Trial Outcomes & Findings for A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China (NCT NCT01931475)
NCT ID: NCT01931475
Last Updated: 2016-05-23
Results Overview
BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
Baseline, Week 13
Results posted on
2016-05-23
Participant Flow
Participant milestones
| Measure |
60 mg Duloxetine
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment.1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Period 1: Double-Blind Treatment Phase
STARTED
|
205
|
202
|
|
Period 1: Double-Blind Treatment Phase
Received at Least 1 Dose of Study Drug
|
199
|
198
|
|
Period 1: Double-Blind Treatment Phase
COMPLETED
|
166
|
176
|
|
Period 1: Double-Blind Treatment Phase
NOT COMPLETED
|
39
|
26
|
|
Period 2: Extension Treatment Phase
STARTED
|
166
|
176
|
|
Period 2: Extension Treatment Phase
Received at Least 1 Dose of Study Drug
|
166
|
175
|
|
Period 2: Extension Treatment Phase
COMPLETED
|
162
|
157
|
|
Period 2: Extension Treatment Phase
NOT COMPLETED
|
4
|
19
|
Reasons for withdrawal
| Measure |
60 mg Duloxetine
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment.1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Period 1: Double-Blind Treatment Phase
Adverse Event
|
20
|
10
|
|
Period 1: Double-Blind Treatment Phase
Lost to Follow-up
|
1
|
0
|
|
Period 1: Double-Blind Treatment Phase
Withdrawal by Subject
|
16
|
12
|
|
Period 1: Double-Blind Treatment Phase
Lack of Efficacy
|
2
|
3
|
|
Period 1: Double-Blind Treatment Phase
Physician Decision
|
0
|
1
|
|
Period 2: Extension Treatment Phase
Adverse Event
|
0
|
8
|
|
Period 2: Extension Treatment Phase
Protocol Violation
|
1
|
0
|
|
Period 2: Extension Treatment Phase
Withdrawal by Subject
|
0
|
9
|
|
Period 2: Extension Treatment Phase
Physician Decision
|
1
|
1
|
|
Period 2: Extension Treatment Phase
Study Terminated by Sponsor
|
1
|
0
|
|
Period 2: Extension Treatment Phase
Lack of Efficacy
|
1
|
1
|
Baseline Characteristics
A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China
Baseline characteristics by cohort
| Measure |
60 mg Duloxetine
n=205 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=202 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.17 years
STANDARD_DEVIATION 8.19 • n=99 Participants
|
59.83 years
STANDARD_DEVIATION 8.40 • n=107 Participants
|
61.14 years
STANDARD_DEVIATION 8.31 • n=206 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
311 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
205 Participants
n=99 Participants
|
202 Participants
n=107 Participants
|
407 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
205 participants
n=99 Participants
|
202 participants
n=107 Participants
|
407 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 13Population: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
60 mg Duloxetine
n=172 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=177 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score
|
-2.23 units on a scale
Standard Error 0.11
|
-1.73 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 13 WeeksPopulation: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
60 mg Duloxetine
n=172 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=177 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Patient Global Impressions of Improvement (PGI-I) Score
|
2.73 units on a scale
Standard Error 0.07
|
3.09 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
WOMAC consists of 24 items divided into 3 subscales:Pain(5 items):during walking,using stairs,in bed,sitting or lying,and standing Stiffness;(2 items):after first waking and later in the day Physical Function;(17 items):stair use,rising from sitting, standing, bending,walking,getting in/out of a car,shopping,putting on/taking off socks,rising from bed,lying in bed,getting in/out of bath,sitting,getting on/off toilet,heavy household duties,light household duties.Each question is answered using a 5-point Likert scale(0 to 4).Pain subscale has a range of scores of 0(none) to 20(extreme).Stiffness subscale has a range of scores of 0(none) to 8(extreme).Physical function subscale has a range of scores of 0(none) to 68(extreme).Total score ranges from 0(none) to 96(extreme).Least squares(LS) mean was calculated using analysis of covariance(ANCOVA) and adjusted for treatment, pooled investigator,and baseline score.Last observation carried forward (LOCF) method was be used for these analyses.
Outcome measures
| Measure |
60 mg Duloxetine
n=184 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=182 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores
Total Score
|
-13.58 units on a scale
Standard Error 0.92
|
-10.09 units on a scale
Standard Error 0.90
|
|
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores
Pain
|
-3.03 units on a scale
Standard Error 0.21
|
-2.32 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores
Physical Function
|
-9.64 units on a scale
Standard Error 0.68
|
-7.28 units on a scale
Standard Error 0.67
|
|
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores
Stiffness
|
-0.83 units on a scale
Standard Error 0.10
|
-0.44 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline,13 WeeksPopulation: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
60 mg Duloxetine
n=172 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=177 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score
|
-0.81 units on a scale
Standard Error 0.05
|
-0.53 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
BPI Severity of Worst Pain is self-reported scale that measures the severity of pain based on the worst pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Least Pain is a self-reported scale that measures the severity of pain based on the least pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Right Now Pain is a self-reported scale that measures the severity of pain based on the pain right now. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
60 mg Duloxetine
n=172 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=177 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) Severity
BPI Severity of Worst Pain
|
-2.71 units on a scale
Standard Error 0.14
|
-2.00 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Brief Pain Inventory (BPI) Severity
BPI Severity of Least Pain
|
-1.48 units on a scale
Standard Error 0.12
|
-1.20 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Brief Pain Inventory (BPI) Severity
BPI Severity of Right Now Pain
|
-2.21 units on a scale
Standard Error 0.14
|
-1.74 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
BPI Interference Average Score is a self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people,sleep, and enjoyment of life.The average Interference scores ranged from 0 to 10. General activity, mood,walking ability, normal work,relations with other people, sleep and enjoyment of life is each is a self-reported scale that measures the interference of pain in the past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.The Interference scores ranged from 0 (does not interfere) to 10 (completely interferes).Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
60 mg Duloxetine
n=172 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=177 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) Interference
BPI Interference Average Score
|
-1.63 units on a scale
Standard Error 0.10
|
-1.36 units on a scale
Standard Error 0.10
|
|
Change From Baseline in Brief Pain Inventory (BPI) Interference
General activity
|
-2.39 units on a scale
Standard Error 0.14
|
-1.83 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Brief Pain Inventory (BPI) Interference
Mood
|
-1.43 units on a scale
Standard Error 0.13
|
-1.04 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Brief Pain Inventory (BPI) Interference
Walking ability
|
-2.35 units on a scale
Standard Error 0.14
|
-1.88 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Brief Pain Inventory (BPI) Interference
Normal work
|
-2.06 units on a scale
Standard Error 0.14
|
-1.76 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Brief Pain Inventory (BPI) Interference
Relations with other people
|
-0.90 units on a scale
Standard Error 0.11
|
-0.84 units on a scale
Standard Error 0.11
|
|
Change From Baseline in Brief Pain Inventory (BPI) Interference
Sleep
|
-1.21 units on a scale
Standard Error 0.14
|
-0.99 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Brief Pain Inventory (BPI) Interference
Enjoyment of life
|
-1.14 units on a scale
Standard Error 0.13
|
-1.07 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale \[0 (low level of anxiety or depression) to 3 (high level of anxiety or depression)\], giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Mean was calculated using analysis of covariance (ANCOVA) and adjusted for treatment, pooled investigator, and baseline score. The last observation carried forward (LOCF) method will be used for these analyses.
Outcome measures
| Measure |
60 mg Duloxetine
n=182 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=182 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores
Depression Subscale
|
-0.10 units on a scale
Standard Error 2.05
|
-0.10 units on a scale
Standard Error 2.12
|
|
Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores
Anxiety Subscale
|
0.02 units on a scale
Standard Error 2.58
|
0.08 units on a scale
Standard Error 2.42
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
Evaluation on whether the change in BPI average pain intensity scores is a direct analgesic effect of duloxetine and is independent of treatment effect on mood, as measured by Hospital Anxiety and Depression Scale (HADS) depression subscale (HADS-D), or anxiety as measured by HADS anxiety subscale (HADS-A). Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.
Outcome measures
| Measure |
60 mg Duloxetine
n=364 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)
HADS-Anxiety subscale score
|
0.05 units on a scale
Standard Deviation 2.50
|
—
|
|
Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)
BPI average pain score
|
-1.91 units on a scale
Standard Deviation 1.52
|
—
|
|
Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)
HADS-Depression subscale score
|
-0.10 units on a scale
Standard Deviation 2.08
|
—
|
SECONDARY outcome
Timeframe: Week 13Population: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) \* 100.The last observation carried forward (LOCF) method will be used for these analyses.
Outcome measures
| Measure |
60 mg Duloxetine
n=194 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=197 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score
Participants with >=30% Reductions
|
63.40 percentage of participants
|
49.70 percentage of participants
|
|
Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score
Participants with >=50% Reductions
|
42.80 percentage of participants
|
34.50 percentage of participants
|
SECONDARY outcome
Timeframe: Week 13Population: All participants who were randomized and had a baseline and at least 1 post-baseline observation.
PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). Response to treatment is defined by endpoint PGI rating of either "much better" or "very much better".The last observation carried forward (LOCF) method will be used for these analyses.
Outcome measures
| Measure |
60 mg Duloxetine
n=194 Participants
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo
n=196 Participants
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|
|
Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
Response to Treatment
|
38.7 percentage of participants
|
20.4 percentage of participants
|
|
Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
1=Very much better
|
3.10 percentage of participants
|
2.60 percentage of participants
|
|
Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
2=Much better
|
35.60 percentage of participants
|
17.90 percentage of participants
|
|
Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
3=A little better
|
40.70 percentage of participants
|
51.00 percentage of participants
|
|
Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
4=The same
|
19.10 percentage of participants
|
23.00 percentage of participants
|
|
Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
5=A little worse
|
1.50 percentage of participants
|
3.60 percentage of participants
|
|
Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
6=Much worse
|
0.00 percentage of participants
|
2.00 percentage of participants
|
|
Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint
7 = Very much worse
|
0.00 percentage of participants
|
0.00 percentage of participants
|
Adverse Events
60 mg Duloxetine Double Blind
Serious events: 0 serious events
Other events: 122 other events
Deaths: 0 deaths
Placebo Double Blind
Serious events: 3 serious events
Other events: 84 other events
Deaths: 0 deaths
60 mg Duloxetine Extention
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo/60 mg Duloxetine Extention
Serious events: 2 serious events
Other events: 81 other events
Deaths: 0 deaths
60 mg Duloxetine Taper
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Taper
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
60 mg Duloxetine Double Blind
n=199 participants at risk
60 mg duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
|
Placebo Double Blind
n=198 participants at risk
Placebo administered by mouth once a day (QD) for 13 weeks.
|
60 mg Duloxetine Extention
n=166 participants at risk
60 mg duloxetine administered by mouth QD for 13 weeks.
|
Placebo/60 mg Duloxetine Extention
n=175 participants at risk
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
|
60 mg Duloxetine Taper
n=323 participants at risk
1-week taper - participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo Taper
n=1 participants at risk
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.31%
1/323 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
Other adverse events
| Measure |
60 mg Duloxetine Double Blind
n=199 participants at risk
60 mg duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
|
Placebo Double Blind
n=198 participants at risk
Placebo administered by mouth once a day (QD) for 13 weeks.
|
60 mg Duloxetine Extention
n=166 participants at risk
60 mg duloxetine administered by mouth QD for 13 weeks.
|
Placebo/60 mg Duloxetine Extention
n=175 participants at risk
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
|
60 mg Duloxetine Taper
n=323 participants at risk
1-week taper - participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
|
Placebo Taper
n=1 participants at risk
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
15.6%
31/199 • Number of events 31
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
5.6%
11/198 • Number of events 11
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.8%
3/166 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
8.6%
15/175 • Number of events 15
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Cardiac disorders
Palpitations
|
1.5%
3/199 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.8%
3/166 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Cardiac disorders
Tachycardia
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Eye disorders
Blindness
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Eye disorders
Eye swelling
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Eye disorders
Vision blurred
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Eye disorders
Visual impairment
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.7%
3/175 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
5/199 • Number of events 7
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.0%
4/198 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.0%
4/198 • Number of events 5
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Abnormal faeces
|
4.0%
8/199 • Number of events 8
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Constipation
|
10.6%
21/199 • Number of events 21
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.5%
5/198 • Number of events 5
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
4.0%
7/175 • Number of events 7
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
3/199 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.5%
3/198 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Face oedema
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Nausea
|
12.1%
24/199 • Number of events 25
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.5%
5/198 • Number of events 5
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
3.0%
5/166 • Number of events 5
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
4.6%
8/175 • Number of events 8
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Retching
|
0.50%
1/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Toothache
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
3/199 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.2%
2/166 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Asthenia
|
2.5%
5/199 • Number of events 6
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Chest discomfort
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Fatigue
|
1.0%
2/199 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Feeling abnormal
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Feeling hot
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Malaise
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Oedema
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Pain
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Pyrexia
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Sensation of foreign body
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Therapeutic response unexpected
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
General disorders
Thirst
|
3.5%
7/199 • Number of events 7
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Infections and infestations
Bronchitis
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.5%
5/198 • Number of events 5
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.7%
3/175 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
4/199 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.0%
4/198 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.5%
3/198 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.2%
2/166 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.31%
1/323 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
3.5%
7/198 • Number of events 8
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
5/199 • Number of events 5
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.5%
3/198 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.8%
3/166 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
5.7%
10/175 • Number of events 12
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.62%
2/323 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
4.6%
8/175 • Number of events 9
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.31%
1/323 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood cholesterol increased
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.31%
1/323 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood glucose increased
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood pressure increased
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood triglycerides increased
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Urine output decreased
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Urine output increased
|
0.50%
1/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Investigations
Weight decreased
|
2.0%
4/199 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.0%
4/198 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.3%
4/175 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.0%
16/199 • Number of events 18
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.5%
3/199 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.5%
3/198 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.7%
3/175 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.62%
2/323 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.0%
4/199 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.2%
2/166 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.62%
2/323 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.5%
3/199 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.2%
2/166 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.7%
3/175 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.31%
1/323 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/154
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/148
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/130
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.78%
1/129 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/243
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Dizziness
|
10.1%
20/199 • Number of events 21
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
4.5%
9/198 • Number of events 11
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.8%
3/166 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
4.0%
7/175 • Number of events 9
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Dreamy state
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Dysgeusia
|
2.5%
5/199 • Number of events 5
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Headache
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.5%
3/198 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Hypoaesthesia
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Mental impairment
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Poor quality sleep
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.0%
4/198 • Number of events 5
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Nervous system disorders
Somnolence
|
14.1%
28/199 • Number of events 31
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
5.1%
10/198 • Number of events 10
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
2.4%
4/166 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
5.7%
10/175 • Number of events 10
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Psychiatric disorders
Abnormal dreams
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Psychiatric disorders
Anxiety
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Psychiatric disorders
Initial insomnia
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Psychiatric disorders
Insomnia
|
5.5%
11/199 • Number of events 11
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Psychiatric disorders
Libido decreased
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Psychiatric disorders
Sleep disorder
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Renal and urinary disorders
Dysuria
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Renal and urinary disorders
Oliguria
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Renal and urinary disorders
Renal cyst
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.2%
1/45 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/50
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/36
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/46
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/80
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
—
0/0
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.2%
1/45 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/50
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/36
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/46
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/80
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
—
0/0
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/154
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.68%
1/148 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/130
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/129
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/243
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/154
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.68%
1/148 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/130
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.78%
1/129 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/243
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.0%
2/199 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Vascular disorders
Flushing
|
0.00%
0/199
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Vascular disorders
Hypertension
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.0%
2/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.8%
3/166 • Number of events 3
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
1.1%
2/175 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Vascular disorders
Hypotension
|
2.0%
4/199 • Number of events 4
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.51%
1/198 • Number of events 2
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/166
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/175
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/323
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
|
Vascular disorders
Orthostatic hypotension
|
0.50%
1/199 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/198
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.60%
1/166 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.57%
1/175 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.31%
1/323 • Number of events 1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
0.00%
0/1
All participants who received at least one dose of study drug. One participant in placebo arm did not receive study drug during the extension period.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60