Trial Outcomes & Findings for An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia (NCT NCT00784875)
NCT ID: NCT00784875
Last Updated: 2012-02-29
Results Overview
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
643 participants
Primary outcome timeframe
Baseline, 2 weeks
Results posted on
2012-02-29
Participant Flow
LY2624803 was placed on clinical hold by Food and Drug Administration (FDA) on 18 December 2008. The FDA lifted the clinical hold effective 05 May 2009. For analysis purposes, participants who entered into study during 2008 were designated as Cohort 1, whereas participants who entered into study after 2008 were designated as Cohort 2.
None of Cohort 1 participants completed the study and few progressed beyond Period B. The efficacy analyses were conducted using data from Cohort 2 participants only. Participant flow includes participants from both cohorts.
Participant milestones
| Measure |
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
|
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
|
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
|
Placebo
Participants received placebo in a 2-week treatment period.
|
|---|---|---|---|---|
|
Period A - Baseline
STARTED
|
0
|
0
|
0
|
643
|
|
Period A - Baseline
COMPLETED
|
0
|
0
|
0
|
461
|
|
Period A - Baseline
NOT COMPLETED
|
0
|
0
|
0
|
182
|
|
Period B - Efficacy Endpoint
STARTED
|
114
|
113
|
117
|
117
|
|
Period B - Efficacy Endpoint
Cohort 2
|
102
|
102
|
102
|
101
|
|
Period B - Efficacy Endpoint
COMPLETED
|
100
|
101
|
96
|
98
|
|
Period B - Efficacy Endpoint
NOT COMPLETED
|
14
|
12
|
21
|
19
|
|
Period C
STARTED
|
103
|
97
|
97
|
98
|
|
Period C
COMPLETED
|
96
|
91
|
84
|
91
|
|
Period C
NOT COMPLETED
|
7
|
6
|
13
|
7
|
|
Period D
STARTED
|
91
|
89
|
94
|
88
|
|
Period D
COMPLETED
|
86
|
85
|
88
|
87
|
|
Period D
NOT COMPLETED
|
5
|
4
|
6
|
1
|
Reasons for withdrawal
| Measure |
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
|
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
|
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
|
Placebo
Participants received placebo in a 2-week treatment period.
|
|---|---|---|---|---|
|
Period A - Baseline
Entry Criteria Not Met
|
0
|
0
|
0
|
5
|
|
Period A - Baseline
Adverse Event
|
0
|
0
|
0
|
8
|
|
Period A - Baseline
Protocol Violation
|
0
|
0
|
0
|
25
|
|
Period A - Baseline
Withdrawal by Subject
|
0
|
0
|
0
|
27
|
|
Period A - Baseline
Physician Decision
|
0
|
0
|
0
|
2
|
|
Period A - Baseline
Sponsor Decision
|
0
|
0
|
0
|
113
|
|
Period A - Baseline
Lost to Follow-up
|
0
|
0
|
0
|
2
|
|
Period B - Efficacy Endpoint
Entry Criteria Not Met
|
0
|
0
|
2
|
1
|
|
Period B - Efficacy Endpoint
Adverse Event
|
0
|
3
|
2
|
1
|
|
Period B - Efficacy Endpoint
Protocol Violation
|
1
|
1
|
2
|
3
|
|
Period B - Efficacy Endpoint
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Period B - Efficacy Endpoint
Withdrawal by Subject
|
4
|
1
|
1
|
2
|
|
Period B - Efficacy Endpoint
Physician Decision
|
0
|
0
|
1
|
0
|
|
Period B - Efficacy Endpoint
Sponsor Decision
|
9
|
6
|
12
|
12
|
|
Period B - Efficacy Endpoint
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Period C
Adverse Event
|
1
|
0
|
4
|
2
|
|
Period C
Protocol Violation
|
0
|
0
|
1
|
2
|
|
Period C
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
Period C
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
|
Period C
Physician Decision
|
0
|
0
|
1
|
1
|
|
Period C
Sponsor Decision
|
5
|
5
|
4
|
2
|
|
Period D
Adverse Event
|
0
|
2
|
2
|
0
|
|
Period D
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Period D
Withdrawal by Subject
|
2
|
0
|
2
|
0
|
|
Period D
Physician Decision
|
0
|
1
|
0
|
0
|
|
Period D
Sponsor Decision
|
1
|
1
|
1
|
0
|
|
Period D
Lost to Follow-up
|
1
|
0
|
1
|
1
|
Baseline Characteristics
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
Baseline characteristics by cohort
| Measure |
LY2624803 1 mg
n=102 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=102 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=102 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=101 Participants
Participants received placebo in Period B (2-week treatment period).
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
52.81 years
STANDARD_DEVIATION 14.07 • n=5 Participants
|
52.77 years
STANDARD_DEVIATION 14.73 • n=7 Participants
|
50.65 years
STANDARD_DEVIATION 15 • n=5 Participants
|
52.86 years
STANDARD_DEVIATION 13.66 • n=4 Participants
|
52.27 years
STANDARD_DEVIATION 14.35 • n=21 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
240 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
167 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
75 participants
n=5 Participants
|
74 participants
n=7 Participants
|
85 participants
n=5 Participants
|
72 participants
n=4 Participants
|
306 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
12 participants
n=5 Participants
|
18 participants
n=4 Participants
|
72 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
102 participants
n=7 Participants
|
102 participants
n=5 Participants
|
101 participants
n=4 Participants
|
407 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Outcome measures
| Measure |
LY2624803 1 mg
n=102 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=102 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=102 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=101 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
|
30.16 minutes
Standard Error 5.300
|
37.33 minutes
Standard Error 5.186
|
50.63 minutes
Standard Error 5.186
|
22.79 minutes
Standard Error 5.153
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Unwanted time awake (minutes awake \[MA\] before sleep \[between turning off the lights to first falling asleep\], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.
Outcome measures
| Measure |
LY2624803 1 mg
n=102 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=102 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=102 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=101 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
Before Sleep (n= 101, 101, 101, 101)
|
-7.08 minutes
Standard Error 2.524
|
-6.45 minutes
Standard Error 2.444
|
-20.48 minutes
Standard Error 2.440
|
-1.46 minutes
Standard Error 2.420
|
|
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
During Sleep (n= 101, 102, 101, 101)
|
-14.84 minutes
Standard Error 2.881
|
-12.95 minutes
Standard Error 2.812
|
-21.46 minutes
Standard Error 2.819
|
-8.23 minutes
Standard Error 2.794
|
|
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
After Sleep (n= 100, 101, 99, 99)
|
-9.07 minutes
Standard Error 2.150
|
-8.31 minutes
Standard Error 2.108
|
-4.91 minutes
Standard Error 2.119
|
-5.05 minutes
Standard Error 2.105
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Outcome measures
| Measure |
LY2624803 1 mg
n=102 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=102 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=102 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=101 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint
|
-0.27 number of awakenings
Standard Error 0.066
|
-0.26 number of awakenings
Standard Error 0.065
|
-0.59 number of awakenings
Standard Error 0.065
|
-0.18 number of awakenings
Standard Error 0.065
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Outcome measures
| Measure |
LY2624803 1 mg
n=102 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=102 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=102 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=101 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint
|
-28.63 minutes
Standard Error 4.678
|
-28.62 minutes
Standard Error 4.591
|
-47.28 minutes
Standard Error 4.579
|
-13.09 minutes
Standard Error 4.547
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Outcome measures
| Measure |
LY2624803 1 mg
n=102 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=102 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=102 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=101 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint
|
0.06 ratio
Standard Error 0.009
|
0.06 ratio
Standard Error 0.009
|
0.10 ratio
Standard Error 0.009
|
0.03 ratio
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Outcome measures
| Measure |
LY2624803 1 mg
n=102 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=102 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=102 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=101 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Total Score
|
0.17 units on a scale
Standard Error 0.035
|
0.17 units on a scale
Standard Error 0.034
|
0.25 units on a scale
Standard Error 0.034
|
0.13 units on a scale
Standard Error 0.034
|
|
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Feeling upon Awakening Subscale
|
0.14 units on a scale
Standard Error 0.034
|
0.13 units on a scale
Standard Error 0.033
|
0.19 units on a scale
Standard Error 0.033
|
0.12 units on a scale
Standard Error 0.033
|
|
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Sleep Experience Subscale
|
0.22 units on a scale
Standard Error 0.042
|
0.24 units on a scale
Standard Error 0.042
|
0.35 units on a scale
Standard Error 0.042
|
0.15 units on a scale
Standard Error 0.041
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Outcome measures
| Measure |
LY2624803 1 mg
n=100 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=99 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=96 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=97 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint
|
-1.23 units on a scale
Standard Error 0.395
|
-0.87 units on a scale
Standard Error 0.385
|
-1.20 units on a scale
Standard Error 0.394
|
-0.73 units on a scale
Standard Error 0.386
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Outcome measures
| Measure |
LY2624803 1 mg
n=99 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=96 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=95 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=94 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint
|
-2.85 units on a scale
Standard Error 0.587
|
-2.83 units on a scale
Standard Error 0.578
|
-4.63 units on a scale
Standard Error 0.582
|
-1.95 units on a scale
Standard Error 0.574
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary)
Outcome measures
| Measure |
LY2624803 1 mg
n=97 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=95 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=94 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=92 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint
Physical Component Scores
|
-2.32 units on a scale
Standard Error 1.001
|
-0.28 units on a scale
Standard Error 0.987
|
-0.82 units on a scale
Standard Error 0.992
|
-1.84 units on a scale
Standard Error 0.991
|
|
Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint
Mental Component Scores
|
2.49 units on a scale
Standard Error 1.198
|
1.11 units on a scale
Standard Error 1.181
|
1.21 units on a scale
Standard Error 1.191
|
1.94 units on a scale
Standard Error 1.184
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Outcome measures
| Measure |
LY2624803 1 mg
n=98 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=95 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=94 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=93 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint
|
-3.06 units on a scale
Standard Error 1.525
|
-2.56 units on a scale
Standard Error 1.503
|
-1.71 units on a scale
Standard Error 1.510
|
0.23 units on a scale
Standard Error 1.503
|
SECONDARY outcome
Timeframe: Baseline (Period A) and 2 weeks (Period B)Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.
Outcome measures
| Measure |
LY2624803 1 mg
n=99 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=96 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=95 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=94 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Treatment Satisfaction as Measured by the Participant Drug Preference Question
Period A Treatment (placebo)
|
23.2 percentage of participants
|
22.9 percentage of participants
|
12.6 percentage of participants
|
35.1 percentage of participants
|
|
Treatment Satisfaction as Measured by the Participant Drug Preference Question
Period B Treatment
|
76.8 percentage of participants
|
77.1 percentage of participants
|
87.4 percentage of participants
|
64.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.
Outcome measures
| Measure |
LY2624803 1 mg
n=102 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=102 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=102 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=99 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
1 - Very much improved
|
8.8 percentage of participants
|
9.8 percentage of participants
|
15.7 percentage of participants
|
5.1 percentage of participants
|
|
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
2 - Much improved
|
20.6 percentage of participants
|
23.5 percentage of participants
|
34.3 percentage of participants
|
18.2 percentage of participants
|
|
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
3 - Minimally improved
|
45.1 percentage of participants
|
37.3 percentage of participants
|
30.4 percentage of participants
|
33.3 percentage of participants
|
|
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
4 - No change
|
21.6 percentage of participants
|
28.4 percentage of participants
|
16.7 percentage of participants
|
40.4 percentage of participants
|
|
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
5 - Minimally Worse
|
2.0 percentage of participants
|
0 percentage of participants
|
1.0 percentage of participants
|
3.0 percentage of participants
|
|
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
6 - Much worse
|
2.0 percentage of participants
|
1.0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
|
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
7 - Very much worse
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.
Outcome measures
| Measure |
LY2624803 1 mg
n=99 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=96 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=95 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=94 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
1 - Very much improved
|
0 percentage of participants
|
2.1 percentage of participants
|
4.2 percentage of participants
|
3.2 percentage of participants
|
|
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
2 - Much improved
|
11.1 percentage of participants
|
16.7 percentage of participants
|
20.0 percentage of participants
|
9.6 percentage of participants
|
|
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
3 - Minimally improved
|
62.6 percentage of participants
|
45.8 percentage of participants
|
55.8 percentage of participants
|
42.6 percentage of participants
|
|
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
4 - No change
|
24.2 percentage of participants
|
31.3 percentage of participants
|
15.8 percentage of participants
|
37.2 percentage of participants
|
|
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
5 - Minimally worse
|
1.0 percentage of participants
|
2.1 percentage of participants
|
4.2 percentage of participants
|
6.4 percentage of participants
|
|
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
6 - Much worse
|
0 percentage of participants
|
1.0 percentage of participants
|
0 percentage of participants
|
1.1 percentage of participants
|
|
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
7 - Very much worse
|
1.0 percentage of participants
|
1.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 8 weeksPopulation: Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.
Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 8 weeksPopulation: Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.
Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 8 weeksPopulation: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.
Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
LY2624803 1 mg
n=114 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=113 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=117 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=117 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Period B (n= 114, 113, 117, 117)
|
28 participants
|
18 participants
|
33 participants
|
21 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Period C (n= 103, 97, 97, 98)
|
26 participants
|
34 participants
|
42 participants
|
22 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Period D (n= 91, 89, 94, 88)
|
29 participants
|
35 participants
|
34 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Baseline through 8 weeksPopulation: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.
SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
LY2624803 1 mg
n=114 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=113 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=117 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=117 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks of treatment over 8 weeksPopulation: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Outcome measures
| Measure |
LY2624803 1 mg
n=114 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=113 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=117 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=117 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Period B: DBP (n= 112, 111, 117, 117)
|
0.15 mmHg
Standard Error 0.607
|
0.21 mmHg
Standard Error 0.610
|
-0.45 mmHg
Standard Error 0.594
|
-0.41 mmHg
Standard Error 0.594
|
|
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Period B: SBP (n= 112, 111, 117, 117)
|
0.83 mmHg
Standard Error 0.908
|
0.91 mmHg
Standard Error 0.912
|
-0.05 mmHg
Standard Error 0.888
|
-0.37 mmHg
Standard Error 0.888
|
|
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Period C: DBP (n= 102, 97, 97, 97)
|
0.35 mmHg
Standard Error 0.675
|
1.11 mmHg
Standard Error 0.693
|
-0.68 mmHg
Standard Error 0.693
|
-0.51 mmHg
Standard Error 0.693
|
|
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Period C: SBP (n= 102, 97, 97, 97)
|
2.31 mmHg
Standard Error 0.932
|
1.54 mmHg
Standard Error 0.960
|
0.68 mmHg
Standard Error 0.957
|
0.58 mmHg
Standard Error 0.958
|
|
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Period D: DBP (n= 91, 89, 93, 88)
|
0.33 mmHg
Standard Error 0.751
|
-0.31 mmHg
Standard Error 0.760
|
0.37 mmHg
Standard Error 0.743
|
0.75 mmHg
Standard Error 0.764
|
|
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Period D: SBP (n= 91, 89, 93, 88)
|
0.03 mmHg
Standard Error 1.097
|
1.17 mmHg
Standard Error 1.109
|
0.87 mmHg
Standard Error 1.085
|
2.39 mmHg
Standard Error 1.118
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks of treatment over 8 weeksPopulation: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Outcome measures
| Measure |
LY2624803 1 mg
n=114 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=113 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=117 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=117 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
Period B (n= 112, 111, 117, 117)
|
0.65 beats per minute
Standard Error 0.664
|
0.95 beats per minute
Standard Error 0.669
|
0.41 beats per minute
Standard Error 0.653
|
0.62 beats per minute
Standard Error 0.649
|
|
Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
Period C (n= 102, 97, 97, 97)
|
0.42 beats per minute
Standard Error 0.758
|
0.94 beats per minute
Standard Error 0.777
|
-0.64 beats per minute
Standard Error 0.777
|
-0.02 beats per minute
Standard Error 0.777
|
|
Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
Period D (n= 91, 89, 93, 88)
|
0.48 beats per minute
Standard Error 0.813
|
-0.36 beats per minute
Standard Error 0.820
|
1.49 beats per minute
Standard Error 0.803
|
1.40 beats per minute
Standard Error 0.826
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks of treatment over 8 weeksPopulation: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Outcome measures
| Measure |
LY2624803 1 mg
n=114 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=113 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=117 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=117 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Weight at Each 2-week Treatment Endpoint
Period B (n= 111, 111, 115, 114)
|
0.13 kilogram
Standard Error 0.105
|
0.27 kilogram
Standard Error 0.105
|
-0.08 kilogram
Standard Error 0.103
|
0.06 kilogram
Standard Error 0.104
|
|
Change From Baseline in Weight at Each 2-week Treatment Endpoint
Period C (n= 104, 100, 97, 96)
|
0.03 kilogram
Standard Error 0.129
|
0.30 kilogram
Standard Error 0.132
|
-0.07 kilogram
Standard Error 0.135
|
0.09 kilogram
Standard Error 0.134
|
|
Change From Baseline in Weight at Each 2-week Treatment Endpoint
Period D (n=91, 90, 93, 88)
|
0.12 kilogram
Standard Error 0.164
|
0.17 kilogram
Standard Error 0.165
|
0.08 kilogram
Standard Error 0.162
|
0.03 kilogram
Standard Error 0.166
|
SECONDARY outcome
Timeframe: 2 weeks of treatment over 8 weeksPopulation: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had endpoint value. For LY2624803 1 mg, LY2624803 3 mg, Zolpidem 5 or 10 mg, and Placebo, the Number of Participants Analyzed were as follows: Period B: N=114, 113,117, 117; Period C: N=103, 97, 97, 98; and Period D: N=91, 89, 94, 88.
Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).
Outcome measures
| Measure |
LY2624803 1 mg
n=114 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=113 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=117 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=117 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Blood Urea Nitrogen
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Hemoglobin
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Creatinine
|
3 participants
|
0 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Glucose, Non-fasting or random
|
4 participants
|
5 participants
|
1 participants
|
5 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Alkaline Phosphatase
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Alanine Transaminase
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Aspartate Transaminase
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Total Bilirubin
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Creatine Phosphokinase
|
1 participants
|
3 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Creatinine
|
3 participants
|
1 participants
|
4 participants
|
5 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Glucose, Non-fasting or random
|
6 participants
|
4 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Blood Urea Nitrogen
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Hemoglobin
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Leukocyte Count
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period B: Platelet Count
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Alkaline Phosphatase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Alanine Transaminase
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Aspartate Transaminase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Total Bilirubin
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Creatine Phosphokinase
|
3 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Leukocyte Count
|
2 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period C: Platelet Count
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Alkaline Phosphatase
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Alanine Transaminase
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Aspartate Transaminase
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Total Bilirubin
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Creatine Phosphokinase
|
2 participants
|
2 participants
|
5 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Creatinine
|
1 participants
|
4 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Glucose, Non-fasting or random
|
6 participants
|
2 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Blood Urea Nitrogen
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Hemoglobin
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Leukocyte Count
|
1 participants
|
2 participants
|
3 participants
|
5 participants
|
|
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Period D: Platelet Count
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks of treatment over 8 weeksPopulation: All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Outcome measures
| Measure |
LY2624803 1 mg
n=114 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=113 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=117 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=117 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Period B (n= 112, 110, 115, 112)
|
1.09 beats per minute
Standard Error 0.689
|
0.26 beats per minute
Standard Error 0.695
|
1.10 beats per minute
Standard Error 0.681
|
0.30 beats per minute
Standard Error 0.688
|
|
Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Period C (n= 99, 94, 96, 95)
|
-0.59 beats per minute
Standard Error 0.734
|
0.31 beats per minute
Standard Error 0.753
|
-0.02 beats per minute
Standard Error 0.745
|
1.14 beats per minute
Standard Error 0.749
|
|
Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Period D (n= 91,86, 93, 87)
|
1.71 beats per minute
Standard Error 0.827
|
1.71 beats per minute
Standard Error 0.851
|
1.43 beats per minute
Standard Error 0.818
|
0.86 beats per minute
Standard Error 0.846
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks of treatment over 8 weeksPopulation: All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Outcome measures
| Measure |
LY2624803 1 mg
n=114 Participants
Participants received LY2624803 1 mg in Period B (2-week treatment period).
|
LY2624803 3 mg
n=113 Participants
Participants received LY2624803 3 mg in Period B (2-week treatment period).
|
Zolpidem 5 or 10 mg
n=117 Participants
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Placebo
n=117 Participants
Participants received placebo in Period B (2-week treatment period).
|
|---|---|---|---|---|
|
Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Period B (n= 112, 110, 115, 112)
|
-0.04 milliseconds
Standard Error 1.314
|
-2.62 milliseconds
Standard Error 1.325
|
-1.02 milliseconds
Standard Error 1.300
|
-1.43 milliseconds
Standard Error 1.316
|
|
Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Period C (n= 99, 94, 96, 95)
|
-1.07 milliseconds
Standard Error 1.335
|
-0.41 milliseconds
Standard Error 1.373
|
-3.27 milliseconds
Standard Error 1.356
|
-3.92 milliseconds
Standard Error 1.370
|
|
Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Period D (n= 91, 86, 93, 87)
|
-2.00 milliseconds
Standard Error 1.319
|
-2.99 milliseconds
Standard Error 1.344
|
-3.59 milliseconds
Standard Error 1.293
|
-1.68 milliseconds
Standard Error 1.339
|
Adverse Events
Period B - LY2624803 1 mg
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Period B - LY2624803 3 mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Period B - Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Period B - Zolpidem 5 or 10 mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Period C - LY2624803 1 mg
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Period C - LY2624803 3 mg
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Period C - Placebo
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Period C - Zolpidem 5 or 10 mg
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Period D - LY2624803 1 mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Period D - LY2624803 3 mg
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Period D - Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Period D - Zolpidem 5 or 10 mg
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period B - LY2624803 1 mg
n=114 participants at risk
Patients received LY2624803 1 mg in Period B (2-week treatment period.
|
Period B - LY2624803 3 mg
n=113 participants at risk
Patients received LY2624803 3 mg in Period B (2-week treatment period).
|
Period B - Placebo
n=117 participants at risk
Patients received placebo in Period B (2-week treatment period).
|
Period B - Zolpidem 5 or 10 mg
n=117 participants at risk
Patients received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Period C - LY2624803 1 mg
n=103 participants at risk
Patients received LY2624803 1 mg in Period C (2-week treatment period.
|
Period C - LY2624803 3 mg
n=97 participants at risk
Patients received LY2624803 3 mg in Period C (2-week treatment period).
|
Period C - Placebo
n=98 participants at risk
Patients received placebo in Period C (2-week treatment period).
|
Period C - Zolpidem 5 or 10 mg
n=97 participants at risk
Patients received Zolpidem 5 or 10 mg in Period C (2-week treatment period).
|
Period D - LY2624803 1 mg
n=91 participants at risk
Patients received LY2624803 1 mg in Period D (2-week treatment period.
|
Period D - LY2624803 3 mg
n=89 participants at risk
Patients received LY2624803 3 mg in Period D (2-week treatment period).
|
Period D - Placebo
n=88 participants at risk
Patients received placebo in Period D (2-week treatment period).
|
Period D - Zolpidem 5 or 10 mg
n=94 participants at risk
Patients received Zolpidem 5 or 10 mg in Period D (2-week treatment period).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
Other adverse events
| Measure |
Period B - LY2624803 1 mg
n=114 participants at risk
Patients received LY2624803 1 mg in Period B (2-week treatment period.
|
Period B - LY2624803 3 mg
n=113 participants at risk
Patients received LY2624803 3 mg in Period B (2-week treatment period).
|
Period B - Placebo
n=117 participants at risk
Patients received placebo in Period B (2-week treatment period).
|
Period B - Zolpidem 5 or 10 mg
n=117 participants at risk
Patients received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
|
Period C - LY2624803 1 mg
n=103 participants at risk
Patients received LY2624803 1 mg in Period C (2-week treatment period.
|
Period C - LY2624803 3 mg
n=97 participants at risk
Patients received LY2624803 3 mg in Period C (2-week treatment period).
|
Period C - Placebo
n=98 participants at risk
Patients received placebo in Period C (2-week treatment period).
|
Period C - Zolpidem 5 or 10 mg
n=97 participants at risk
Patients received Zolpidem 5 or 10 mg in Period C (2-week treatment period).
|
Period D - LY2624803 1 mg
n=91 participants at risk
Patients received LY2624803 1 mg in Period D (2-week treatment period.
|
Period D - LY2624803 3 mg
n=89 participants at risk
Patients received LY2624803 3 mg in Period D (2-week treatment period).
|
Period D - Placebo
n=88 participants at risk
Patients received placebo in Period D (2-week treatment period).
|
Period D - Zolpidem 5 or 10 mg
n=94 participants at risk
Patients received Zolpidem 5 or 10 mg in Period D (2-week treatment period).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.8%
2/113 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.1%
3/98 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Reproductive system and breast disorders
Uterine spasm
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/89 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
General disorders
Feeling abnormal
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Eye disorders
Eye discharge
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Eye disorders
Eye pain
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/89 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
2/114 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.1%
3/97 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.4%
3/89 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.3%
2/88 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
General disorders
Fatigue
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.1%
3/97 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
General disorders
Feeling jittery
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
General disorders
Irritability
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.7%
2/117 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.0%
2/98 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/94 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
General disorders
Pain
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
General disorders
Sluggishness
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
General disorders
Suprapubic pain
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Immune system disorders
Seasonal allergy
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Gastroenteritis
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Influenza
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/94 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.7%
2/117 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.7%
2/117 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/89 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.4%
3/88 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Otitis media
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.9%
2/103 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.1%
3/97 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
4.4%
4/91 • Number of events 4 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.4%
3/89 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/94 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Investigations
Blood pressure increased
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Investigations
Heart rate increased
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/91 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/94 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.3%
2/88 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.4%
4/117 • Number of events 4 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
4.1%
4/97 • Number of events 4 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/91 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/89 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.9%
2/103 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Headache
|
3.5%
4/114 • Number of events 6 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.6%
3/117 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.7%
2/117 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.9%
3/103 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.0%
2/98 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
4.1%
4/97 • Number of events 4 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/89 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.3%
2/88 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
6.4%
6/94 • Number of events 6 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/91 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Paraesthesia
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.7%
2/117 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.9%
2/103 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Sedation
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.7%
2/117 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.3%
3/91 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Somnolence
|
1.8%
2/114 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.7%
2/117 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
4.3%
5/117 • Number of events 5 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.9%
4/103 • Number of events 4 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
6.2%
6/97 • Number of events 6 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.1%
3/98 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
7.2%
7/97 • Number of events 7 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
7.7%
7/91 • Number of events 7 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/89 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
3.4%
3/88 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
4.3%
4/94 • Number of events 4 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Abnormal dreams
|
1.8%
2/114 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/89 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/94 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.1%
2/97 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Sleep inertia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Psychiatric disorders
Suicidal ideation
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
2/114 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.6%
3/117 • Number of events 3 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.9%
2/103 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/91 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/89 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/91 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/114 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.88%
1/113 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/103 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/97 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/94 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Social circumstances
Postmenopause
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.85%
1/117 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/98 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/89 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.1%
1/88 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
|
Vascular disorders
Hypertension
|
0.88%
1/114 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/113 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/117 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.97%
1/103 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
1.0%
1/98 • Number of events 1 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/97 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/91 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
2.2%
2/89 • Number of events 2 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/88 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
0.00%
0/94 • Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
|
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