Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) (NCT NCT04944784)
NCT ID: NCT04944784
Last Updated: 2024-12-05
Results Overview
Change from baseline to Week 24 in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score using MMRM without multiple imputation; rating scale 0 to 48; higher scores indicate better functional status
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
489 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2024-12-05
Participant Flow
Three participants were randomized but never dosed in the study.
Participant milestones
| Measure |
Reldesemtiv Group, Double-Blind Period
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
Delayed Start Group, Active Drug Period
Participants in this arm were those who received placebo in the double-blind period and reldesemtiv in the active drug period. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Early Start Group, Active Drug Period
Participants in this arm were those who received reldesemtiv in the double-blind and active drug periods. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Reldesemtiv: Reldesemtiv Oral Tablet
|
|---|---|---|---|---|
|
Double-blind Period
STARTED
|
325
|
161
|
0
|
0
|
|
Double-blind Period
COMPLETED
|
180
|
96
|
0
|
0
|
|
Double-blind Period
NOT COMPLETED
|
145
|
65
|
0
|
0
|
|
Active Drug Period
STARTED
|
0
|
0
|
96
|
180
|
|
Active Drug Period
COMPLETED
|
0
|
0
|
31
|
62
|
|
Active Drug Period
NOT COMPLETED
|
0
|
0
|
65
|
118
|
Reasons for withdrawal
| Measure |
Reldesemtiv Group, Double-Blind Period
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
Delayed Start Group, Active Drug Period
Participants in this arm were those who received placebo in the double-blind period and reldesemtiv in the active drug period. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Early Start Group, Active Drug Period
Participants in this arm were those who received reldesemtiv in the double-blind and active drug periods. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Reldesemtiv: Reldesemtiv Oral Tablet
|
|---|---|---|---|---|
|
Double-blind Period
Study Terminated by Sponsor
|
96
|
46
|
0
|
0
|
|
Double-blind Period
Adverse Event
|
20
|
4
|
0
|
0
|
|
Double-blind Period
Withdrawal by Subject
|
15
|
4
|
0
|
0
|
|
Double-blind Period
Death
|
7
|
2
|
0
|
0
|
|
Double-blind Period
Physician Decision
|
2
|
1
|
0
|
0
|
|
Double-blind Period
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Double-blind Period
Sponsor Request
|
2
|
1
|
0
|
0
|
|
Double-blind Period
Planned Medical Assistance in Dying
|
0
|
3
|
0
|
0
|
|
Double-blind Period
Participant Choice
|
1
|
1
|
0
|
0
|
|
Double-blind Period
Progressive Disease
|
2
|
2
|
0
|
0
|
|
Active Drug Period
Study Terminated by Sponsor
|
0
|
0
|
49
|
92
|
|
Active Drug Period
Adverse Event
|
0
|
0
|
3
|
6
|
|
Active Drug Period
Withdrawal by Subject
|
0
|
0
|
4
|
7
|
|
Active Drug Period
Death
|
0
|
0
|
3
|
4
|
|
Active Drug Period
Lack of Efficacy
|
0
|
0
|
2
|
2
|
|
Active Drug Period
Planned Medical Assistance in Dying
|
0
|
0
|
0
|
1
|
|
Active Drug Period
Participant Choice
|
0
|
0
|
0
|
1
|
|
Active Drug Period
Progressive Disease
|
0
|
0
|
4
|
4
|
|
Active Drug Period
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
The Full Analysis Set, which was used for efficacy outcome measures, was used for the baseline measure analysis population.
Baseline characteristics by cohort
| Measure |
Reldesemtiv Group, Double-Blind Period
n=325 Participants
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
n=161 Participants
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
Total
n=486 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 11.00 • n=323 Participants • The Full Analysis Set, which was used for efficacy outcome measures, was used for the baseline measure analysis population.
|
59.8 years
STANDARD_DEVIATION 10.79 • n=159 Participants • The Full Analysis Set, which was used for efficacy outcome measures, was used for the baseline measure analysis population.
|
59.4 years
STANDARD_DEVIATION 10.92 • n=482 Participants • The Full Analysis Set, which was used for efficacy outcome measures, was used for the baseline measure analysis population.
|
|
Sex: Female, Male
Female
|
113 Participants
n=325 Participants
|
64 Participants
n=161 Participants
|
177 Participants
n=486 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=325 Participants
|
97 Participants
n=161 Participants
|
309 Participants
n=486 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=325 Participants
|
12 Participants
n=161 Participants
|
27 Participants
n=486 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
278 Participants
n=325 Participants
|
132 Participants
n=161 Participants
|
410 Participants
n=486 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=325 Participants
|
17 Participants
n=161 Participants
|
49 Participants
n=486 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=325 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=486 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=325 Participants
|
3 Participants
n=161 Participants
|
9 Participants
n=486 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=325 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=486 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=325 Participants
|
4 Participants
n=161 Participants
|
5 Participants
n=486 Participants
|
|
Race (NIH/OMB)
White
|
308 Participants
n=325 Participants
|
149 Participants
n=161 Participants
|
457 Participants
n=486 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=325 Participants
|
5 Participants
n=161 Participants
|
14 Participants
n=486 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=325 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=486 Participants
|
|
Region of Enrollment
United States
|
97 Participants
n=325 Participants
|
56 Participants
n=161 Participants
|
153 Participants
n=486 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=325 Participants
|
3 Participants
n=161 Participants
|
3 Participants
n=486 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=325 Participants
|
0 Participants
n=161 Participants
|
2 Participants
n=486 Participants
|
|
Region of Enrollment
Portugal
|
12 Participants
n=325 Participants
|
3 Participants
n=161 Participants
|
15 Participants
n=486 Participants
|
|
Region of Enrollment
Spain
|
29 Participants
n=325 Participants
|
10 Participants
n=161 Participants
|
39 Participants
n=486 Participants
|
|
Region of Enrollment
Canada
|
48 Participants
n=325 Participants
|
24 Participants
n=161 Participants
|
72 Participants
n=486 Participants
|
|
Region of Enrollment
Netherlands
|
5 Participants
n=325 Participants
|
7 Participants
n=161 Participants
|
12 Participants
n=486 Participants
|
|
Region of Enrollment
Sweden
|
8 Participants
n=325 Participants
|
7 Participants
n=161 Participants
|
15 Participants
n=486 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=325 Participants
|
1 Participants
n=161 Participants
|
7 Participants
n=486 Participants
|
|
Region of Enrollment
Ireland
|
6 Participants
n=325 Participants
|
2 Participants
n=161 Participants
|
8 Participants
n=486 Participants
|
|
Region of Enrollment
Poland
|
9 Participants
n=325 Participants
|
7 Participants
n=161 Participants
|
16 Participants
n=486 Participants
|
|
Region of Enrollment
Denmark
|
1 Participants
n=325 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=486 Participants
|
|
Region of Enrollment
Italy
|
21 Participants
n=325 Participants
|
11 Participants
n=161 Participants
|
32 Participants
n=486 Participants
|
|
Region of Enrollment
Australia
|
22 Participants
n=325 Participants
|
5 Participants
n=161 Participants
|
27 Participants
n=486 Participants
|
|
Region of Enrollment
France
|
24 Participants
n=325 Participants
|
14 Participants
n=161 Participants
|
38 Participants
n=486 Participants
|
|
Region of Enrollment
Germany
|
35 Participants
n=325 Participants
|
11 Participants
n=161 Participants
|
46 Participants
n=486 Participants
|
|
Forced vital capacity (FVC) percent predicted
|
84.5 percent predicted
STANDARD_DEVIATION 14.69 • n=323 Participants • Full Analysis Set was used.
|
85.8 percent predicted
STANDARD_DEVIATION 14.19 • n=159 Participants • Full Analysis Set was used.
|
84.9 percent predicted
STANDARD_DEVIATION 14.53 • n=482 Participants • Full Analysis Set was used.
|
|
ALSFRS-R total score
|
37.2 score on a scale
STANDARD_DEVIATION 4.97 • n=323 Participants • Full Analysis Set was used.
|
36.6 score on a scale
STANDARD_DEVIATION 5.44 • n=159 Participants • Full Analysis Set was used.
|
37.0 score on a scale
STANDARD_DEVIATION 5.14 • n=482 Participants • Full Analysis Set was used.
|
|
Body Mass Index
|
26.9 kg/m^2
STANDARD_DEVIATION 5.67 • n=323 Participants • Full Analysis Set was used.
|
26.4 kg/m^2
STANDARD_DEVIATION 4.41 • n=159 Participants • Full Analysis Set was used.
|
26.8 kg/m^2
STANDARD_DEVIATION 5.29 • n=482 Participants • Full Analysis Set was used.
|
|
ALSAQ-40 Total Score
|
29.1 score on a scale
STANDARD_DEVIATION 15.56 • n=323 Participants • Full Analysis Set was used.
|
31.6 score on a scale
STANDARD_DEVIATION 16.80 • n=159 Participants • Full Analysis Set was used.
|
29.9 score on a scale
STANDARD_DEVIATION 16.00 • n=482 Participants • Full Analysis Set was used.
|
|
Average Maximum Handgrip Strength
|
40.22 pounds
STANDARD_DEVIATION 26.122 • n=323 Participants • Full Analysis Set was used.
|
38.28 pounds
STANDARD_DEVIATION 26.439 • n=159 Participants • Full Analysis Set was used.
|
39.58 pounds
STANDARD_DEVIATION 26.216 • n=482 Participants • Full Analysis Set was used.
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
Change from baseline to Week 24 in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score using MMRM without multiple imputation; rating scale 0 to 48; higher scores indicate better functional status
Outcome measures
| Measure |
Reldesemtiv Group, Double-Blind Period
n=323 Participants
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
n=159 Participants
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
|---|---|---|
|
Effect of Reldesemtiv Versus Placebo on Functional Outcomes in Amyotrophic Lateral Sclerosis (ALS)
|
-5.57 score on a scale
Standard Deviation 5.307
|
-4.76 score on a scale
Standard Deviation 4.420
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
Composite Assessment of Function and Survival (CAFS) compares ranked outcomes based on change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score (0-48; higher scores indicate better function), time in months to dependence on assisted ventilation (DOAV) and time in months to death. Deceased participants are ranked by time-to-death; earliest deaths ranked the lowest. DOAV survivors are ranked more favorably than those who have died but lower than those alive and not DOAV. Non-DOAV survivors are ranked based on change in ALSFRS-R (largest decline in ALSFRS-R ranked lower than less decline or improvement in ALSFRS-R). Unitless ranked scores range from 1-482 (Full Analysis Set) with larger rank scores associated with a better outcome. Ranks were analyzed using stratified Wilcoxon test comparing the ranked scores between reldesemtiv and placebo, adjusting for baseline riluzole and edaravone use. The win probability and the ratio (reldesemtiv vs placebo) are presented.
Outcome measures
| Measure |
Reldesemtiv Group, Double-Blind Period
n=323 Participants
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
n=159 Participants
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
|---|---|---|
|
Effect of Reldesemtiv Versus Placebo on Combined Functional and Survival Outcomes in Amyotrophic Lateral Sclerosis (ALS)
|
232.5 unitless
Interval 211.0 to 257.0
|
264.0 unitless
Interval 209.0 to 291.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
Change from baseline in percent predicted forced vital capacity (FVC) using an in-clinic spirometer; a negative number for change from baseline indicates respiratory function decline relative to baseline
Outcome measures
| Measure |
Reldesemtiv Group, Double-Blind Period
n=323 Participants
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
n=159 Participants
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
|---|---|---|
|
Effect of Reldesemtiv Versus Placebo on Ventilatory Function
|
-10.562 percent predicted
Standard Deviation 12.8178
|
-9.677 percent predicted
Standard Deviation 13.1073
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
Change from baseline in ALSAQ-40 total score. ALSAQ-40 = Amyotrophic Lateral Sclerosis Assessment Questionnaire; summary scores range from 0 (best health status) to 100 (worst health status); ALSAQ-40 total score is calculated as the sum of the summary scores from the 5 domains; lower score corresponds to better health-related quality of life.
Outcome measures
| Measure |
Reldesemtiv Group, Double-Blind Period
n=323 Participants
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
n=159 Participants
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
|---|---|---|
|
Effect of Reldesemtiv Versus Placebo on Quality of Life
|
11.426 score on a scale
Standard Deviation 12.2102
|
9.766 score on a scale
Standard Deviation 11.3662
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
Change from baseline in maximum handgrip strength (average of both hands) measured bilaterally by an electronic hand dynamometer
Outcome measures
| Measure |
Reldesemtiv Group, Double-Blind Period
n=323 Participants
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
n=159 Participants
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
|---|---|---|
|
Effect of Reldesemtiv Versus Placebo on Handgrip Strength
|
-10.134 pounds
Standard Deviation 9.6821
|
-7.370 pounds
Standard Deviation 9.7733
|
Adverse Events
Reldesemtiv Group, Double-Blind Period
Serious events: 41 serious events
Other events: 258 other events
Deaths: 9 deaths
Placebo Group, Double-Blind Period
Serious events: 25 serious events
Other events: 125 other events
Deaths: 6 deaths
Delayed Start Group, Active Drug Period
Serious events: 14 serious events
Other events: 65 other events
Deaths: 5 deaths
Early Start Group, Active Drug Period
Serious events: 33 serious events
Other events: 122 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Reldesemtiv Group, Double-Blind Period
n=325 participants at risk
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
n=161 participants at risk
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
Delayed Start Group, Active Drug Period
n=96 participants at risk
Participants in this arm were those who received placebo in the double-blind period and reldesemtiv in the active drug period. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Early Start Group, Active Drug Period
n=180 participants at risk
Participants in this arm were those who received reldesemtiv in the double-blind and active drug periods. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Reldesemtiv: Reldesemtiv Oral Tablet
|
|---|---|---|---|---|
|
Infections and infestations
pneumonia
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
2.2%
4/180 • Number of events 4 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
2.5%
8/325 • Number of events 8 • up to 48 weeks
|
1.9%
3/161 • Number of events 3 • up to 48 weeks
|
4.2%
4/96 • Number of events 4 • up to 48 weeks
|
3.9%
7/180 • Number of events 7 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.62%
2/325 • Number of events 2 • up to 48 weeks
|
1.9%
3/161 • Number of events 3 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
bronchial secretion retention
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
chronic respiratory failure
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
hypercapnia
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
respiratory arrest
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
respiratory disorder
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.00%
0/325 • up to 48 weeks
|
1.2%
2/161 • Number of events 2 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/325 • up to 48 weeks
|
1.2%
2/161 • Number of events 2 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Gastrointestinal disorders
dysphagia
|
1.8%
6/325 • Number of events 6 • up to 48 weeks
|
3.1%
5/161 • Number of events 5 • up to 48 weeks
|
2.1%
2/96 • Number of events 2 • up to 48 weeks
|
4.4%
8/180 • Number of events 8 • up to 48 weeks
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Gastrointestinal disorders
intestinal pseudo-obstruction
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Gastrointestinal disorders
subileus
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Gastrointestinal disorders
colitis ischaemic
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Gastrointestinal disorders
faecaloma
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
2.1%
2/96 • Number of events 2 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Gastrointestinal disorders
lower gastrointestinal haemorrhage
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Gastrointestinal disorders
oesophagitis
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Infections and infestations
COVID-19
|
0.62%
2/325 • Number of events 2 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Infections and infestations
appendicitis
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Infections and infestations
peritonitis
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Infections and infestations
systemic infection
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Infections and infestations
urinary tract infection
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
1.7%
3/180 • Number of events 3 • up to 48 weeks
|
|
Infections and infestations
vascular device infection
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Infections and infestations
pneumonia aspiration
|
0.00%
0/325 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
1.1%
2/180 • Number of events 2 • up to 48 weeks
|
|
Infections and infestations
sepsis
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
1.1%
2/180 • Number of events 2 • up to 48 weeks
|
|
Infections and infestations
infectious mononucleosis
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Infections and infestations
medical device site infection
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Infections and infestations
respiratory syncytial virus infection
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Infections and infestations
tooth infection
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Infections and infestations
urosepsis
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Investigations
alanine aminotransferase increased
|
0.62%
2/325 • Number of events 2 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Investigations
aspartate aminotransferase increased
|
0.62%
2/325 • Number of events 2 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Investigations
weight decreased
|
0.62%
2/325 • Number of events 2 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Investigations
blood bilirubin increased
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Investigations
hepatic enzyme increased
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Investigations
vital capacity decreased
|
0.00%
0/325 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Investigations
transaminases increased
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
1.1%
2/180 • Number of events 2 • up to 48 weeks
|
|
Investigations
oxygen saturation decreased
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Metabolism and nutrition disorders
hyponatraemia
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Metabolism and nutrition disorders
malnutrition
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Metabolism and nutrition disorders
refeeding syndrome
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Nervous system disorders
amyotropic lateral sclerosis
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
1.1%
2/180 • Number of events 2 • up to 48 weeks
|
|
Nervous system disorders
motor neurone disease
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
1.1%
2/180 • Number of events 2 • up to 48 weeks
|
|
Nervous system disorders
cerebellar stroke
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Nervous system disorders
subarachnoid haemorrhage
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Psychiatric disorders
assisted suicide
|
0.92%
3/325 • Number of events 3 • up to 48 weeks
|
1.9%
3/161 • Number of events 3 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Cardiac disorders
cardiac arrest
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Cardiac disorders
myocardial infarction
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Cardiac disorders
atrial tachycardia
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Hepatobiliary disorders
cholelithiasis
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Hepatobiliary disorders
hepatitis
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Hepatobiliary disorders
hepatotoxicity
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
clavicle fracture
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
concussion
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
fall
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.00%
0/325 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
rib fracture
|
0.00%
0/325 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
jaw fracture
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
General disorders
generalised oedema
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Renal and urinary disorders
prerenal failure
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Renal and urinary disorders
nephrolithiasis
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastases to liver
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic carcinoma
|
0.31%
1/325 • Number of events 1 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/325 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Product Issues
device malfunction
|
0.00%
0/325 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Product Issues
device dislocation
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Surgical and medical procedures
mechanical ventilation
|
0.00%
0/325 • up to 48 weeks
|
0.00%
0/161 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.56%
1/180 • Number of events 1 • up to 48 weeks
|
|
Surgical and medical procedures
euthanasia
|
0.00%
0/325 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
|
Surgical and medical procedures
medical device change
|
0.00%
0/325 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
0.00%
0/96 • up to 48 weeks
|
0.00%
0/180 • up to 48 weeks
|
Other adverse events
| Measure |
Reldesemtiv Group, Double-Blind Period
n=325 participants at risk
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Placebo Group, Double-Blind Period
n=161 participants at risk
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Placebo: Placebo Oral Tablet
|
Delayed Start Group, Active Drug Period
n=96 participants at risk
Participants in this arm were those who received placebo in the double-blind period and reldesemtiv in the active drug period. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Reldesemtiv: Reldesemtiv Oral Tablet
|
Early Start Group, Active Drug Period
n=180 participants at risk
Participants in this arm were those who received reldesemtiv in the double-blind and active drug periods. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Reldesemtiv: Reldesemtiv Oral Tablet
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
9.2%
30/325 • Number of events 30 • up to 48 weeks
|
8.1%
13/161 • Number of events 13 • up to 48 weeks
|
8.3%
8/96 • Number of events 8 • up to 48 weeks
|
6.7%
12/180 • Number of events 12 • up to 48 weeks
|
|
Infections and infestations
urinary tract infection
|
6.2%
20/325 • Number of events 20 • up to 48 weeks
|
5.6%
9/161 • Number of events 9 • up to 48 weeks
|
6.2%
6/96 • Number of events 6 • up to 48 weeks
|
7.2%
13/180 • Number of events 13 • up to 48 weeks
|
|
Infections and infestations
nasopharyngitis
|
5.2%
17/325 • Number of events 17 • up to 48 weeks
|
3.7%
6/161 • Number of events 6 • up to 48 weeks
|
3.1%
3/96 • Number of events 3 • up to 48 weeks
|
1.1%
2/180 • Number of events 2 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
fall
|
17.8%
58/325 • Number of events 58 • up to 48 weeks
|
14.3%
23/161 • Number of events 23 • up to 48 weeks
|
12.5%
12/96 • Number of events 12 • up to 48 weeks
|
15.0%
27/180 • Number of events 27 • up to 48 weeks
|
|
Gastrointestinal disorders
constipation
|
8.0%
26/325 • Number of events 26 • up to 48 weeks
|
7.5%
12/161 • Number of events 12 • up to 48 weeks
|
3.1%
3/96 • Number of events 3 • up to 48 weeks
|
5.6%
10/180 • Number of events 10 • up to 48 weeks
|
|
Gastrointestinal disorders
nausea
|
7.4%
24/325 • Number of events 24 • up to 48 weeks
|
3.7%
6/161 • Number of events 6 • up to 48 weeks
|
2.1%
2/96 • Number of events 2 • up to 48 weeks
|
3.3%
6/180 • Number of events 6 • up to 48 weeks
|
|
Gastrointestinal disorders
diarrhoea
|
6.8%
22/325 • Number of events 22 • up to 48 weeks
|
8.7%
14/161 • Number of events 14 • up to 48 weeks
|
4.2%
4/96 • Number of events 4 • up to 48 weeks
|
7.2%
13/180 • Number of events 13 • up to 48 weeks
|
|
Nervous system disorders
headache
|
7.7%
25/325 • Number of events 25 • up to 48 weeks
|
8.1%
13/161 • Number of events 13 • up to 48 weeks
|
7.3%
7/96 • Number of events 7 • up to 48 weeks
|
3.3%
6/180 • Number of events 6 • up to 48 weeks
|
|
Nervous system disorders
dizziness
|
4.3%
14/325 • Number of events 14 • up to 48 weeks
|
5.0%
8/161 • Number of events 8 • up to 48 weeks
|
1.0%
1/96 • Number of events 1 • up to 48 weeks
|
1.1%
2/180 • Number of events 2 • up to 48 weeks
|
|
Investigations
alanine aminotransferase increased
|
6.5%
21/325 • Number of events 21 • up to 48 weeks
|
1.9%
3/161 • Number of events 3 • up to 48 weeks
|
5.2%
5/96 • Number of events 5 • up to 48 weeks
|
1.7%
3/180 • Number of events 3 • up to 48 weeks
|
|
Investigations
aspartate aminotransferase increased
|
5.5%
18/325 • Number of events 18 • up to 48 weeks
|
0.62%
1/161 • Number of events 1 • up to 48 weeks
|
5.2%
5/96 • Number of events 5 • up to 48 weeks
|
1.1%
2/180 • Number of events 2 • up to 48 weeks
|
|
General disorders
fatigue
|
5.5%
18/325 • Number of events 18 • up to 48 weeks
|
6.2%
10/161 • Number of events 10 • up to 48 weeks
|
2.1%
2/96 • Number of events 2 • up to 48 weeks
|
1.7%
3/180 • Number of events 3 • up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.8%
19/325 • Number of events 19 • up to 48 weeks
|
6.2%
10/161 • Number of events 10 • up to 48 weeks
|
3.1%
3/96 • Number of events 3 • up to 48 weeks
|
5.0%
9/180 • Number of events 9 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
contusion
|
3.7%
12/325 • Number of events 12 • up to 48 weeks
|
3.7%
6/161 • Number of events 6 • up to 48 weeks
|
2.1%
2/96 • Number of events 2 • up to 48 weeks
|
6.1%
11/180 • Number of events 11 • up to 48 weeks
|
|
Gastrointestinal disorders
dysphagia
|
2.2%
7/325 • Number of events 7 • up to 48 weeks
|
3.7%
6/161 • Number of events 6 • up to 48 weeks
|
2.1%
2/96 • Number of events 2 • up to 48 weeks
|
5.0%
9/180 • Number of events 9 • up to 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place