Trial Outcomes & Findings for A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II (NCT NCT05055258)
NCT ID: NCT05055258
Last Updated: 2026-05-06
Results Overview
To examine the number of investigator-confirmed attacks whilst on treatment compared to placebo. Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-05-06
Participant Flow
Recruitment Start Date - 06Aug21-27Oct22 First Patient Enrolled - 18Nov21 Long term follow-up planned: No Independent data monitoring committee (IDMC) involvement: No
Screening details- Screening included the screening visit and run-in period. After screening, subjects entered run-in period of upto 8wks.Start of the run-in period was determined by type of HAE therapy being used by the subject at the time of screening. Period 1 or Treatment period (overall period)- Randomized-controlled and double blind 33 subjects assigned treatment: 29 received and included in safety and efficacy analysis; 4 did not receive IMP as study was terminated before 1st dose.
Participant milestones
| Measure |
300 mg KVD824 BID
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
7
|
7
|
|
Overall Study
COMPLETED
|
5
|
4
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
5
|
Reasons for withdrawal
| Measure |
300 mg KVD824 BID
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Overall Study
Trial Termination by Sponsor
|
2
|
2
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II
Baseline characteristics by cohort
| Measure |
300 mg KVD824
n=7 Participants
300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824
n=8 Participants
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824
n=7 Participants
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824
n=7 Participants
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
7 Participants
n=480 Participants
|
26 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
3 Participants
n=24 Participants
|
|
Age, Continuous
|
46.0 years
n=54 Participants
|
44.0 years
n=60 Participants
|
35.0 years
n=114 Participants
|
53.0 years
n=480 Participants
|
47.0 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
3 Participants
n=480 Participants
|
16 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
4 Participants
n=480 Participants
|
13 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
5 Participants
n=480 Participants
|
24 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=480 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=480 Participants
|
2 Participants
n=24 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=54 Participants
|
0 participants
n=60 Participants
|
0 participants
n=114 Participants
|
0 participants
n=480 Participants
|
1 participants
n=24 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=54 Participants
|
1 participants
n=60 Participants
|
0 participants
n=114 Participants
|
0 participants
n=480 Participants
|
2 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=54 Participants
|
4 participants
n=60 Participants
|
1 participants
n=114 Participants
|
2 participants
n=480 Participants
|
8 participants
n=24 Participants
|
|
Region of Enrollment
Czechia
|
0 participants
n=54 Participants
|
1 participants
n=60 Participants
|
1 participants
n=114 Participants
|
0 participants
n=480 Participants
|
2 participants
n=24 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=54 Participants
|
0 participants
n=60 Participants
|
1 participants
n=114 Participants
|
1 participants
n=480 Participants
|
2 participants
n=24 Participants
|
|
Region of Enrollment
North Macedonia
|
1 participants
n=54 Participants
|
0 participants
n=60 Participants
|
0 participants
n=114 Participants
|
1 participants
n=480 Participants
|
2 participants
n=24 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=54 Participants
|
1 participants
n=60 Participants
|
1 participants
n=114 Participants
|
2 participants
n=480 Participants
|
5 participants
n=24 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=54 Participants
|
0 participants
n=60 Participants
|
1 participants
n=114 Participants
|
0 participants
n=480 Participants
|
2 participants
n=24 Participants
|
|
Region of Enrollment
France
|
0 participants
n=54 Participants
|
1 participants
n=60 Participants
|
0 participants
n=114 Participants
|
1 participants
n=480 Participants
|
2 participants
n=24 Participants
|
|
Region of Enrollment
Bulgaria
|
0 participants
n=54 Participants
|
0 participants
n=60 Participants
|
1 participants
n=114 Participants
|
0 participants
n=480 Participants
|
1 participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=54 Participants
|
0 participants
n=60 Participants
|
1 participants
n=114 Participants
|
0 participants
n=480 Participants
|
2 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Negative binomial regression on investigator-confirmed HAE attacks while on treatment (FAS) were evaluated. The primary efficacy results should be interpreted with caution acknowledging that an insufficient number of subjects were randomized and were on study for too short a period to achieve adequate power to detect treatment effects between KVD824 and placebo groups.
To examine the number of investigator-confirmed attacks whilst on treatment compared to placebo. Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Outcome measures
| Measure |
300 mg KVD824 BID
n=7 Participants
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
n=8 Participants
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
n=7 Participants
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
n=7 Participants
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
The Rate of Investigator-confirmed HAE Attacks During the Treatment Period
|
1.476 HAE attacks
Interval 0.786 to 2.774
|
1.072 HAE attacks
Interval 0.534 to 2.152
|
1.566 HAE attacks
Interval 0.814 to 3.012
|
2.380 HAE attacks
Interval 1.282 to 4.418
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Logistic regression on subjects were measured without investigator-confirmed HAE Attacks (FAS).
Logistic regression on subjects were measured without investigator-confirmed HAE Attacks (FAS). Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Outcome measures
| Measure |
300 mg KVD824 BID
n=7 Participants
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
n=8 Participants
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
n=7 Participants
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
n=7 Participants
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Proportion of Subjects Without Investigator-confirmed HAE Attacks During the Treatment Period.
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksA summary of negative binomial regression on investigator-confirmed HAE attacks with conventional treatment is presented for the FAS. Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Outcome measures
| Measure |
300 mg KVD824 BID
n=7 Participants
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
n=8 Participants
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
n=7 Participants
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
n=7 Participants
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Rate of Investigator-confirmed HAE Attacks That Require Conventional Treatment During the Treatment Period.
|
1.003 Est. treated attack rate over 4 weeks
Interval 0.461 to 2.183
|
1.093 Est. treated attack rate over 4 weeks
Interval 0.485 to 2.464
|
1.229 Est. treated attack rate over 4 weeks
Interval 0.554 to 2.728
|
1.635 Est. treated attack rate over 4 weeks
Interval 0.754 to 3.548
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Angioedema Quality of Life (AE-QoL) Total Score scores was measured during treatment period.
AE-QoL is a quality of life questionnaire with a range of 0 (minimum) to 100 (maximum). A total score of 100 indicates worst possible impairment. Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Outcome measures
| Measure |
300 mg KVD824 BID
n=7 Participants
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
n=6 Participants
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
n=6 Participants
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
n=4 Participants
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Angioedema Quality of Life Questionnaire (AE-QoL) Total Score During the Treatment Period (Change From Baseline)
|
-5.46 Scores on a Scale 0-100
Standard Deviation 16.281
|
-15.69 Scores on a Scale 0-100
Standard Deviation 23.097
|
-3.68 Scores on a Scale 0-100
Standard Deviation 16.889
|
0.74 Scores on a Scale 0-100
Standard Deviation 16.398
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A summary of observed values and change from baseline in AECT total score was measured for the FAS. The higher AECT scores indicate a higher level of angioedema control.
AECT is a 4-item patient-reported outcome measure. The total score is from 0 (minimum) to 16 (maximum). A higher score indicates a higher level of angioedema control. Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Outcome measures
| Measure |
300 mg KVD824 BID
n=7 Participants
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
n=6 Participants
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
n=6 Participants
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
n=4 Participants
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Angioedema Control Test (AECT) Score During the Treatment Period (Change From Baseline).
|
2.6 Scores on a Scale 0-16
Standard Deviation 4.93
|
5.5 Scores on a Scale 0-16
Standard Deviation 3.83
|
1.3 Scores on a Scale 0-16
Standard Deviation 6.68
|
-1.5 Scores on a Scale 0-16
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Summary of Logistic Regression on proportion of subjects with AECT Score ≥12 was measured at the End of the Treatment Period (FAS).
AECT is a 4-item patient-reported outcome measure. The total score is from 0 (minimum) to 16 (maximum). A higher score indicates a higher level of angioedema control. Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Outcome measures
| Measure |
300 mg KVD824 BID
n=7 Participants
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
n=8 Participants
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
n=7 Participants
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
n=7 Participants
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Proportion of Subjects With an AECT Score ≥12 at the End of the Treatment Period.
YES
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Proportion of Subjects With an AECT Score ≥12 at the End of the Treatment Period.
NO
|
3 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Proportion of Subjects With an AECT Score ≥12 at the End of the Treatment Period.
MISSING
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
300 mg KVD824 BID
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
600 mg KVD824 BID
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
900 mg KVD824 BID
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo to KVD824 BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
300 mg KVD824 BID
n=7 participants at risk
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
n=8 participants at risk
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
n=7 participants at risk
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
n=7 participants at risk
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
Other adverse events
| Measure |
300 mg KVD824 BID
n=7 participants at risk
One 300 mg KVD824 twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
600 mg KVD824 BID
n=8 participants at risk
Two 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
900 mg KVD824 BID
n=7 participants at risk
Three 300 mg KVD824 tablets twice a day for 12 weeks
KVD824: KVD824 300 mg Modified-Release Tablets
|
Placebo to KVD824 BID
n=7 participants at risk
One, two or three placebo tablets to be taken twice a day for 12 weeks
Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
General disorders
Asthenia
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Investigations
Liver function test abnormal
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Investigations
Liver function test increased
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Investigations
Weight decreased
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Investigations
Weight increased
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
25.0%
2/8 • Number of events 2 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Infections and infestations
COVID-19
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
25.0%
2/8 • Number of events 2 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Infections and infestations
Gastroenteritis
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Infections and infestations
Pharyngitis
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Infections and infestations
Pulpitis dental
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Infections and infestations
Tonsillitis
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Infections and infestations
Viral infection
|
14.3%
1/7 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/8 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Infections and infestations
Viral upper respiratory track infection
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
12.5%
1/8 • Number of events 1 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
0.00%
0/7 • Safety analyses were performed by treatment group using the SAF and were presented during treatment. period
TEAEs in most subjects were mild or moderate in severity. There were no deaths reported in the trial. The trial was terminated due to blinded observation of significant liver enzyme elevations in multiple subjects across dosing groups in the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60