Trial Outcomes & Findings for Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine (NCT NCT03303092)
NCT ID: NCT03303092
Last Updated: 2021-07-29
Results Overview
Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
357 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2021-07-29
Participant Flow
Participant milestones
| Measure |
TEV-48125 (225/225/225 mg) Group
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
|---|---|---|---|
|
Overall Study
STARTED
|
121
|
119
|
117
|
|
Overall Study
COMPLETED
|
118
|
113
|
112
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
5
|
Reasons for withdrawal
| Measure |
TEV-48125 (225/225/225 mg) Group
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
Baseline Characteristics
Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine
Baseline characteristics by cohort
| Measure |
TEV-48125 (225/225/225 mg) Group
n=121 Participants
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
n=119 Participants
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
n=117 Participants
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
348 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
44.2 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
302 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
121 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
357 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
102 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
301 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days.
Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.
Outcome measures
| Measure |
TEV-48125 (225/225/225 mg) Group
n=121 Participants
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
n=117 Participants
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
n=116 Participants
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
|---|---|---|---|
|
Mean Change From Baseline in the Monthly (28 Days) Average Number of Migraine Days During the 12-week Period After the First Dose of Investigational Medicinal Product (IMP)
|
-4.00 days/month
Standard Error 0.37
|
-4.02 days/month
Standard Error 0.38
|
-1.02 days/month
Standard Error 0.38
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects meeting responder criteria.
Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.
Outcome measures
| Measure |
TEV-48125 (225/225/225 mg) Group
n=50 Participants
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
n=53 Participants
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
n=13 Participants
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
|---|---|---|---|
|
Proportion of Subjects Reaching at Least 50% Reduction in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP
|
41.3 percentage of participants
|
45.3 percentage of participants
|
11.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit.
Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).
Outcome measures
| Measure |
TEV-48125 (225/225/225 mg) Group
n=121 Participants
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
n=117 Participants
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
n=116 Participants
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
|---|---|---|---|
|
Mean Change From Baseline in the Monthly Average Number of Days With Use of Any Acute Headache Medications During the 12-week Period After the First Dose of IMP
|
-3.30 days/month
Standard Error 0.34
|
-3.29 days/month
Standard Error 0.36
|
-0.46 days/month
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit.
Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.
Outcome measures
| Measure |
TEV-48125 (225/225/225 mg) Group
n=97 Participants
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
n=94 Participants
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
n=94 Participants
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
|---|---|---|---|
|
Mean Change From Baseline in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP in Patients Not Receiving Concomitant Preventive Migraine Medications
|
-4.42 days/month
Standard Error 0.36
|
-4.21 days/month
Standard Error 0.37
|
-1.40 days/month
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit.
Using the MIDAS questionnaire, subjects assessed the degree of headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the last 3 months. The MIDAS questionnaire was a 5-item instrument. The total of the scores of the first 5 questions was used for grading the level of disability, with scores of 0 to 5, 6 to 10, 11 to 20, and ≥ 21 interpreted as disability grades I (little or no disability), II (mild disability), III (moderate disability), and IV (severe disability), respectively.
Outcome measures
| Measure |
TEV-48125 (225/225/225 mg) Group
n=118 Participants
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
n=112 Participants
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
n=112 Participants
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
|---|---|---|---|
|
Mean Change From Baseline in Disability Score, as Measured by Migraine Disability Assessment (MIDAS) Questionnaire at 4 Weeks After the Final (Third) Dose of IMP
|
-12.64 score on a scale
Standard Error 1.42
|
-12.55 score on a scale
Standard Error 1.49
|
-7.41 score on a scale
Standard Error 1.46
|
Adverse Events
TEV-48125 (225/225/225 mg) Group
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
TEV-48125 (675 mg/Placebo/Placebo) Group
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TEV-48125 (225/225/225 mg) Group
n=121 participants at risk
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
|
TEV-48125 (675 mg/Placebo/Placebo) Group
n=118 participants at risk
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
|
Placebo Group
n=117 participants at risk
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
|
|---|---|---|---|
|
General disorders
Injection site macule
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Malaise
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Pyrexia
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Chest discomfort
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Chest pain
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Feeling abnormal
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Blood and lymphatic system disorders
Purpura non-thrombocytopenic
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Cardiac disorders
Tachycardia
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Ear and labyrinth disorders
Vertigo
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Eye disorders
Chalazion
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Eye disorders
Dry eye
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Eye disorders
Glaucoma
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Eye disorders
Keratitis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
2.5%
3/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Dental caries
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Gastritis
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Nausea
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
2.6%
3/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Stomatitis
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Toothache
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
2.5%
3/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site erythema
|
15.7%
19/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
11.9%
14/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
12.8%
15/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site induration
|
14.9%
18/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
11.9%
14/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
10.3%
12/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site pain
|
9.1%
11/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
13.6%
16/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
6.0%
7/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site pruritus
|
5.8%
7/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site swelling
|
3.3%
4/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site rash
|
1.7%
2/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Fatigue
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site dermatitis
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site haemorrhage
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
3.4%
4/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Feeling cold
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site bruising
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site eczema
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site haematoma
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site urticaria
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Injection site warmth
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
General disorders
Oedema peripheral
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.7%
2/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Immune system disorders
Seasonal allergy
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
17/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
12.7%
15/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
13.7%
16/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Influenza
|
5.0%
6/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Helicobacter infection
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Pharyngitis
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Streptococcal infection
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Cystitis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.7%
2/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Alanine aminotransferase increased
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Aspartate aminotransferase increased
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Blood urine present
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Glucose urine present
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Blood pressure increased
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Occult blood positive
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Investigations
Weight decreased
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
2.5%
3/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Headache
|
1.7%
2/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
3.4%
4/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Hyperaesthesia
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Sciatica
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Vascular headache
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
2.6%
3/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Migraine
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
2.6%
3/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Radial nerve palsy
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Psychiatric disorders
Stress
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
1.7%
2/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.7%
2/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.5%
3/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.83%
1/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
|
Surgical and medical procedures
Tumour excision
|
0.00%
0/121 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.00%
0/118 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
0.85%
1/117 • Double-blind treatment period (12 weeks)
Safety set (SS):Subjects who received the IMP at least once.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place