Trial Outcomes & Findings for Effectiveness of CRD-740 in Heart Failure (NCT NCT05409183)
NCT ID: NCT05409183
Last Updated: 2024-12-19
Results Overview
Efficacy: To assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in subjects with CHFrEF.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
CRD-740
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks.
CRD-740: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
Placebo
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.
Placebo: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
|---|---|---|
|
Period 1
STARTED
|
40
|
20
|
|
Period 1
COMPLETED
|
40
|
20
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
40
|
20
|
|
Period 2
COMPLETED
|
38
|
19
|
|
Period 2
NOT COMPLETED
|
2
|
1
|
|
Period 3
STARTED
|
38
|
19
|
|
Period 3
COMPLETED
|
36
|
19
|
|
Period 3
NOT COMPLETED
|
2
|
0
|
|
Complete Study
STARTED
|
40
|
20
|
|
Complete Study
COMPLETED
|
36
|
18
|
|
Complete Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
CRD-740
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks.
CRD-740: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
Placebo
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.
Placebo: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
|---|---|---|
|
Complete Study
Adverse Event
|
1
|
2
|
|
Complete Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Female population only
Baseline characteristics by cohort
| Measure |
CRD-740
n=40 Participants
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks.
CRD-740: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
Placebo
n=20 Participants
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.
Placebo: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=40 Participants
|
9 Participants
n=20 Participants
|
26 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=40 Participants
|
11 Participants
n=20 Participants
|
34 Participants
n=60 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 12.70 • n=40 Participants
|
65.6 years
STANDARD_DEVIATION 13.16 • n=20 Participants
|
67.4 years
STANDARD_DEVIATION 12.81 • n=60 Participants
|
|
Age, Customized
Median Age
|
70.5 years
n=40 Participants
|
66.0 years
n=20 Participants
|
69.0 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=40 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=40 Participants
|
16 Participants
n=20 Participants
|
51 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=40 Participants
|
18 Participants
n=20 Participants
|
54 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=40 Participants
|
4 Participants
n=20 Participants
|
13 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=40 Participants
|
15 Participants
n=20 Participants
|
44 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=40 Participants
|
13 participants
n=20 Participants
|
40 participants
n=60 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=40 Participants
|
4 participants
n=20 Participants
|
12 participants
n=60 Participants
|
|
Region of Enrollment
Israel
|
5 participants
n=40 Participants
|
3 participants
n=20 Participants
|
8 participants
n=60 Participants
|
|
Mean Height (cm) at Baseline
|
175.6 cm
STANDARD_DEVIATION 10.20 • n=40 Participants
|
172.5 cm
STANDARD_DEVIATION 10.65 • n=20 Participants
|
174.6 cm
STANDARD_DEVIATION 10.36 • n=60 Participants
|
|
Median Height (cm) at Baseline
|
175.0 cm
n=40 Participants
|
170.8 cm
n=20 Participants
|
173.4 cm
n=60 Participants
|
|
Reproductive System Findings Test (Female only), n (%)
Childbearing Potential
|
2 Participants
n=5 Participants • Female population only
|
0 Participants
n=4 Participants • Female population only
|
2 Participants
n=9 Participants • Female population only
|
|
Reproductive System Findings Test (Female only), n (%)
Menopause Status
|
3 Participants
n=5 Participants • Female population only
|
4 Participants
n=4 Participants • Female population only
|
7 Participants
n=9 Participants • Female population only
|
|
Mean Weight (kg) at Baseline
|
97.27 kg
STANDARD_DEVIATION 37.582 • n=40 Participants
|
84.07 kg
STANDARD_DEVIATION 16.932 • n=20 Participants
|
92.87 kg
STANDARD_DEVIATION 32.639 • n=60 Participants
|
|
Median Weight (kg) at Baseline
|
87.65 kg
n=40 Participants
|
81.00 kg
n=20 Participants
|
85.55 kg
n=60 Participants
|
|
Mean Body Mass Index (kg/m2) at Baseline
|
31.41 body weight (kg)/ height (m2)
STANDARD_DEVIATION 11.483 • n=40 Participants
|
28.38 body weight (kg)/ height (m2)
STANDARD_DEVIATION 5.953 • n=20 Participants
|
30.40 body weight (kg)/ height (m2)
STANDARD_DEVIATION 10.032 • n=60 Participants
|
|
Median Body Mass Index (kg/m2) at Baseline
|
28.92 body weight (kg)/ height (m2)
n=40 Participants
|
26.72 body weight (kg)/ height (m2)
n=20 Participants
|
27.89 body weight (kg)/ height (m2)
n=60 Participants
|
|
Echocardiogram performed during screening
Yes
|
40 Participants
n=40 Participants
|
20 Participants
n=20 Participants
|
60 Participants
n=60 Participants
|
|
Echocardiogram performed during screening
No
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
EF group
EF ≤ 40%
|
40 Participants
n=40 Participants
|
20 Participants
n=20 Participants
|
60 Participants
n=60 Participants
|
|
EF group
EF > 40%
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Mean EF (%) for rEF (≤40%) subjects
|
29.16 percent
STANDARD_DEVIATION 7.191 • n=40 Participants
|
26.91 percent
STANDARD_DEVIATION 6.181 • n=20 Participants
|
28.41 percent
STANDARD_DEVIATION 6.901 • n=60 Participants
|
|
Median EF (%) for rEF (≤40%) subjects
|
26.50 percent
n=40 Participants
|
25.00 percent
n=20 Participants
|
25.00 percent
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: The modified Intention to Treat (mITT) Population will consist of all randomized subjects who received at least one dose of CRD-740 or placebo. Subjects will be analyzed according to their randomized treatment, regardless of actual treatment received, treatment compliance, or treatment duration.
Efficacy: To assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in subjects with CHFrEF.
Outcome measures
| Measure |
CRD-740
n=30 Participants
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks.
CRD-740: Tablets administered orally.
|
Placebo
n=15 Participants
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.
Placebo: Tablets administered orally.
|
|---|---|---|
|
Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at Week 4.
|
19.139 AUC 0-6hr (hr*nmol/L)
Standard Deviation 26.9007
|
-8.822 AUC 0-6hr (hr*nmol/L)
Standard Deviation 31.3357
|
Adverse Events
Period 1: CRD-740
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Period 1: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Period 2: CRD-740
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 2: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Period 3: CRD-740
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 3: Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Overall CRD-740
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Overall Placebo
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: CRD-740
n=40 participants at risk
CRD-740 10 mg was administered BID to randomly assigned participants in this period from Day 1 through Day 14.
|
Period 1: Placebo
n=20 participants at risk
CRD-740 10 mg matching placebo was administered BID to randomly assigned participants in this period from Day 1 through Day 14.
|
Period 2: CRD-740
n=38 participants at risk
CRD-740 25 mg was administered BID to randomly assigned participants in this period from Day 15 through Day 28.
|
Period 2: Placebo
n=19 participants at risk
CRD-740 25 mg matching placebo was administered BID to randomly assigned participants in this period from Day 15 through Day 28.
|
Period 3: CRD-740
n=36 participants at risk
CRD-740 25 mg was administered BID to randomly assigned participants in this period from Day 29 through Day 84.
|
Period 3: Placebo
n=19 participants at risk
CRD-740 25 mg matching placebo was administered BID to randomly assigned participants in this period from Day 29 through Day 84.
|
Overall CRD-740
n=40 participants at risk
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks plus a 4-week follow-up period.
CRD-740: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
Overall Placebo
n=20 participants at risk
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks plus a 4-week follow-up period.
Placebo: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.3%
1/19 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.6%
1/38 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Infections and infestations
Influenza
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
Other adverse events
| Measure |
Period 1: CRD-740
n=40 participants at risk
CRD-740 10 mg was administered BID to randomly assigned participants in this period from Day 1 through Day 14.
|
Period 1: Placebo
n=20 participants at risk
CRD-740 10 mg matching placebo was administered BID to randomly assigned participants in this period from Day 1 through Day 14.
|
Period 2: CRD-740
n=38 participants at risk
CRD-740 25 mg was administered BID to randomly assigned participants in this period from Day 15 through Day 28.
|
Period 2: Placebo
n=19 participants at risk
CRD-740 25 mg matching placebo was administered BID to randomly assigned participants in this period from Day 15 through Day 28.
|
Period 3: CRD-740
n=36 participants at risk
CRD-740 25 mg was administered BID to randomly assigned participants in this period from Day 29 through Day 84.
|
Period 3: Placebo
n=19 participants at risk
CRD-740 25 mg matching placebo was administered BID to randomly assigned participants in this period from Day 29 through Day 84.
|
Overall CRD-740
n=40 participants at risk
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks plus a 4-week follow-up period.
CRD-740: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
Overall Placebo
n=20 participants at risk
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks plus a 4-week follow-up period.
Placebo: Tablets administered orally.
Part B of the study was not conducted in favor of redesigned new studies.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.6%
1/38 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Eye disorders
Scleritis
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.3%
1/19 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.8%
1/36 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.6%
1/38 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.6%
1/38 • Number of events 2 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.8%
1/36 • Number of events 2 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 4 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.8%
1/36 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.3%
1/19 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/36 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
5.0%
1/20 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/40 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/38 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.8%
1/36 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/19 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
2.5%
1/40 • Number of events 1 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
0.00%
0/20 • Through week 12 plus a 4-week follow-up period.
For Part A, the primary safety analysis was performed by reporting the exposure-adjusted incidence rates in subject-years for AEs and SAEs defined as the number of subjects with that particular AE or SAE within an SOC or PT during the relevant period divided by the sum of the at-risk times.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place