/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
3.6%
2/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
1.9%
1/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
1.8%
1/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.8%
2/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
5.5%
3/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
2.1%
1/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rash maculopapular
|
0.00%
0/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
2.1%
1/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
1.9%
1/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
1.8%
1/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
Other adverse events
| Measure |
Placebo Tablets
n=53 participants at risk
Participants received twelve dalcetrapib placebo tablets orally daily for 10 days.
Placebo: Dalcetrapib matching placebo tablets
|
900 mg Dose
n=55 participants at risk
Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
1800 mg Dose
n=48 participants at risk
Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
3600 mg Dose
n=52 participants at risk
Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days
Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
18.9%
10/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
25.5%
14/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
29.2%
14/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
57.7%
30/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Feces soft
|
3.8%
2/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
1.8%
1/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
8.3%
4/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
3.8%
2/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
8.3%
4/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
1.9%
1/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
9.4%
5/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
10.9%
6/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
12.5%
6/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
23.1%
12/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
3.6%
2/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
6.2%
3/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
1.9%
1/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Investigations
Laboratory test abnormal
|
13.2%
7/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
9.1%
5/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
10.4%
5/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
7.7%
4/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.8%
2/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
7.3%
4/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
4.2%
2/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
0.00%
0/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
3/53 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
7.3%
4/55 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
10.4%
5/48 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
5.8%
3/52 • Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place