Trial Outcomes & Findings for Phase 2 Clinical Trial of SGS-742 Therapy in Succinic Semialdehyde Dehydrogenase Deficiency (NCT NCT02019667)
NCT ID: NCT02019667
Last Updated: 2020-02-24
Results Overview
The ABAS questionnaire was completed by the participant's parent or caregiver at the end of each six month treatment period.The ABAS provides a comprehensive picture of adaptive skills across the lifespan. The questionnaire addresses Conceptual, Social and Practical skills including communication, self-direction, use of leisure time, health, safety and self-care. The General Adaptive Composite score ranges from \<40 to \>160 with a lower score representing lower adaptive behavior. The difference between Placebo and Baseline and Study Drug and Baseline were obtained. These values were averaged across individuals to report a mean and a standard deviation of the baseline-to-treatment period change. The means for each treatment can be compared to have a baseline-adjusted treatment effect interpretation. A positive change represents an improvement in adaptive skills compared with baseline and a negative change represents a decline in adaptive skills compared with baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
baseline and six months
Results posted on
2020-02-24
Participant Flow
Participants were recruited and enrolled in the protocol between March 2014 and October 2017, with assistance from referring physicians in the community and the SSADH foundation. A total of 19 participants were enrolled; 16 completed dosing in both placebo and active drug arms.
Following a baseline visit, participants were randomized to receive either placebo or study drug for 6 months (Phase 1) followed by 6 months of the alternate treatment (Phase 2). Participants completed a 9-week washout period following each phase of the study.
Participant milestones
| Measure |
Placebo First, Then SGS-742
Participants were administered Placebo, followed by a washout period, and then administered SGS-742
|
SGS-742 First, Then Placebo
Participants were administered SGS-742, followed by a washout period, and then administered Placebo
|
|---|---|---|
|
First Intervention (6 Months)
STARTED
|
10
|
9
|
|
First Intervention (6 Months)
COMPLETED
|
10
|
8
|
|
First Intervention (6 Months)
NOT COMPLETED
|
0
|
1
|
|
Washout Period (9 Weeks)
STARTED
|
10
|
6
|
|
Washout Period (9 Weeks)
COMPLETED
|
10
|
6
|
|
Washout Period (9 Weeks)
NOT COMPLETED
|
0
|
0
|
|
2nd Intervention (6 Months)
STARTED
|
10
|
8
|
|
2nd Intervention (6 Months)
COMPLETED
|
10
|
6
|
|
2nd Intervention (6 Months)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo First, Then SGS-742
Participants were administered Placebo, followed by a washout period, and then administered SGS-742
|
SGS-742 First, Then Placebo
Participants were administered SGS-742, followed by a washout period, and then administered Placebo
|
|---|---|---|
|
First Intervention (6 Months)
Adverse Event
|
0
|
1
|
|
2nd Intervention (6 Months)
Adverse Event
|
0
|
1
|
|
2nd Intervention (6 Months)
Physician Decision
|
0
|
1
|
Baseline Characteristics
Phase 2 Clinical Trial of SGS-742 Therapy in Succinic Semialdehyde Dehydrogenase Deficiency
Baseline characteristics by cohort
| Measure |
All Study Participants
n=19 Participants
Participants with SSADH Deficiency who were randomized to receive either SGS-742 or Placebo
|
|---|---|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 7.31 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline and six monthsPopulation: The ABAS was not able to be completed for all participants.
The ABAS questionnaire was completed by the participant's parent or caregiver at the end of each six month treatment period.The ABAS provides a comprehensive picture of adaptive skills across the lifespan. The questionnaire addresses Conceptual, Social and Practical skills including communication, self-direction, use of leisure time, health, safety and self-care. The General Adaptive Composite score ranges from \<40 to \>160 with a lower score representing lower adaptive behavior. The difference between Placebo and Baseline and Study Drug and Baseline were obtained. These values were averaged across individuals to report a mean and a standard deviation of the baseline-to-treatment period change. The means for each treatment can be compared to have a baseline-adjusted treatment effect interpretation. A positive change represents an improvement in adaptive skills compared with baseline and a negative change represents a decline in adaptive skills compared with baseline.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants with SSADH Deficiency when on placebo for six months
Placebo
|
Study Drug
n=13 Participants
Participants with SSADH Deficiency receiving SGS-742 when on study drug for six months
SGS-742
|
|---|---|---|
|
Change From Baseline on the Adaptive Behavior Assessment System (ABAS) Test at the End of the Study Drug and Placebo Treatment Periods
|
5.2 scores on a scale
Standard Deviation 7.1
|
4.5 scores on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline and Six monthsPopulation: We were unable to obtain Motor Thresholds for all participants at all three timepoints, resulting in different N for each time period. All available data is reported.
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at a sufficient intensity to trigger action potentials in nearby neurons. The motor threshold is defined as the minimum percentage of the stimulator output that evoked a motor evoked potential of more than 50µV in at least 5 out of 10 trials. Motor threshold was measured at the end of the study drug period and the end of the Placebo period. The differences between Placebo and Baseline, and SGS and Baseline were obtained. A decrease from baseline value indicates increased cortical excitability and an increase from baseline value indicates reduced cortical excitability. These values were averaged across individuals to report a mean and standard deviation of this baseline-to-treatment period change. The mean for each treatment can be compared to have a baseline-adjusted treatment effect.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants with SSADH Deficiency when on placebo for six months
Placebo
|
Study Drug
n=17 Participants
Participants with SSADH Deficiency receiving SGS-742 when on study drug for six months
SGS-742
|
|---|---|---|
|
Change From Baseline of TMS Measurement of Motor Threshold at the End of the Study Drug and Placebo Treatment Periods
|
-2 percentage of stimulator output
Standard Deviation 7.1
|
-0.5 percentage of stimulator output
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline and Six monthsPopulation: We were unable to obtain Motor Thresholds for all participants at all three timepoints, resulting in different N for each time period. All available data is reported.
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at a sufficient intensity to trigger action potentials in nearby neurons. Intracortical facilitation (ICF) and inhibition (ICI) were studied using a paired stimulus paradigm. The motor threshold (MT) was first established. The conditioning stimulus (70% MT) followed by the test stimulus (120% MT) was delivered at an interstimulus interval (ISI) of 10 ms for ICF. Each run consisted of 10 trials, and the amplitude ratio of the mean conditioned Motor Evoked Potential (MEP) to control MEP was determined. A larger amplitude ratio indicates greater cortical excitability. The differences between Placebo and Baseline, and SGS and Baseline were obtained. These values were averaged across individuals to report a mean.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants with SSADH Deficiency when on placebo for six months
Placebo
|
Study Drug
n=17 Participants
Participants with SSADH Deficiency receiving SGS-742 when on study drug for six months
SGS-742
|
|---|---|---|
|
Change From Baseline of TMS Measurement of Intracortical Facilitation at the End of the Study Drug and Placebo Treatment Periods
|
49.9 ratio of MEP amplitude
Standard Deviation 61.9
|
40.5 ratio of MEP amplitude
Standard Deviation 50.2
|
SECONDARY outcome
Timeframe: Baseline and Six monthsPopulation: We were unable to obtain Motor Thresholds for all participants at all three timepoints, resulting in different N for each time period. All available data is reported.
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at a sufficient intensity to trigger action potentials in nearby neurons. Intracortical facilitation and inhibition were studied using a paired stimulus paradigm. The motor threshold (MT) was first established. The conditioning stimulus (70% MT) followed by the test stimulus (120% MT) was delivered at an interstimulus interval (ISI) of 2 ms for short ICI. Each run consisted of 10 trials, and the amplitude ratio of the mean conditioned Motor Evoked Potential (MEP) to control MEP was determined. A larger amplitude ratio indicates greater cortical excitability. The differences between Placebo and Baseline, and SGS and Baseline were obtained. These values were averaged across individuals to report a mean.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants with SSADH Deficiency when on placebo for six months
Placebo
|
Study Drug
n=17 Participants
Participants with SSADH Deficiency receiving SGS-742 when on study drug for six months
SGS-742
|
|---|---|---|
|
Change From Baseline of TMS Measurement of Short Interval Intracortical Inhibition (Short ICI) at the End of the Study Drug and Placebo Treatment Periods
|
35.5 ratio of MEP amplitude
Standard Deviation 123.4
|
-11.0 ratio of MEP amplitude
Standard Deviation 54.8
|
SECONDARY outcome
Timeframe: Baseline and Six monthsPopulation: We were unable to obtain Motor Thresholds for all participants at all three timepoints, resulting in different N for each time period. All available data is reported.
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at a sufficient intensity to trigger action potentials in nearby neurons.Intracortical facilitation and inhibition were studied using a paired stimulus paradigm. The motor threshold (MT) was first established. The conditioning stimulus (70% MT) followed by the test stimulus (120% MT) was delivered at 100 ms for long ICI. Each run consisted of 10 trials, and the amplitude ratio of the mean conditioned Motor Evoked Potential (MEP) to control MEP was determined. A larger amplitude ratio indicates greater cortical excitability. The differences between Placebo and Baseline, and SGS and Baseline were obtained. These values were averaged across individuals to report a mean.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants with SSADH Deficiency when on placebo for six months
Placebo
|
Study Drug
n=17 Participants
Participants with SSADH Deficiency receiving SGS-742 when on study drug for six months
SGS-742
|
|---|---|---|
|
Change From Baseline of TMS Measurement of Long Interval Intracortical Inhibition (Long ICI) at the End of the Study Drug and Placebo Treatment Periods
|
-9.3 ratio of MEP amplitude
Standard Deviation 112.0
|
0.3 ratio of MEP amplitude
Standard Deviation 98.6
|
SECONDARY outcome
Timeframe: Six monthsPopulation: One subject withdrew prior to end of Phase 1
A physical examination was administered by a physician to subjects at the end of each six month treatment period, i.e., following completion of a six month period on SGS-742 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0=No observation; 1=Stable baseline findings; 2=New asymptomatic finding; 3=Patient reports some worsening of a baseline daily function associated with new finding; 4=Patient unable to carry out a baseline daily function associated with new finding
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants with SSADH Deficiency when on placebo for six months
Placebo
|
Study Drug
n=18 Participants
Participants with SSADH Deficiency receiving SGS-742 when on study drug for six months
SGS-742
|
|---|---|---|
|
Results of Physical Examination at the End of the Study Drug and Placebo Treatment Periods
2
|
4 Participants
|
3 Participants
|
|
Results of Physical Examination at the End of the Study Drug and Placebo Treatment Periods
0
|
0 Participants
|
0 Participants
|
|
Results of Physical Examination at the End of the Study Drug and Placebo Treatment Periods
1
|
14 Participants
|
15 Participants
|
|
Results of Physical Examination at the End of the Study Drug and Placebo Treatment Periods
3
|
0 Participants
|
0 Participants
|
|
Results of Physical Examination at the End of the Study Drug and Placebo Treatment Periods
4
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Washout Period Following Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Study Drug
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Washout Period Following Study Drug
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Participants with SSADH Deficiency while on placebo for six months
Placebo
|
Washout Period Following Placebo
n=16 participants at risk
Participants with SSADH Deficiency having received Placebo, during the 9 week washout period
|
Study Drug
n=19 participants at risk
Participants with SSADH Deficiency receiving SGS-742 while on study drug for six months
SGS-742
|
Washout Period Following Study Drug
n=18 participants at risk
Participants with SSADH Deficiency having received SGS-742, during the 9 week washout period
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
2/18 • Number of events 3 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
21.1%
4/19 • Number of events 6 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Renal and urinary disorders
Abnormal Urinary Analysis results
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Psychiatric disorders
Agitation
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Ear and labyrinth disorders
Allergic Rhinitis
|
5.6%
1/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
12.5%
2/16 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Gastrointestinal disorders
Blister in the oral cavity
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Gastrointestinal disorders
Bloating
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
1/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Concentration Impairment
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
2/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
General disorders
Fatigue
|
27.8%
5/18 • Number of events 5 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
General disorders
Fever
|
11.1%
2/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
15.8%
3/19 • Number of events 4 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Vascular disorders
Flushing
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Infections and infestations
Head lice
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Hyperactivity
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Gastrointestinal disorders
Increased appetite
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Insomnia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Psychiatric disorders
Irritability
|
11.1%
2/18 • Number of events 5 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
11.1%
2/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Psychiatric disorders
Labile
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Infections and infestations
Labile
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Lethargy
|
16.7%
3/18 • Number of events 3 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Ear and labyrinth disorders
Nasal congestion
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Gastrointestinal disorders
Nausea
|
27.8%
5/18 • Number of events 5 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
10.5%
2/19 • Number of events 3 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Renal and urinary disorders
Priapism
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Infections and infestations
Rash
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
2/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
21.1%
4/19 • Number of events 4 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Eye disorders
Red eyes
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Seizures
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Sleepiness
|
11.1%
2/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Infections and infestations
Strep throat
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
11.1%
2/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
1/18 • Number of events 2 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
10.5%
2/19 • Number of events 3 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
4/18 • Number of events 4 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
10.5%
2/19 • Number of events 3 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
|
Investigations
Weight gain
|
5.6%
1/18 • Number of events 1 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/16 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/19 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
0.00%
0/18 • Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place