Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH (NCT NCT02784444)
NCT ID: NCT02784444
Last Updated: 2020-09-16
Results Overview
* A decrease of at least 2 points in NAS at 12 months. * At least a 1 point reduction in either ballooning or inflammation from baseline to 12 months. * no increase in CRN fibrosis score (i.e., an increase of 1 stage or more) from baseline to 12 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
392 participants
Primary outcome timeframe
12 months (360 days)
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Placebo
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
94
|
99
|
98
|
101
|
|
Overall Study
COMPLETED
|
78
|
90
|
86
|
88
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
12
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
Baseline characteristics by cohort
| Measure |
Placebo
n=94 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=99 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=98 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=101 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
Total
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
56.1 years
STANDARD_DEVIATION 10.64 • n=21 Participants
|
|
Age, Customized
Age at Enrollment · < 55 years
|
43 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Age, Customized
Age at Enrollment · >= 55 years
|
51 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
235 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
228 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
273 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian Or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black Or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian Or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
85 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
360 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 months (360 days)Population: Subjects in the Modified Intent-to-Treat Set with available baseline biopsy and 12-month biopsy taken within 14 days of study drug discontinuation.
* A decrease of at least 2 points in NAS at 12 months. * At least a 1 point reduction in either ballooning or inflammation from baseline to 12 months. * no increase in CRN fibrosis score (i.e., an increase of 1 stage or more) from baseline to 12 months.
Outcome measures
| Measure |
Placebo
n=74 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=84 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=82 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=86 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Number of Participants With Hepatic Histological Improvement in NAS
|
22 Participants
|
25 Participants
|
27 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 12 months (360 days)Population: Analysis Population Description: Subjects in the Modified Intent-to-Treat Set with available baseline biopsy and 12-month biopsy taken within 14 days of study drug discontinuation.
* CRN ballooning score of 0 at 12-months * CRN inflammation score of 0 or 1 at 12-months * No increase in CRN fibrosis score from baseline to 12-months
Outcome measures
| Measure |
Placebo
n=74 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=84 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=82 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=86 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Number of Subjects With Resolution of NASH With no Worsening of Fibrosis at 12 Months.
|
15 Participants
|
17 Participants
|
23 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 12 months (360 days)Population: Analysis Population Description: Subjects in the Modified Intent-to-Treat Set with available baseline biopsy and 12-month biopsy taken within 14 days of study drug discontinuation.
* Decrease in fibrosis CRN staging score of \>= 1 full stage from baseline to 12 months * No increase in ballooning CRN score from baseline to 12 months * No increase in inflammation CRN score from baseline to 12-months
Outcome measures
| Measure |
Placebo
n=74 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=84 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=82 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=86 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Number of Subjects With Improvement of Fibrosis (CRN Staging Score) by at Least 1 Stage With no Worsening of NASH at 12 Months.
|
16 Participants
|
20 Participants
|
23 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 12 months (360 days)Population: Subjects in the Modified Intent-to-Treat Set with available baseline biopsy and 12-month biopsy taken within 14 days of study drug discontinuation.
NAS is the sum of the scores of steatosis, inflammation, and ballooning. It has a range of 0 to 8 with higher scores indicating worse disease severity.
Outcome measures
| Measure |
Placebo
n=74 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=84 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=83 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=86 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Mean Change From Baseline in NAFLD Activity Score (NAS)
|
-0.6 Scores on a scale
Standard Deviation 1.80
|
-1.0 Scores on a scale
Standard Deviation 1.66
|
-1.1 Scores on a scale
Standard Deviation 1.74
|
-1.2 Scores on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: 12 months (360 days)Population: Analysis Population Description: Subjects in the Modified Intent-to-Treat Set with available baseline biopsy and 12-month biopsy taken within 14 days of study drug discontinuation.
Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis.
Outcome measures
| Measure |
Placebo
n=74 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=84 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=83 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=86 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Mean Change From Baseline in CRN Steatosis Score
|
-0.4 Scores on a scale
Standard Deviation 0.80
|
-0.6 Scores on a scale
Standard Deviation 0.88
|
-0.5 Scores on a scale
Standard Deviation 0.93
|
-0.7 Scores on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: 12 months (360 days)Population: Subjects in the Modified Intent-to-Treat Set with available baseline biopsy and 12-month biopsy taken within 14 days of study drug discontinuation
Inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe inflammation.
Outcome measures
| Measure |
Placebo
n=74 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=84 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=83 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=86 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Mean Change From Baseline in CRN Inflammation Score
|
-0.1 Scores on a scale
Standard Deviation 0.70
|
-0.1 Scores on a scale
Standard Deviation 0.71
|
-0.2 Scores on a scale
Standard Deviation 0.56
|
-0.1 Scores on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 12 months (360 days)Population: Analysis Population Description: Subjects in the Modified Intent-to-Treat Set with available baseline biopsy and 12-month biopsy taken within 14 days of study drug discontinuation.
Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning.
Outcome measures
| Measure |
Placebo
n=74 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=84 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=83 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=86 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Mean Change From Baseline in CRN Ballooning Score
|
-0.2 Scores on a scale
Standard Deviation 0.98
|
-0.4 Scores on a scale
Standard Deviation 0.94
|
-0.4 Scores on a scale
Standard Deviation 0.94
|
-0.4 Scores on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: 12 months (360 days)Population: Analysis Population Description: Subjects in the Modified Intent-to-Treat Set with available baseline biopsy and 12-month biopsy taken within 14 days of study drug discontinuation.
Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.
Outcome measures
| Measure |
Placebo
n=74 Participants
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=84 Participants
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=82 Participants
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=86 Participants
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Mean Change From Baseline in CRN Fibrosis Staging Score
|
0.0 Scores on a scale
Standard Deviation 1.10
|
0.1 Scores on a scale
Standard Deviation 1.07
|
-0.1 Scores on a scale
Standard Deviation 1.16
|
-0.1 Scores on a scale
Standard Deviation 1.27
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 75 other events
Deaths: 1 deaths
MSDC-0602K 62.5 mg
Serious events: 5 serious events
Other events: 78 other events
Deaths: 0 deaths
MSDC-0602K 125 mg
Serious events: 13 serious events
Other events: 76 other events
Deaths: 1 deaths
MSDC-0602K 250 mg
Serious events: 7 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=94 participants at risk
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=99 participants at risk
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=98 participants at risk
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=101 participants at risk
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Infections and infestations
Diverticultis
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
2.0%
2/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Urinary tract infections
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Device related infection
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
2.0%
2/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
General disorders
Non-cardiac chest pain
|
2.1%
2/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Nervous system disorders
Brain stem ischaemia
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Nervous system disorders
Seizure
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Nervous system disorders
Syncope
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Vascular disorders
Hypertensive emergency
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Vascular disorders
Malignant hypertension
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Surgical and medical procedures
Transurethral prostatetectomy
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.00%
0/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
Other adverse events
| Measure |
Placebo
n=94 participants at risk
Matching Placebo capsule taken once daily for 360 days
Placebo: Placebo capsules
|
MSDC-0602K 62.5 mg
n=99 participants at risk
MSDC-0602K 62.5 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 125 mg
n=98 participants at risk
MSDC-0602K 125 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
MSDC-0602K 250 mg
n=101 participants at risk
MSDC-0602K 250 mg taken once daily for 360 days
MSDC-0602K: MSDC-0602K capsules
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
4.3%
4/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
10.1%
10/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
3.1%
3/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.0%
5/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Sinusitis
|
5.3%
5/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
6.1%
6/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
7/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
6.1%
6/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
3.1%
3/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.0%
5/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Infections and infestations
Bronchitis
|
3.2%
3/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
2.0%
2/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
6.1%
6/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.0%
5/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
7/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
8.1%
8/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
7.1%
7/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
12.9%
13/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Gastrointestinal disorders
Dirrhoea
|
5.3%
5/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
7.1%
7/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
9.2%
9/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
5/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
7.1%
7/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
6.9%
7/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
4/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
2.0%
2/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
5/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
2.0%
2/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
3.0%
3/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
5/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
3.0%
3/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
5/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
3.1%
3/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
6.9%
7/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
3/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
3.0%
3/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
8.5%
8/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
2.0%
2/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
3.0%
3/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
General disorders
Oedema peripheral
|
6.4%
6/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
9.2%
9/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.0%
5/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Nervous system disorders
Headache
|
2.1%
2/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
3/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
4.0%
4/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/94 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
5.1%
5/99 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
1.0%
1/98 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
0.99%
1/101 • From first dose of study treatment up to the final study visit, at an average of 1 year and 2 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60