Trial Outcomes & Findings for Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1 (NCT NCT04886518)
NCT ID: NCT04886518
Last Updated: 2025-04-25
Results Overview
The score of the DSS ranges from 0 to 15. A decrease in the DSS score represents an improvement in EDS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline to Week 11
Results posted on
2025-04-25
Participant Flow
Participant milestones
| Measure |
Higher Dose Pitolisant
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Higher Dose Pitolisant
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Overall Study
Noncompliance with study drug
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
The analysis population for this study-specific baseline measure is the modified Intent-to-Treat Population, which includes 8 participants in the higher-dose pitolisant group, 8 in the lower-dose pitolisant group, and 9 in the placebo group.
Baseline characteristics by cohort
| Measure |
Higher Dose Pitolisant
n=10 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=10 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=10 Participants
Matching placebo administered once daily in the morning upon wakening
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
36.5 years
n=10 Participants
|
42.0 years
n=10 Participants
|
41.0 years
n=10 Participants
|
40.0 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
13 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
17 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
29 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
29 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=10 Participants
|
5 participants
n=10 Participants
|
3 participants
n=10 Participants
|
12 participants
n=30 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=10 Participants
|
5 participants
n=10 Participants
|
7 participants
n=10 Participants
|
18 participants
n=30 Participants
|
|
Daytime Sleepiness Scale (DSS)
|
8.5 units on a scale
STANDARD_DEVIATION 3.21 • n=8 Participants • The analysis population for this study-specific baseline measure is the modified Intent-to-Treat Population, which includes 8 participants in the higher-dose pitolisant group, 8 in the lower-dose pitolisant group, and 9 in the placebo group.
|
7.3 units on a scale
STANDARD_DEVIATION 1.16 • n=8 Participants • The analysis population for this study-specific baseline measure is the modified Intent-to-Treat Population, which includes 8 participants in the higher-dose pitolisant group, 8 in the lower-dose pitolisant group, and 9 in the placebo group.
|
7.9 units on a scale
STANDARD_DEVIATION 3.22 • n=9 Participants • The analysis population for this study-specific baseline measure is the modified Intent-to-Treat Population, which includes 8 participants in the higher-dose pitolisant group, 8 in the lower-dose pitolisant group, and 9 in the placebo group.
|
7.8 units on a scale
STANDARD_DEVIATION 2.74 • n=25 Participants • The analysis population for this study-specific baseline measure is the modified Intent-to-Treat Population, which includes 8 participants in the higher-dose pitolisant group, 8 in the lower-dose pitolisant group, and 9 in the placebo group.
|
PRIMARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline DSS assessment.
The score of the DSS ranges from 0 to 15. A decrease in the DSS score represents an improvement in EDS.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=8 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=8 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=9 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Excessive Daytime Sleepiness (EDS) Based on Change in Daytime Sleepiness Scale (DSS) Score
|
-3.8 score on a scale
Standard Deviation 1.98
|
-1.8 score on a scale
Standard Deviation 1.91
|
0.0 score on a scale
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: The analysis population includes all randomized participants who received at least one dose of study drug and have on baseline and at least one post-baseline FSS assessment.
The score of the FSS ranges from 0 to 63. A decrease in the FSS score represents an improvement in fatigue.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=8 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=9 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=10 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Fatigue Based on Change in Fatigue Severity Scale (FSS) Score
|
-0.86 score on a scale
Standard Deviation 1.487
|
-0.36 score on a scale
Standard Deviation 0.367
|
-0.13 score on a scale
Standard Deviation 0.529
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline Cogstate assessment.
The Cogstate Detection Test is a computerized test. A faster speed represents an improvement in psychomotor test performance.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=7 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=7 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=8 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Psychomotor Function Based on Change in Cogstate Detection Test
|
0.02 log10 ms
Standard Deviation 0.058
|
-0.05 log10 ms
Standard Deviation 0.061
|
0.01 log10 ms
Standard Deviation 0.037
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline Cogstate assessment.
The Cogstate Identification Test is a computerized test. A faster speed represents an improvement in attention test performance.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=7 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=7 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=8 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Attention Based on Change in Cogstate Identification Test
|
0.00 log10 ms
Standard Deviation 0.035
|
-0.02 log10 ms
Standard Deviation 0.076
|
-0.02 log10 ms
Standard Deviation 0.052
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline cogstate assessment.
The Cogstate One Back Test is a computerized test. A faster speed represents a better working memory test performance.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=7 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=6 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=8 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Working Memory Based on Change in Cogstate One Back Test
|
0.00 log10 ms
Standard Deviation 0.062
|
-0.01 log10 ms
Standard Deviation 0.032
|
0.00 log10 ms
Standard Deviation 0.050
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline MDHI assessment.
The MDHI score ranges from 0 to 100. A decrease in the MDHI score represents an improvement in overall burden of disease.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=8 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=9 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=10 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Burden of Disease Based on Change in Myotonic Dystrophy Health Index (MDHI)
|
-9.14 score on a scale
Standard Deviation 13.277
|
-2.89 score on a scale
Standard Deviation 8.510
|
0.42 score on a scale
Standard Deviation 5.529
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline ESS assessment.
The score of the ESS ranges from 0 to 24. A decrease in the ESS score represents an improvement in EDS.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=8 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=9 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=10 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Excessive Daytime Sleepiness (EDS) Based on Change in Epworth Sleepiness Scale (ESS) Score
|
-4.9 score on a scale
Standard Deviation 3.98
|
1.3 score on a scale
Standard Deviation 2.83
|
-0.1 score on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline CGI-S assessment.
The CGI-S is a one-item scale that ranges from 0 to 4 with 0 being no EDS and 4 being severe EDS. The scale is completed by the site investigator/clinician. The higher the CGI-S score, the more severe the clinician's perception of the patient's symptoms of EDS.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=8 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=9 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=10 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Excessive Daytime Sleepiness (EDS) Based on Change in Clinical Global Impression of Severity (CGI-S)
|
-0.9 score on a scale
Standard Deviation 0.64
|
-0.2 score on a scale
Standard Deviation 0.44
|
-0.1 score on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline PGI-S assessment.
PGI-S is a one-item scale that ranges from 0 to 4 with 0 being no EDS and 4 being severe EDS. The scale is completed by the patient. The higher the PGI-S score, the more severe the patient's perception of excessive daytime sleepiness.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=8 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=9 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=10 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Excessive Daytime Sleepiness (EDS) Based on Change in Patient Global Impression of Severity (PGI-S)
|
-0.5 score on a scale
Standard Deviation 0.76
|
0.0 score on a scale
Standard Deviation 1.0
|
-0.4 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: This analysis population includes all randomized participants who received at least one dose of study drug and have one baseline and at least one post-baseline Sustained Attention to Response Task assessment.
The Sustained Attention to Response Test provides a measure of vigilance and sustained attention. A number ranging from 1 to 9 is presented on screen. The subject must press a predetermined button (the YES external button) as soon as the number is presented, except when the number is a 3. The number 3 is the default number (no-go stimulus) for which a response should be inhibited, and the subject should not press the predetermined button. The no-go stimulus can be configured to be a number other than 3. Performance is measured by calculating the number of errors made during the test over the course of 225 trials. Performance is measured by calculating the error score, which is the sum of trials where a response was provided when a 3 was presented and trials where no response was provided when a number other than 3 was presented. A decrease in the SART score represents an improvement in sustained attention.
Outcome measures
| Measure |
Higher Dose Pitolisant
n=6 Participants
Pitolisant 35.6 mg administered once daily in the morning upon wakening
|
Lower Dose Pitolisant
n=7 Participants
Pitolisant 17.8 mg administered once daily in the morning upon wakening
|
Placebo
n=8 Participants
Matching placebo administered once daily in the morning upon wakening
|
|---|---|---|---|
|
Change in Sustained Attention Based on Sustained Attention to Response Task (SART)
|
-2.33 scores on a scale
Standard Deviation 5.428
|
1.43 scores on a scale
Standard Deviation 4.467
|
21.88 scores on a scale
Standard Deviation 68.689
|
Adverse Events
Higher Dose Pitolisant
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Lower Dose Pitolisant
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Higher Dose Pitolisant
n=10 participants at risk
Pitolisant 35.6 mg administered once daily in the morning
|
Lower Dose Pitolisant
n=10 participants at risk
Pitolisant 17.8 mg administered once daily in the morning
|
Placebo
n=10 participants at risk
Matching placebo administered once daily in the morning
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
30.0%
3/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
40.0%
4/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
30.0%
3/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
20.0%
2/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
20.0%
2/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
20.0%
2/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Nervous system disorders
Migraine
|
20.0%
2/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Eye disorders
Blepharospasm
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Infections and infestations
Hordeolum
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
General disorders
Thirst decreased
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Investigations
Weight increased
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Investigations
Heart rate irregular
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
0.00%
0/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
10.0%
1/10 • Data presented for adverse events occurring from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 11 weeks.
The Double-Blind safety population included all patients who were enrolled and took at least one dose of double-blind study drug.
|
Additional Information
Sharon Wolfe-Schwartz, Executive Director, Medical and Regulatory Writing
Harmony Biosciences
Phone: 267-965-0270
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place