Trial Outcomes & Findings for Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD) (NCT NCT03386487)
NCT ID: NCT03386487
Last Updated: 2024-02-14
Results Overview
Change in the average number of times per day of self-reported cannabis consumption measured by the Timeline Follow Back approach for Cannabis Use in which participants quantify and report their frequency of cannabis use prior to study participation and throughout the study. Differences between groups in the change from baseline use (2 weeks prior to randomization) in the average number of times per day of self-reported consumption of cannabis or a cannabis containing product in the last 4 weeks of treatment captured using the daily TLFB data collected during CAROMA calls.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
228 participants
Primary outcome timeframe
Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.
Results posted on
2024-02-14
Participant Flow
Participant milestones
| Measure |
PF-04457845
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
PF 04457845: Study medication will be administered at 4mg by mouth daily for eight weeks.
|
Placebo
Subjects will be randomized to placebo
Placebo Oral Tablet: Placebo comparator will be administered by mouth daily for eight weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
112
|
|
Overall Study
COMPLETED
|
89
|
91
|
|
Overall Study
NOT COMPLETED
|
27
|
21
|
Reasons for withdrawal
| Measure |
PF-04457845
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
PF 04457845: Study medication will be administered at 4mg by mouth daily for eight weeks.
|
Placebo
Subjects will be randomized to placebo
Placebo Oral Tablet: Placebo comparator will be administered by mouth daily for eight weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
11
|
7
|
|
Overall Study
Physician Decision
|
11
|
8
|
Baseline Characteristics
Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)
Baseline characteristics by cohort
| Measure |
PF-04457845
n=116 Participants
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
PF 04457845: Study medication will be administered at 4mg by mouth daily for eight weeks.
|
Placebo
n=112 Participants
Subjects will be randomized to placebo
Placebo Oral Tablet: Placebo comparator will be administered by mouth daily for eight weeks.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
116 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
31.48 years
STANDARD_DEVIATION 10.32 • n=99 Participants
|
32.91 years
STANDARD_DEVIATION 10.52 • n=107 Participants
|
32.18 years
STANDARD_DEVIATION 10.42 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
68 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
47 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Marital Status
Married
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Marital Status
In a Relationship & Living Together
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Marital Status
In a Relationship
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Marital Status
Divorced or Annulled
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Marital Status
Separated
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Marital Status
Single
|
45 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Marital Status
Never Married
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Education
Less than High School Diploma
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Education
High School Diploma
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Education
GED
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Education
Some College
|
29 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Education
Associates Degree
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Education
Bachelors Degree
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Education
Masters Degree
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Education
Professional / Doctoral Degree
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Employment Status
Full-Time Job
|
54 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Employment Status
Part-Time Job
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Employment Status
Temporarily Laid Off, On Leave
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Employment Status
Looking for Work, Unemployed
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Employment Status
Retired
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Employment Status
Disabled, Permanently/Temp
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Employment Status
Keeping House
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Employment Status
Student
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Employment Status
Other
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Cannabis Use Severity (CUD)
Moderate
|
63 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Cannabis Use Severity (CUD)
Severe
|
53 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.Change in the average number of times per day of self-reported cannabis consumption measured by the Timeline Follow Back approach for Cannabis Use in which participants quantify and report their frequency of cannabis use prior to study participation and throughout the study. Differences between groups in the change from baseline use (2 weeks prior to randomization) in the average number of times per day of self-reported consumption of cannabis or a cannabis containing product in the last 4 weeks of treatment captured using the daily TLFB data collected during CAROMA calls.
Outcome measures
| Measure |
PF-04457845
n=105 Participants
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
PF 04457845: Study medication will be administered at 4mg by mouth daily for eight weeks.
|
Placebo
n=109 Participants
Subjects will be randomized to placebo
Placebo Oral Tablet: Placebo comparator will be administered by mouth daily for eight weeks.
|
|---|---|---|
|
Time Line Follow Back (TLFB) for Cannabis Use
Week 1
|
1.921 times/day of self-reported cannabis use
Standard Deviation 1.538
|
1.768 times/day of self-reported cannabis use
Standard Deviation 1.758
|
|
Time Line Follow Back (TLFB) for Cannabis Use
Week 2
|
1.201 times/day of self-reported cannabis use
Standard Deviation 1.638
|
1.066 times/day of self-reported cannabis use
Standard Deviation 1.702
|
|
Time Line Follow Back (TLFB) for Cannabis Use
Week 3
|
1.308 times/day of self-reported cannabis use
Standard Deviation 1.881
|
1.06 times/day of self-reported cannabis use
Standard Deviation 1.663
|
|
Time Line Follow Back (TLFB) for Cannabis Use
Week 4
|
1.316 times/day of self-reported cannabis use
Standard Deviation 1.956
|
0.998 times/day of self-reported cannabis use
Standard Deviation 1.414
|
|
Time Line Follow Back (TLFB) for Cannabis Use
Week 5
|
1.234 times/day of self-reported cannabis use
Standard Deviation 1.8
|
1.214 times/day of self-reported cannabis use
Standard Deviation 2.22
|
|
Time Line Follow Back (TLFB) for Cannabis Use
Week 6
|
1.252 times/day of self-reported cannabis use
Standard Deviation 1.639
|
1.079 times/day of self-reported cannabis use
Standard Deviation 1.645
|
|
Time Line Follow Back (TLFB) for Cannabis Use
Week 7
|
1.321 times/day of self-reported cannabis use
Standard Deviation 1.762
|
0.91 times/day of self-reported cannabis use
Standard Deviation 1.3
|
|
Time Line Follow Back (TLFB) for Cannabis Use
Week 8
|
1.113 times/day of self-reported cannabis use
Standard Deviation 1.481
|
0.936 times/day of self-reported cannabis use
Standard Deviation 1.417
|
PRIMARY outcome
Timeframe: baseline, week 1, week 3, week 5, week 7, and week 9 visitsAssay of the levels of the principal metabolite of THC (THC-COOH) in urine samples at baseline and bi-weekly over 8 weeks.
Outcome measures
| Measure |
PF-04457845
n=106 Participants
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
PF 04457845: Study medication will be administered at 4mg by mouth daily for eight weeks.
|
Placebo
n=106 Participants
Subjects will be randomized to placebo
Placebo Oral Tablet: Placebo comparator will be administered by mouth daily for eight weeks.
|
|---|---|---|
|
Urinary Levels of THC-COOH (ng/ml)
Screening
|
5.959 ng/ml
Standard Deviation 6.633
|
5.571 ng/ml
Standard Deviation 6.542
|
|
Urinary Levels of THC-COOH (ng/ml)
Week 1
|
5.077 ng/ml
Standard Deviation 4.837
|
5.747 ng/ml
Standard Deviation 7.456
|
|
Urinary Levels of THC-COOH (ng/ml)
Week 3
|
3.069 ng/ml
Standard Deviation 3.385
|
3.92 ng/ml
Standard Deviation 6.673
|
|
Urinary Levels of THC-COOH (ng/ml)
Week 5
|
3.482 ng/ml
Standard Deviation 5.064
|
4.465 ng/ml
Standard Deviation 7.411
|
|
Urinary Levels of THC-COOH (ng/ml)
Week 7
|
3.241 ng/ml
Standard Deviation 5.67
|
4.223 ng/ml
Standard Deviation 7.724
|
|
Urinary Levels of THC-COOH (ng/ml)
Week 9
|
3.222 ng/ml
Standard Deviation 3.913
|
3.952 ng/ml
Standard Deviation 7.511
|
Adverse Events
PF-04457845
Serious events: 2 serious events
Other events: 89 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04457845
n=116 participants at risk
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
PF 04457845: Study medication will be administered at 4mg by mouth daily for eight weeks.
|
Placebo
n=112 participants at risk
Subjects will be randomized to placebo
Placebo Oral Tablet: Placebo comparator will be administered by mouth daily for eight weeks.
|
|---|---|---|
|
General disorders
Abscess Removal
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
Other adverse events
| Measure |
PF-04457845
n=116 participants at risk
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
PF 04457845: Study medication will be administered at 4mg by mouth daily for eight weeks.
|
Placebo
n=112 participants at risk
Subjects will be randomized to placebo
Placebo Oral Tablet: Placebo comparator will be administered by mouth daily for eight weeks.
|
|---|---|---|
|
Metabolism and nutrition disorders
Increased Appetite
|
5.2%
6/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
4.5%
5/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
2.7%
3/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Metabolism and nutrition disorders
Food Craving
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.3%
5/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
4.5%
5/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Hand Fracture
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Ligament Sprain
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Injury, poisoning and procedural complications
Toenail Laceration
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Injury, poisoning and procedural complications
Retinal Detachment
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Injury, poisoning and procedural complications
Lump on Right Side of Chest
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Blood bilirubin Increased
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Elevated Absolute Eosinophils
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Heart Rate Increased
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Hepatic Enzyme Increased
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Transaminitis
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Weight Decreased
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Investigations
Weight Increased
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.1%
14/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
10.7%
12/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Improved Sleep
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Initial Insomnia
|
6.9%
8/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Insomnia
|
14.7%
17/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
17.0%
19/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Migraine
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Poor Quality Sleep
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
8.0%
9/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Restlessness
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Sedation
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Abnormal Dreams
|
14.7%
17/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
17.0%
19/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Ageusia
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Disorientation
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Sleep Paralysis
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Dizziness
|
12.9%
15/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
4.5%
5/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Headache
|
20.7%
24/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
23.2%
26/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Dissociative State
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Somnolence
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
9.8%
11/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Nervous system disorders
Tremor
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
2.7%
3/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Agitation
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Anxiety
|
13.8%
16/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
12.5%
14/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Apathy
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Clearheaded
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Flushing
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Hyperhidrosis
|
5.2%
6/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
2.7%
3/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Hot Flush
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
2.7%
3/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Lethargy
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Night Sweats
|
2.6%
3/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
2.7%
3/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Peripheral Swelling
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Puncture site bruise
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Pyrexia
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
3.6%
4/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Thirst
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Immune system disorders
Hypoergia
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Immune system disorders
Rhinitis allergic
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Infections and infestations
Respiratory Tract Infection
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
2.7%
3/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Infections and infestations
Sinusitis
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Infections and infestations
Abscess
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Infections and infestations
Influenza
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Infections and infestations
Herpes Simplex
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Infections and infestations
Urinary Tract Infection
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Cardiac disorders
Tachycardia
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Ear and labyrinth disorders
Ear Pain
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Ear and labyrinth disorders
Vertigo
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Eye disorders
Hordeolum
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Eye disorders
Vision Blurred
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.9%
8/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
6.2%
7/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Bruxism
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Constipation
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
5/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
7.1%
8/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
3.6%
4/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
5.4%
6/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Flatulence
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Nausea
|
12.9%
15/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
14.3%
16/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Toothache
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
8/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
7.1%
8/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Asthenia
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Blue Tongue
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Chills
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Chest Discomfort
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Chest Pain
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Energy Increased
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Fatigue
|
5.2%
6/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
6.2%
7/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
General disorders
Feeling Abnormal
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Disturbed Thinking in Context of Cannabis Intoxication
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Depressed Mood
|
13.8%
16/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
5.4%
6/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Depressive Symptoms
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Euphoric Mood
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Flashes
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Internal feeling of being high without using THC
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Irritability
|
16.4%
19/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
15.2%
17/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Mood Swings
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Panic Attack
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Paranoia
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Slight Increase in Alcohol Use
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Stress
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Psychiatric disorders
Suicidal Ideation
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Renal and urinary disorders
Cystitis
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Renal and urinary disorders
Nocturia
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Renal and urinary disorders
Pollakiuria
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
1.8%
2/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Reproductive system and breast disorders
Intermenstrual Bleeding
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Reproductive system and breast disorders
Libido Decreased
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Reproductive system and breast disorders
Nocturnal Emission
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Reproductive system and breast disorders
Vulvovaginal Swelling
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
4/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
2.7%
3/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 Positive
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.8%
9/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
8.9%
10/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.7%
2/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.89%
1/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Skin and subcutaneous tissue disorders
Paraesthesia
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
3/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
3.6%
4/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Vascular disorders
Hypotension
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
|
Vascular disorders
Orthostatic Hypotension
|
0.86%
1/116 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
0.00%
0/112 • The adverse events reported were collected throughout the treatment phase of the study (randomization to the end of week 8; i.e. the beginning of the treatment phase of the study through the end of the treatment phase of the study).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place