Trial Outcomes & Findings for RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) (NCT NCT04620733)
NCT ID: NCT04620733
Last Updated: 2024-09-05
Results Overview
Percentages were rounded-off.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
193 participants
Primary outcome timeframe
Month 12
Results posted on
2024-09-05
Participant Flow
Participants were enrolled at study sites in the Asia Pacific, Europe, Latin America, and North America.
360 participants were screened.
Participant milestones
| Measure |
Placebo
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
128
|
|
Overall Study
COMPLETED
|
57
|
117
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
1
|
|
Overall Study
Reason Not Specified
|
0
|
1
|
Baseline Characteristics
Moderate to Severe Pruritus NRS (MSPN) Analysis Set included participants in the Intent-to-Treat (ITT) Analysis Set who had a baseline NRS value.
Baseline characteristics by cohort
| Measure |
Placebo
n=65 Participants
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
n=128 Participants
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=65 Participants
|
0 Participants
n=128 Participants
|
0 Participants
n=193 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=65 Participants
|
99 Participants
n=128 Participants
|
152 Participants
n=193 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=65 Participants
|
29 Participants
n=128 Participants
|
41 Participants
n=193 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 9.2 • n=65 Participants
|
57 years
STANDARD_DEVIATION 10.0 • n=128 Participants
|
57 years
STANDARD_DEVIATION 9.7 • n=193 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=65 Participants
|
123 Participants
n=128 Participants
|
183 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=65 Participants
|
5 Participants
n=128 Participants
|
10 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=65 Participants
|
29 Participants
n=128 Participants
|
56 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=65 Participants
|
97 Participants
n=128 Participants
|
135 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=65 Participants
|
3 Participants
n=128 Participants
|
6 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=65 Participants
|
7 Participants
n=128 Participants
|
11 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=65 Participants
|
0 Participants
n=128 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
4 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=65 Participants
|
114 Participants
n=128 Participants
|
170 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=65 Participants
|
0 Participants
n=128 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=65 Participants
|
48 Participants
n=128 Participants
|
61 Participants
n=193 Participants
|
|
Region of Enrollment
Argentina
|
13 Participants
n=65 Participants
|
16 Participants
n=128 Participants
|
29 Participants
n=193 Participants
|
|
Region of Enrollment
Mexico
|
6 Participants
n=65 Participants
|
6 Participants
n=128 Participants
|
12 Participants
n=193 Participants
|
|
Region of Enrollment
Spain
|
4 Participants
n=65 Participants
|
7 Participants
n=128 Participants
|
11 Participants
n=193 Participants
|
|
Region of Enrollment
Russia
|
1 Participants
n=65 Participants
|
8 Participants
n=128 Participants
|
9 Participants
n=193 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=65 Participants
|
4 Participants
n=128 Participants
|
8 Participants
n=193 Participants
|
|
Region of Enrollment
Turkey
|
1 Participants
n=65 Participants
|
7 Participants
n=128 Participants
|
8 Participants
n=193 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=65 Participants
|
6 Participants
n=128 Participants
|
8 Participants
n=193 Participants
|
|
Region of Enrollment
Poland
|
5 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
7 Participants
n=193 Participants
|
|
Region of Enrollment
South Korea
|
3 Participants
n=65 Participants
|
4 Participants
n=128 Participants
|
7 Participants
n=193 Participants
|
|
Region of Enrollment
Israel
|
2 Participants
n=65 Participants
|
3 Participants
n=128 Participants
|
5 Participants
n=193 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=65 Participants
|
1 Participants
n=128 Participants
|
3 Participants
n=193 Participants
|
|
Region of Enrollment
Czechia
|
1 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
3 Participants
n=193 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=65 Participants
|
1 Participants
n=128 Participants
|
3 Participants
n=193 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=65 Participants
|
1 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
Chile
|
0 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=65 Participants
|
1 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
Greece
|
2 Participants
n=65 Participants
|
0 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
Hungary
|
0 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
New Zealand
|
2 Participants
n=65 Participants
|
0 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
Romania
|
0 Participants
n=65 Participants
|
2 Participants
n=128 Participants
|
2 Participants
n=193 Participants
|
|
Region of Enrollment
Austria
|
0 Participants
n=65 Participants
|
1 Participants
n=128 Participants
|
1 Participants
n=193 Participants
|
|
Pruritus Numerical Rating Scale (NRS) for Participants With Baseline Pruritus NRS ≥ 4
|
6.6 score on a scale
STANDARD_DEVIATION 1.44 • n=23 Participants • Moderate to Severe Pruritus NRS (MSPN) Analysis Set included participants in the Intent-to-Treat (ITT) Analysis Set who had a baseline NRS value.
|
6.1 score on a scale
STANDARD_DEVIATION 1.42 • n=49 Participants • Moderate to Severe Pruritus NRS (MSPN) Analysis Set included participants in the Intent-to-Treat (ITT) Analysis Set who had a baseline NRS value.
|
6.3 score on a scale
STANDARD_DEVIATION 1.43 • n=72 Participants • Moderate to Severe Pruritus NRS (MSPN) Analysis Set included participants in the Intent-to-Treat (ITT) Analysis Set who had a baseline NRS value.
|
|
Alkaline Phosphatase (ALP) Levels
|
313.8 U/L
STANDARD_DEVIATION 117.68 • n=65 Participants
|
314.6 U/L
STANDARD_DEVIATION 122.96 • n=128 Participants
|
314.3 U/L
STANDARD_DEVIATION 120.90 • n=193 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: The Intend-to-treat Analysis Set was defined as any participant who was randomized into the study and received at least 1 dose of study drug.
Percentages were rounded-off.
Outcome measures
| Measure |
Placebo
n=65 Participants
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
n=128 Participants
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12
|
20.0 percentage of participants
Interval 10.3 to 29.7
|
61.7 percentage of participants
Interval 53.3 to 70.1
|
PRIMARY outcome
Timeframe: First dose date up to last dose plus 30 days (up to 13.4 months)Population: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug.
Percentages were rounded-off.
Outcome measures
| Measure |
Placebo
n=65 Participants
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
n=128 Participants
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
84.6 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
6.2 percentage of participants
|
7.0 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to last dose (up to 13.4 months)Population: Participants in the Safety Analysis Set were analyzed.
Treatment-emergent graded laboratory abnormalities were defined as values that increase at least 2 toxicity grade from baseline at any time post baseline. The laboratory abnormalities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening laboratory abnormality. The data is reported for shift of ≥ 2 grades from baseline in values for hematology and select liver biochemistry. Hematology includes parameters like RBCs, (erythrocytes), hemoglobin, hematocrit, platelets, WBC, WBC differentials (absolute and percentage) including basophils, neutrophils, lymphocytes, eosinophils, and monocytes, etc. Biochemistry included select liver function tests like blood bilirubin, gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Percentages were rounded-off.
Outcome measures
| Measure |
Placebo
n=65 Participants
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
n=128 Participants
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry
Shift ≥ 2 CTCAE grades in haematology
|
12.3 percentage of participants
|
14.1 percentage of participants
|
|
Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry
Shift ≥ 2 CTCAE grades in biochemistry
|
6.2 percentage of participants
|
7.0 percentage of participants
|
SECONDARY outcome
Timeframe: Month 12Population: Participants in Intent-to-treat Analysis Set were analyzed.
Percentages were rounded-off.
Outcome measures
| Measure |
Placebo
n=65 Participants
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
n=128 Participants
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Percentage of Participants With ALP ≤1.0× ULN at Month 12
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
25.0 percentage of participants
Interval 17.5 to 32.5
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: The Moderate to Severe Pruritus NRS Analysis Set included participants in the Intent-to-treat Analysis Set who had a baseline NRS value ≥ 4. Participants with available data were analyzed.
Pruritus NRS is used to rate the intensity of the itching experienced by the participants in the past 24 hours from no itching to worst possible itching by selecting a number from 0 to 10 on Itch Scale. Zero means no itching and 10 means worst imaginable itching.
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
n=45 Participants
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Change From Baseline in Weekly Averaged Pruritus Numerical Rating Scale (NRS) in Participants With NRS ≥ 4 at Month 6
|
-1.7 score on scale
Standard Error 0.41
|
-3.2 score on scale
Standard Error 0.28
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Seladelpar
Serious events: 9 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=65 participants at risk
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
n=128 participants at risk
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Infections and infestations
Covid-19
|
1.5%
1/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.00%
0/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.5%
1/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.00%
0/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.00%
0/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Nervous system disorders
Presyncope
|
1.5%
1/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.00%
0/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Psychiatric disorders
Suicide attempt
|
1.5%
1/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.00%
0/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
Other adverse events
| Measure |
Placebo
n=65 participants at risk
Participants received placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
|
Seladelpar
n=128 participants at risk
Participants received seladelpar 10 mg, orally, once daily, for a duration of up to 12 months.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
6.2%
4/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
2/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
6.2%
8/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
7.0%
9/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Gastrointestinal disorders
Nausea
|
4.6%
3/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
6.2%
8/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
General disorders
Asthenia
|
6.2%
4/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
3.9%
5/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
General disorders
Fatigue
|
6.2%
4/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
6.2%
8/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Infections and infestations
Covid-19
|
13.8%
9/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
18.0%
23/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
5/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
5.5%
7/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Infections and infestations
Pharyngitis
|
7.7%
5/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
3.1%
4/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.2%
6/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
0.78%
1/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
4/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
3.1%
4/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
6.2%
8/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
7.8%
10/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
10/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
4.7%
6/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
|
Vascular disorders
Hypertension
|
6.2%
4/65 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
3.1%
4/128 • All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
All-cause mortality: All-Randomized Analysis Set was defined all participants randomized in the study. Adverse events: The Safety Analysis Set was defined as any participant who received at least 1 dose of study drug. There was only 1 participant who was down-titrated to the 5 mg seladelpar dose during the study. Therefore, the data for adverse events at 5 mg dose were not reported due to participant's confidentiality reasons.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place