Trial Outcomes & Findings for Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain (NCT NCT04707157)
NCT ID: NCT04707157
Last Updated: 2023-11-02
Results Overview
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
TERMINATED
PHASE2
68 participants
Baseline, Week 8
2023-11-02
Participant Flow
Participant milestones
| Measure |
600 Milligram (mg) LY3556050
Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.
|
Placebo
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
23
|
|
Overall Study
Received at Least One Dose of Study Drug
|
45
|
23
|
|
Overall Study
COMPLETED
|
20
|
14
|
|
Overall Study
NOT COMPLETED
|
25
|
9
|
Reasons for withdrawal
| Measure |
600 Milligram (mg) LY3556050
Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.
|
Placebo
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Sponsor's decision
|
1
|
0
|
|
Overall Study
Physician Decision
|
8
|
5
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain
Baseline characteristics by cohort
| Measure |
600 mg LY3556050
n=45 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=23 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.20 years
STANDARD_DEVIATION 9.01 • n=93 Participants
|
58.30 years
STANDARD_DEVIATION 10.67 • n=4 Participants
|
59.50 years
STANDARD_DEVIATION 9.57 • n=27 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
|
6.44 score on a scale
STANDARD_DEVIATION 1.70 • n=93 Participants
|
6.45 score on a scale
STANDARD_DEVIATION 1.50 • n=4 Participants
|
6.44 score on a scale
STANDARD_DEVIATION 1.62 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
600 mg LY3556050
n=20 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=14 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
|
-2.75 score on a scale
Interval -3.5 to -2.01
|
-1.19 score on a scale
Interval -2.14 to -0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale), its impact on daily functioning (Pain Interference scale), and other aspects of pain (for example, location of pain, relief from medications). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life assessed on 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=no interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
600 mg LY3556050
n=23 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=14 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
|
-2.31 score on a scale
Interval -3.0 to -1.62
|
-1.27 score on a scale
Interval -2.2 to -0.38
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Patients Global Impression of Change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
600 mg LY3556050
n=23 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=14 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
|
2.28 score on a scale
Interval 1.88 to 2.69
|
3.19 score on a scale
Interval 2.68 to 3.71
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
600 mg LY3556050
n=20 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=14 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline for Worst Pain Intensity as Measured by NRS
|
-3.06 score on a scale
Interval -3.81 to -2.31
|
-1.06 score on a scale
Interval -2.04 to -0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
600 mg LY3556050
n=22 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=14 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline on the Visual Analog Scale (VAS) for Pain
|
-30.20 score on a scale
Interval -37.54 to -22.78
|
-11.08 score on a scale
Interval -20.88 to -1.24
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
600 mg LY3556050
n=23 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=14 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep
|
0.30 Hours per night
Interval -0.17 to 0.77
|
0.41 Hours per night
Interval -0.22 to 1.03
|
SECONDARY outcome
Timeframe: Week 8Population: All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
Total amount of rescue medication use as measured by average daily dosage. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
600 mg LY3556050
n=20 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=14 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
|
214.28 mg per day (mg/day)
Interval -1.06 to 433.1
|
484.20 mg per day (mg/day)
Interval 201.57 to 761.45
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.
The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
600 mg LY3556050
n=23 Participants
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=14 Participants
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
|
0.09 score on a scale
Interval -0.09 to 0.26
|
0.05 score on a scale
Interval -0.16 to 0.27
|
Adverse Events
600 mg LY3556050
Placebo
Serious adverse events
| Measure |
600 mg LY3556050
n=45 participants at risk
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=23 participants at risk
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.2%
1/45 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
600 mg LY3556050
n=45 participants at risk
Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.
|
Placebo
n=23 participants at risk
Participants received placebo BID every 12 hours for up to 8 weeks.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
4.4%
2/45 • Number of events 2 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.4%
2/45 • Number of events 2 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Number of events 3 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.4%
2/45 • Number of events 2 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
15.6%
7/45 • Number of events 7 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
13.0%
3/23 • Number of events 3 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
6/45 • Number of events 7 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
21.7%
5/23 • Number of events 6 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
2/45 • Number of events 3 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
15.6%
7/45 • Number of events 7 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
4/45 • Number of events 5 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
11.1%
5/45 • Number of events 5 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
3/45 • Number of events 3 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Investigations
Anion gap increased
|
15.6%
7/45 • Number of events 7 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
8.9%
4/45 • Number of events 4 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Investigations
Blood gastrin increased
|
4.4%
2/45 • Number of events 2 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Investigations
Blood insulin increased
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Investigations
Cystatin c increased
|
4.4%
2/45 • Number of events 2 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
6.7%
3/45 • Number of events 3 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.4%
2/45 • Number of events 2 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
13.0%
3/23 • Number of events 3 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.9%
4/45 • Number of events 4 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
8.7%
2/23 • Number of events 3 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • Number of events 3 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
4.4%
2/45 • Number of events 2 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
0.00%
0/23 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/45 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline through Week 8
All enrolled participants who took at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place