Trial Outcomes & Findings for A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults (NCT NCT01987427)
NCT ID: NCT01987427
Last Updated: 2019-09-30
Results Overview
The nine common serotonergic AEs were headache, dizziness, nausea, fatigue, dry mouth, diarrhea, vomiting, insomnia, and/or anxiety.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
344 participants
Primary outcome timeframe
Baseline up to Week 12 (end of treatment)
Results posted on
2019-09-30
Participant Flow
Participants took part in the study at 12 sites in the United States from 30 October 2013 to 03 September 2014.
A total of 344 participants were screened and enrolled, of which 106 were screen failures and 238 were randomized to receive study treatment, out of which 235 participants were treated.
Participant milestones
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
Participants received lorcaserin 10 milligram (mg) tablet along with phentermine placebo-matching capsule, orally, twice daily (BID) for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, once daily (QD), and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
78
|
78
|
79
|
|
Overall Study
COMPLETED
|
64
|
68
|
59
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
20
|
Reasons for withdrawal
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
Participants received lorcaserin 10 milligram (mg) tablet along with phentermine placebo-matching capsule, orally, twice daily (BID) for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, once daily (QD), and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
Baseline Characteristics
A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults
Baseline characteristics by cohort
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 11.08 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 11.32 • n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 12 (end of treatment)Population: The full analysis set included all randomized participants who received at least one dose of the study drug.
The nine common serotonergic AEs were headache, dizziness, nausea, fatigue, dry mouth, diarrhea, vomiting, insomnia, and/or anxiety.
Outcome measures
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least One of Nine Adverse Events (AEs) of Main Interests That May Related to Serotonergic Reaction
|
37.2 percentage of participants
|
42.3 percentage of participants
|
40.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The safety analysis set included all randomized participants who received at least one dose of study drug and had at least one post-baseline safety assessment.
Outcome measures
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and AEs Leading to Study Drug Discontinuation
TEAE
|
50 Participants
|
52 Participants
|
54 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and AEs Leading to Study Drug Discontinuation
SAE
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and AEs Leading to Study Drug Discontinuation
AEs leading to study drug discontinuation
|
4 Participants
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The safety analysis set included all randomized participants who received at least one dose of study drug and had at least one post-baseline safety assessment. Participants who were evaluable for this measure for given laboratory parameter were included in the assessment.
Outcome measures
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Gamma glutamyl transferase: high
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Phosphorus: low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Potassium: high
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Total bilirubin: high
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Triglycerides: High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Uric acid: high
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Hemoglobin: low
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Lymphocytes: high
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
Neutrophils: low
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values
White blood cell (WBC) count: low
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8 and 12Population: The Modified Intent-to-Treat (MITT) set included all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement. Participants who were evaluable for this measure at given time period were included in the assessment.
Outcome measures
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Baseline
|
105.33 kilogram (kg)
Standard Deviation 20.994
|
105.04 kilogram (kg)
Standard Deviation 23.399
|
106.63 kilogram (kg)
Standard Deviation 19.703
|
|
Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Change at Week 1
|
-0.94 kilogram (kg)
Standard Deviation 1.290
|
-1.36 kilogram (kg)
Standard Deviation 1.341
|
-1.97 kilogram (kg)
Standard Deviation 1.477
|
|
Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Change at Week 2
|
-1.56 kilogram (kg)
Standard Deviation 1.547
|
-2.43 kilogram (kg)
Standard Deviation 1.566
|
-2.94 kilogram (kg)
Standard Deviation 1.925
|
|
Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Change at Week 4
|
-2.27 kilogram (kg)
Standard Deviation 1.823
|
-3.81 kilogram (kg)
Standard Deviation 2.442
|
-4.44 kilogram (kg)
Standard Deviation 2.606
|
|
Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Change at Week 8
|
-2.87 kilogram (kg)
Standard Deviation 2.691
|
-5.76 kilogram (kg)
Standard Deviation 3.711
|
-6.33 kilogram (kg)
Standard Deviation 3.913
|
|
Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Change at Week 12
|
-3.48 kilogram (kg)
Standard Deviation 3.727
|
-7.00 kilogram (kg)
Standard Deviation 5.950
|
-7.55 kilogram (kg)
Standard Deviation 4.725
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8 and 12Population: The MITT set included all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement. Participants who were evaluable for this measure at given time period were included in the assessment.
Outcome measures
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Week 12
|
-3.29 percent change
Standard Deviation 3.363
|
-6.69 percent change
Standard Deviation 5.377
|
-7.23 percent change
Standard Deviation 4.611
|
|
Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Week 8
|
-2.77 percent change
Standard Deviation 2.551
|
-5.54 percent change
Standard Deviation 3.466
|
-6.03 percent change
Standard Deviation 3.722
|
|
Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Week 1
|
-0.93 percent change
Standard Deviation 1.212
|
-1.28 percent change
Standard Deviation 1.234
|
-1.82 percent change
Standard Deviation 1.358
|
|
Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Week 2
|
-1.47 percent change
Standard Deviation 1.451
|
-2.33 percent change
Standard Deviation 1.465
|
-2.75 percent change
Standard Deviation 1.787
|
|
Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12
Week 4
|
-2.18 percent change
Standard Deviation 1.744
|
-3.68 percent change
Standard Deviation 2.265
|
-4.20 percent change
Standard Deviation 2.459
|
SECONDARY outcome
Timeframe: Week 12 (end of treatment)Population: The MITT set included all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement.
Outcome measures
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 5 Percent (%) Weight Reduction at Week 12
|
28.2 percentage of participants
|
59.0 percentage of participants
|
70.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (end of treatment)Population: The MITT population consisted of all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement. Participants who were evaluable for this measure at given time period were included in the assessment.
Outcome measures
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Waist Circumference and Hip Circumference at Week 12
Waist Circumference: Baseline
|
112.2 centimeter (cm)
Standard Deviation 13.82
|
112.2 centimeter (cm)
Standard Deviation 15.09
|
114.0 centimeter (cm)
Standard Deviation 12.02
|
|
Change From Baseline in Waist Circumference and Hip Circumference at Week 12
Waist Circumference: Change at Week 12
|
-3.4 centimeter (cm)
Standard Deviation 7.98
|
-4.7 centimeter (cm)
Standard Deviation 10.31
|
-7.1 centimeter (cm)
Standard Deviation 5.53
|
|
Change From Baseline in Waist Circumference and Hip Circumference at Week 12
Hip Circumference: Baseline
|
124.1 centimeter (cm)
Standard Deviation 14.30
|
123.7 centimeter (cm)
Standard Deviation 14.27
|
125.4 centimeter (cm)
Standard Deviation 12.81
|
|
Change From Baseline in Waist Circumference and Hip Circumference at Week 12
Hip Circumference: Change at Week 12
|
-2.8 centimeter (cm)
Standard Deviation 8.05
|
-3.6 centimeter (cm)
Standard Deviation 11.29
|
-6.2 centimeter (cm)
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (end of treatment)Population: The MITT set included all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement. Participants who were evaluable for this measure at given time period were included in the assessment.
Outcome measures
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 Participants
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 Participants
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 Participants
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Waist to Hip Circumference Ratio at Week 12
Baseline
|
0.91 ratio
Standard Deviation 0.083
|
0.91 ratio
Standard Deviation 0.091
|
0.91 ratio
Standard Deviation 0.084
|
|
Change From Baseline in Waist to Hip Circumference Ratio at Week 12
Change at Week 12
|
-0.01 ratio
Standard Deviation 0.102
|
-0.01 ratio
Standard Deviation 0.044
|
-0.01 ratio
Standard Deviation 0.036
|
Adverse Events
Lorcaserin 10 mg BID + Phentermine Placebo BID
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
Lorcaserin 10 mg BID + Phentermine 15 mg BID
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 participants at risk
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 participants at risk
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 participants at risk
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
Other adverse events
| Measure |
Lorcaserin 10 mg BID + Phentermine Placebo BID
n=78 participants at risk
Participants received lorcaserin 10 mg tablet along with phentermine placebo-matching capsule, orally, BID for 12 weeks.
|
Lorcaserin 10mg BID+Phentermine 15mg QD+Phentermine Placebo QD
n=78 participants at risk
Participants received lorcaserin 10 mg tablet, orally, BID along with phentermine 15 mg capsule, orally, QD, and phentermine placebo-matching capsule, orally, QD for 12 weeks.
|
Lorcaserin 10 mg BID + Phentermine 15 mg BID
n=79 participants at risk
Participants received lorcaserin 10 mg tablet along with phentermine 15 mg capsule, orally, BID for 12 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Eye disorders
Iritis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Constipation
|
5.1%
4/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
9.0%
7/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
13.9%
11/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
5/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Dry mouth
|
6.4%
5/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
26.9%
21/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
22.8%
18/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Flatulence
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
6.4%
5/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
7.6%
6/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Salivary gland pain
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
3.8%
3/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
3.8%
3/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Chest discomfort
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Chills
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Energy increased
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Eye complication associated with device
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Fatigue
|
10.3%
8/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
3.8%
3/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
6.3%
5/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Feeling cold
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Feeling jittery
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Gait disturbance
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Local swelling
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Oedema peripheral
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Pain
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Pyrexia
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
General disorders
Thirst
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Immune system disorders
Perfume sensitivity
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Cystitis
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Folliculitis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Gastroenteritis
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Infection
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Parotitis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Sinusitis
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
3.8%
3/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Viral infection
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Blood potassium increased
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Blood pressure increased
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Electrocardiogram T wave abnormal
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
Heart rate increased
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Investigations
White blood cells urine positive
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
3.8%
3/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Burning sensation
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Disturbance in attention
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
5.1%
4/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
10.1%
8/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Headache
|
17.9%
14/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
9.0%
7/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
13.9%
11/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Migraine
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Syncope
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Tension headache
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Nervous system disorders
Tremor
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Abnormal dreams
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Depression
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Initial insomnia
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Insomnia
|
9.0%
7/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
5.1%
4/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Renal and urinary disorders
Urine flow decreased
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
5/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
2.5%
2/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
2/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Surgical and medical procedures
Tooth extraction
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Vascular disorders
Flushing
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Vascular disorders
Hot flush
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
|
Vascular disorders
Hypertension
|
0.00%
0/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
1.3%
1/78 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
0.00%
0/79 • First dose of study drug (Baseline) up to Week 16 (30 days after last dose of study drug on Week 12/end of treatment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place