Trial Outcomes & Findings for D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions (NCT NCT01981759)
NCT ID: NCT01981759
Last Updated: 2020-03-25
Results Overview
The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2020-03-25
Participant Flow
As the screening period lasts up to four weeks before the baseline visit and participants are not randomized until week 3, 59 participants were either screen failures or dropped out before randomization to treatment group.
Participant milestones
| Measure |
Placebo
Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
D-Cycloserine
Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
Baseline (Week 1)
|
28
|
30
|
|
Overall Study
Randomization (Week 3)
|
28
|
30
|
|
Overall Study
Completed Week 12
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data is reported for all participants who reported "race". Not all participants provided responses for this item.
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
D-Cycloserine
n=30 Participants
Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.55 Years
STANDARD_DEVIATION 11.97 • n=28 Participants
|
44.60 Years
STANDARD_DEVIATION 13.26 • n=30 Participants
|
44.82 Years
STANDARD_DEVIATION 12.57 • n=58 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=28 Participants
|
11 Participants
n=30 Participants
|
23 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=28 Participants
|
19 Participants
n=30 Participants
|
35 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=28 Participants
|
2 Participants
n=30 Participants
|
5 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=28 Participants
|
28 Participants
n=30 Participants
|
53 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
0 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
0 Participants
n=50 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
1 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
1 Participants
n=50 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
0 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
0 Participants
n=50 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
9 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
21 Participants
n=50 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
|
Race (NIH/OMB)
White
|
10 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
14 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
24 Participants
n=50 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
1 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
4 Participants
n=50 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
0 Participants
n=25 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
0 Participants
n=50 Participants • Data is reported for all participants who reported "race". Not all participants provided responses for this item.
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: For week 12 values, only those who completed the week 12 assessments are included in the analysis.
The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.
Outcome measures
| Measure |
Placebo
n=28 Participants
Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
D-Cycloserine
n=30 Participants
Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
|---|---|---|
|
Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D)
Baseline PSYRATS Delusion Subscale Total
|
14.26 units on a scale
Standard Deviation 5.30
|
11.83 units on a scale
Standard Deviation 5.58
|
|
Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D)
Week 12 PSYRATS Delusion Subscale Total
|
12.18 units on a scale
Standard Deviation 3.79
|
11.91 units on a scale
Standard Deviation 5.26
|
SECONDARY outcome
Timeframe: 7 days after Baseline, and 7 days after Screening visit 2Population: Reported summary statistics are for participants randomized at three weeks. One randomized participant is excluded from these results as they did not complete the Logical Memory Test at the baseline visit.
The Logical Memory Test of the Wechsler Memory Scale is a measure of verbal declarative memory. We are using it to evaluate memory consolidation by analyzing the number of thematic elements recalled after a delay of 7 days. Participants are read two different stories-one at Screening visit #2 and one at Baseline. They are asked to recall specific items and narrative themes after 7 days. Scores range from 0-7, 7 indicating perfect thematic recall, and 0 indicating no thematic elements were remembered and worse thematic recall. We hypothesize that improved memory consolidation (assessed with the Logical Memory Test) tested 7 days after the first dose of D-cycloserine will predict improvement of delusional scores measured by the PSYRATS-D. The reported outcome (change in Logical Memory Test score) was calculated by subtracting the screening visit 2 score from the baseline score for each participant.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
D-Cycloserine
n=30 Participants
Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
|---|---|---|
|
Change in Logical Memory Test-WMS-III
|
-0.96 Change in a score
Standard Deviation 1.32
|
-1.03 Change in a score
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Week 3 to Week 4Population: Two participants were randomized and took medication (placebo or DCS) at week 3, but were lost to follow up between week 3 and week 4. One participant was randomized at week 3 but did not take medication or complete the ABE exercise at week 3. These three participants are not included in the reported data.
The Alternate Belief Exercise is a measurement of cognitive flexibility. The scores range from 0-21, and a higher score indicates an increased number of alternative beliefs reported. This outcome measurement reports the change in number of alternate beliefs generated from weeks 3 to 4 as a predictor of improvement of the PSYRATS Delusions Subscale total score at 12 weeks. Thus a higher score in this outcome measurement indicates a greater number of alternative beliefs reported at week 4 as compared to week 3. This implies greater cognitive flexibility at week 4 as compared to week 3 directly after drug administration.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
D-Cycloserine
n=29 Participants
Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
|---|---|---|
|
Change in Alternate Beliefs Exercise (ABE)
|
1.15 Change in a score
Standard Deviation 2.80
|
0.59 Change in a score
Standard Deviation 1.84
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 24 deaths
D-Cycloserine
Serious events: 3 serious events
Other events: 24 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
D-Cycloserine
n=30 participants at risk
Participants will receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Hospitalization
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Infections and infestations
Medical Hospitalization
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
6.7%
2/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
D-Cycloserine
n=30 participants at risk
Participants will receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).
Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
|
|---|---|---|
|
Metabolism and nutrition disorders
Appetite Decreased
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Metabolism and nutrition disorders
Appetite Increased
|
7.1%
2/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
16.7%
5/30 • Number of events 5 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Metabolism and nutrition disorders
Abdominal Discomfort
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Reproductive system and breast disorders
Anorgasmia
|
7.1%
2/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Apathy
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Auditory Hallucinations
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Back Ache
|
7.1%
2/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.7%
3/28 • Number of events 4 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
6.7%
2/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Skin and subcutaneous tissue disorders
Blisters
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Endocrine disorders
Blood Sugar Increased
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Eye disorders
Blurred Vision
|
10.7%
3/28 • Number of events 3 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Cardiac disorders
Bradycardia
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Skin and subcutaneous tissue disorders
Bruise
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Skin and subcutaneous tissue disorders
Burning Skin
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Vascular disorders
Chest Pain
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Infections and infestations
Common Cold
|
14.3%
4/28 • Number of events 5 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Concentration Impaired
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
6.7%
2/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Infections and infestations
Nasal Congestion
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
13.3%
4/30 • Number of events 4 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
6.7%
2/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Impaired Coordination
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
10.0%
3/30 • Number of events 3 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Decreased Sleep
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Difficulty Thinking
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Dizziness Upon Standing
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Drooling
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Drowsiness
|
7.1%
2/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Drowsy on Awakening
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
General disorders
Dry Mouth
|
7.1%
2/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
10.0%
3/30 • Number of events 3 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Ear and labyrinth disorders
Ear Feels Clogged
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Eye disorders
Eye Hemorrhage
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
General disorders
Facial Swelling
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Vascular disorders
Faintness
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Falling Down
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
False Sensation
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
6.7%
2/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Fatigue
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
13.3%
4/30 • Number of events 5 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Feeling Strange
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Infections and infestations
Flu-like Symptoms
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Hepatobiliary disorders
Frequency of Urination
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
6.7%
2/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Infections and infestations
Gingival Bleeding
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
General disorders
Hair Loss
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
General disorders
Hair Thinning
|
3.6%
1/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Hallucinations
|
7.1%
2/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 3 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
16.7%
5/30 • Number of events 6 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
General disorders
Hot Flashes
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Cardiac disorders
Hypertension
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Social circumstances
Incarceration
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Infections and infestations
Infection
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Insomnia
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Irritability
|
10.7%
3/28 • Number of events 3 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
16.7%
5/30 • Number of events 5 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Jaw Pain
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
3.6%
1/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Reproductive system and breast disorders
Libido Decreased
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disease Obstruvtive
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Memory Impaired
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
6.7%
2/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Mental Concentration Difficulty
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Mental Dullness
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm/Twitch
|
7.1%
2/28 • Number of events 3 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness/Fatigue
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
7.1%
2/28 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
6.7%
2/30 • Number of events 2 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
10.0%
3/30 • Number of events 3 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Nightmares
|
7.1%
2/28 • Number of events 3 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
13.3%
4/30 • Number of events 4 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Nervous system disorders
Numbness
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/28 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
3.3%
1/30 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Psychiatric disorders
Paranoia
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
|
Infections and infestations
Pneumonia and Dehydration
|
3.6%
1/28 • Number of events 1 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
0.00%
0/30 • Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place