Trial Outcomes & Findings for A Study for Treatment of Pain in Patients With Diabetic Neuropathy. (NCT NCT00785577)
NCT ID: NCT00785577
Last Updated: 2012-05-31
Results Overview
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
273 participants
Primary outcome timeframe
Baseline, 5 weeks
Results posted on
2012-05-31
Participant Flow
Study Period 1 was an up to 5-week screening phase when participants stopped use of excluded medications (525 participants entered; 252 discontinued ). Study Period 2 was a 5-week, double-blind therapy period when randomization and dispensing of study drug occurred. Study Period 3 was a 1-week washout phase when all study medication was stopped.
Participant milestones
| Measure |
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
|
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
|
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Study Period 2: Therapy Phase
STARTED
|
89
|
45
|
43
|
49
|
47
|
|
Study Period 2: Therapy Phase
COMPLETED
|
78
|
36
|
25
|
36
|
27
|
|
Study Period 2: Therapy Phase
NOT COMPLETED
|
11
|
9
|
18
|
13
|
20
|
|
Study Period 3: 1-Week Washout Phase
STARTED
|
78
|
36
|
25
|
36
|
27
|
|
Study Period 3: 1-Week Washout Phase
COMPLETED
|
78
|
36
|
25
|
35
|
26
|
|
Study Period 3: 1-Week Washout Phase
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
|
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
|
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Study Period 2: Therapy Phase
Adverse Event
|
5
|
7
|
14
|
10
|
17
|
|
Study Period 2: Therapy Phase
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Study Period 2: Therapy Phase
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Study Period 2: Therapy Phase
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Study Period 2: Therapy Phase
Protocol Violation
|
1
|
1
|
1
|
0
|
1
|
|
Study Period 2: Therapy Phase
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
1
|
|
Study Period 2: Therapy Phase
Entry Criteria Exclusion
|
1
|
0
|
1
|
1
|
0
|
|
Study Period 2: Therapy Phase
Sponsor Decision
|
1
|
0
|
1
|
1
|
0
|
|
Study Period 3: 1-Week Washout Phase
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Study Period 3: 1-Week Washout Phase
Death
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study for Treatment of Pain in Patients With Diabetic Neuropathy.
Baseline characteristics by cohort
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
Pregabalin
n=45 Participants
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
|
LY545694 21 mg
n=43 Participants
LY545694 21 milligrams (mg) BID po for 1 week.
|
LY545694 49 mg
n=49 Participants
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
55.32 years
STANDARD_DEVIATION 10.00 • n=93 Participants
|
56.89 years
STANDARD_DEVIATION 8.19 • n=4 Participants
|
56.95 years
STANDARD_DEVIATION 8.35 • n=27 Participants
|
58.59 years
STANDARD_DEVIATION 7.71 • n=483 Participants
|
56.47 years
STANDARD_DEVIATION 7.77 • n=36 Participants
|
56.62 years
STANDARD_DEVIATION 8.71 • n=10 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
118 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
155 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
7 participants
n=93 Participants
|
4 participants
n=4 Participants
|
2 participants
n=27 Participants
|
4 participants
n=483 Participants
|
2 participants
n=36 Participants
|
19 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
2 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
4 participants
n=483 Participants
|
8 participants
n=36 Participants
|
37 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
1 participants
n=36 Participants
|
4 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
71 participants
n=93 Participants
|
35 participants
n=4 Participants
|
30 participants
n=27 Participants
|
40 participants
n=483 Participants
|
35 participants
n=36 Participants
|
211 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=93 Participants
|
29 participants
n=4 Participants
|
28 participants
n=27 Participants
|
29 participants
n=483 Participants
|
28 participants
n=36 Participants
|
171 participants
n=10 Participants
|
|
Region of Enrollment
Mexico
|
26 participants
n=93 Participants
|
13 participants
n=4 Participants
|
12 participants
n=27 Participants
|
16 participants
n=483 Participants
|
16 participants
n=36 Participants
|
83 participants
n=10 Participants
|
|
Region of Enrollment
Puerto Rico
|
6 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
4 participants
n=483 Participants
|
3 participants
n=36 Participants
|
19 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=78 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=26 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=35 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks
|
-2.08 units on a scale
Standard Error 0.22
|
-2.22 units on a scale
Standard Error 0.36
|
-2.45 units on a scale
Standard Error 0.32
|
-2.42 units on a scale
Standard Error 0.33
|
—
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=78 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=35 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks
|
-2.31 units on a scale
Standard Error 0.23
|
-2.75 units on a scale
Standard Error 0.33
|
-2.25 units on a scale
Standard Error 0.37
|
-2.54 units on a scale
Standard Error 0.33
|
-2.21 units on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=78 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=35 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks
|
-2.27 units on a scale
Standard Error 0.25
|
-2.87 units on a scale
Standard Error 0.35
|
-2.57 units on a scale
Standard Error 0.40
|
-2.77 units on a scale
Standard Error 0.35
|
-2.67 units on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.
This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=42 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=48 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score
|
38 participants
|
18 participants
|
21 participants
|
21 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=79 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=37 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks
|
-2.73 units on a scale
Standard Error 0.25
|
-2.81 units on a scale
Standard Error 0.34
|
-2.31 units on a scale
Standard Error 0.39
|
-2.73 units on a scale
Standard Error 0.34
|
-2.30 units on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=79 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=37 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S Worst Pain
|
-2.57 units on a scale
Standard Error 0.29
|
-3.54 units on a scale
Standard Error 0.40
|
-3.49 units on a scale
Standard Error 0.47
|
-2.94 units on a scale
Standard Error 0.41
|
-3.13 units on a scale
Standard Error 0.44
|
|
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S Least Pain
|
-1.76 units on a scale
Standard Error 0.26
|
-2.44 units on a scale
Standard Error 0.35
|
-1.99 units on a scale
Standard Error 0.40
|
-2.09 units on a scale
Standard Error 0.36
|
-1.54 units on a scale
Standard Error 0.38
|
|
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S Average Pain
|
-2.08 units on a scale
Standard Error 0.26
|
-2.92 units on a scale
Standard Error 0.36
|
-2.79 units on a scale
Standard Error 0.41
|
-2.50 units on a scale
Standard Error 0.36
|
-2.25 units on a scale
Standard Error 0.38
|
|
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S Current Pain
|
-2.44 units on a scale
Standard Error 0.28
|
-3.06 units on a scale
Standard Error 0.38
|
-2.66 units on a scale
Standard Error 0.44
|
-2.98 units on a scale
Standard Error 0.39
|
-2.51 units on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=79 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=37 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks
|
-1.07 units on a scale
Standard Error 0.11
|
-1.02 units on a scale
Standard Error 0.15
|
-1.28 units on a scale
Standard Error 0.18
|
-1.07 units on a scale
Standard Error 0.15
|
-1.03 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 5Population: The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.
PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=79 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=37 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks
|
2.58 units on a scale
Standard Error 0.13
|
2.28 units on a scale
Standard Error 0.18
|
2.37 units on a scale
Standard Error 0.20
|
2.63 units on a scale
Standard Error 0.18
|
2.41 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=79 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=36 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks
|
-8.20 units on a scale
Standard Error 0.73
|
-8.60 units on a scale
Standard Error 1.01
|
-8.93 units on a scale
Standard Error 1.20
|
-8.95 units on a scale
Standard Error 1.02
|
-7.89 units on a scale
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.
Outcome measures
| Measure |
Placebo
n=78 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=35 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=32 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks
|
0.76 units on a scale
Standard Error 0.08
|
0.88 units on a scale
Standard Error 0.11
|
0.67 units on a scale
Standard Error 0.13
|
0.51 units on a scale
Standard Error 0.12
|
0.55 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5-point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3-point bothersome/importance scale (1=none to 3=very).
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=40 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=45 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=44 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks
|
-0.56 units on a scale
Standard Error 0.11
|
-0.49 units on a scale
Standard Error 0.15
|
-0.58 units on a scale
Standard Error 0.16
|
-0.59 units on a scale
Standard Error 0.15
|
-0.31 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.
Outcome measures
| Measure |
Placebo
n=88 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=40 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=45 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=44 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks
|
7.51 units on a scale
Standard Error 0.94
|
10.70 units on a scale
Standard Error 1.26
|
8.16 units on a scale
Standard Error 1.32
|
5.78 units on a scale
Standard Error 1.24
|
6.33 units on a scale
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Outcome measures
| Measure |
Placebo
n=88 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=40 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=45 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=44 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score
|
0.09 units on a scale
Standard Error 0.02
|
0.09 units on a scale
Standard Error 0.02
|
0.11 units on a scale
Standard Error 0.02
|
0.05 units on a scale
Standard Error 0.02
|
0.07 units on a scale
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=88 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=40 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=44 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=44 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks
|
-2.96 units on a scale
Standard Error 0.70
|
-2.58 units on a scale
Standard Error 0.94
|
-2.63 units on a scale
Standard Error 0.99
|
-1.97 units on a scale
Standard Error 0.95
|
-3.04 units on a scale
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: The safety analysis population included all 273 participants randomized to study drug.
Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=43 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=49 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase
Therapy (Double-blind) Phase
|
5 participants
|
7 participants
|
14 participants
|
10 participants
|
17 participants
|
|
Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase
1-Week Washout (Follow-up) Phase
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The safety analysis population included all 273 participants randomized to study drug.
The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the "Investigations" system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=43 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=49 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values
Alanine aminotransferase (ALT) abnormal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values
Aspartate aminotransferase (AST) abnormal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=79 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=37 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks
Systolic Blood Pressure (mmHg)
|
-1.82 millimeters of mercury (mmHg)
Standard Error 1.37
|
-3.18 millimeters of mercury (mmHg)
Standard Error 1.93
|
0.22 millimeters of mercury (mmHg)
Standard Error 2.26
|
-0.24 millimeters of mercury (mmHg)
Standard Error 1.96
|
0.08 millimeters of mercury (mmHg)
Standard Error 2.10
|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks
Diastolic Blood Pressure (mmHg)
|
-0.87 millimeters of mercury (mmHg)
Standard Error 0.88
|
-3.60 millimeters of mercury (mmHg)
Standard Error 1.25
|
-0.07 millimeters of mercury (mmHg)
Standard Error 1.46
|
1.88 millimeters of mercury (mmHg)
Standard Error 1.26
|
0.77 millimeters of mercury (mmHg)
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=79 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=37 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks
|
-1.06 beats per minute (bpm)
Standard Error 1.05
|
-3.60 beats per minute (bpm)
Standard Error 1.49
|
0.87 beats per minute (bpm)
Standard Error 1.72
|
1.47 beats per minute (bpm)
Standard Error 1.51
|
1.66 beats per minute (bpm)
Standard Error 1.61
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
The number of participants having QTcF and QTcB change ≥ 30 msec was summarized.
Outcome measures
| Measure |
Placebo
n=78 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=41 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=36 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=42 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=36 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas
QTcF ≥30 msec
|
3 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas
QTcB ≥30 msec
|
4 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The safety analysis population included all 273 participants randomized to study drug.
Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the "Investigations" system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=43 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=49 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Reported Hypoglycemic Events
|
1.12 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
2.13 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=43 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=49 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score
|
-1.96 units on a scale
Standard Error 0.22
|
-1.49 units on a scale
Standard Error 0.31
|
-0.69 units on a scale
Standard Error 0.34
|
-0.46 units on a scale
Standard Error 0.31
|
0.20 units on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline through week 5Population: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a "yes" answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation.
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=43 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=49 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Number of Participants With Suicidal Behaviors and Ideations
Suicidal behaviors
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Behaviors and Ideations
Suicidal ideations
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 5Population: The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.
This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read.
Outcome measures
| Measure |
Placebo
n=79 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=37 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=26 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=35 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=30 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks
YES
|
8 participants
|
8 participants
|
3 participants
|
3 participants
|
4 participants
|
|
Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks
NO
|
71 participants
|
29 participants
|
23 participants
|
32 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.
Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.
Outcome measures
| Measure |
Placebo
n=115 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=118 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)
|
79.1 Liters per hour (L/hr)
Interval 68.7 to 91.9
|
39.8 Liters per hour (L/hr)
Interval 35.8 to 44.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported.
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=42 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=48 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Time to Response
|
36 time (days)
|
30 time (days)
|
30 time (days)
|
30 time (days)
|
30 time (days)
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The safety analysis population included all 273 participants randomized to study drug.
The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the "Nervous system disorders" system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Placebo
n=89 Participants
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
|
LY545694 21 mg
n=45 Participants
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
|
LY545694 49 mg
n=43 Participants
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=49 Participants
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
|---|---|---|---|---|---|
|
Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)
|
17 participants
|
22 participants
|
16 participants
|
24 participants
|
23 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
LY545694 21 mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
LY545694 49 mg
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
LY545694 105 mg
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Pregabalin
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo Washout
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
LY545694 21 mg Washout
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY545694 49 mg Washout
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
LY545694 105 mg Washout
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Pregabalin Washout
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=89 participants at risk
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks
|
LY545694 21 mg
n=43 participants at risk
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week
|
LY545694 49 mg
n=49 participants at risk
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=47 participants at risk
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
Pregabalin
n=45 participants at risk
Pregabalin thrice daily (TID) oral (po) for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
|
Placebo Washout
n=89 participants at risk
A one-week washout period in which no placebo was taken.
|
LY545694 21 mg Washout
n=43 participants at risk
A one-week washout period in which no LY545694 21 mg was taken.
|
LY545694 49 mg Washout
n=49 participants at risk
A one-week washout period in which no LY545694 49 mg was taken.
|
LY545694 105 mg Washout
n=47 participants at risk
A one-week washout period in which no LY545694 105 mg was taken.
|
Pregabalin Washout
n=45 participants at risk
A one-week washout period in which no pregabalin was taken.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Aspartate aminotransferase abnormal
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Dizziness
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
Other adverse events
| Measure |
Placebo
n=89 participants at risk
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks
|
LY545694 21 mg
n=43 participants at risk
LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week
|
LY545694 49 mg
n=49 participants at risk
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
|
LY545694 105 mg
n=47 participants at risk
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
|
Pregabalin
n=45 participants at risk
Pregabalin thrice daily (TID) oral (po) for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
|
Placebo Washout
n=89 participants at risk
A one-week washout period in which no placebo was taken.
|
LY545694 21 mg Washout
n=43 participants at risk
A one-week washout period in which no LY545694 21 mg was taken.
|
LY545694 49 mg Washout
n=49 participants at risk
A one-week washout period in which no LY545694 49 mg was taken.
|
LY545694 105 mg Washout
n=47 participants at risk
A one-week washout period in which no LY545694 105 mg was taken.
|
Pregabalin Washout
n=45 participants at risk
A one-week washout period in which no pregabalin was taken.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Initial insomnia
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
14.3%
7/49 • Number of events 7
|
12.8%
6/47 • Number of events 6
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Nightmare
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Abnormal dreams
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Agitation
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Apathy
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Depressed mood
|
2.2%
2/89 • Number of events 2
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
Psychiatric disorders
Depression
|
0.00%
0/89
|
0.00%
0/43
|
4.1%
2/49 • Number of events 2
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Elevated mood
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Left ventricular hypertrophy
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Cardiac disorders
Palpitations
|
1.1%
1/89 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
4.1%
2/49 • Number of events 3
|
6.4%
3/47 • Number of events 3
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Blepharitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Blepharospasm
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Dry eye
|
2.2%
2/89 • Number of events 2
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Macular oedema
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Ocular hyperaemia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Phosphenes
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Photophobia
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Retinal exudates
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
Retinopathy
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Uveitis
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Vision blurred
|
2.2%
2/89 • Number of events 2
|
9.3%
4/43 • Number of events 4
|
4.1%
2/49 • Number of events 2
|
8.5%
4/47 • Number of events 4
|
6.7%
3/45 • Number of events 3
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Eye disorders
Visual impairment
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/89 • Number of events 3
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
2/89 • Number of events 2
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/89 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
2.1%
1/47 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
7/89 • Number of events 8
|
7.0%
3/43 • Number of events 3
|
8.2%
4/49 • Number of events 4
|
4.3%
2/47 • Number of events 2
|
4.4%
2/45 • Number of events 3
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
4.3%
2/47 • Number of events 2
|
4.4%
2/45 • Number of events 2
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/89
|
2.3%
1/43 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.4%
3/89 • Number of events 3
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Nausea
|
12.4%
11/89 • Number of events 12
|
27.9%
12/43 • Number of events 14
|
30.6%
15/49 • Number of events 17
|
25.5%
12/47 • Number of events 14
|
4.4%
2/45 • Number of events 2
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
4/89 • Number of events 4
|
14.0%
6/43 • Number of events 7
|
24.5%
12/49 • Number of events 13
|
17.0%
8/47 • Number of events 11
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Asthenia
|
0.00%
0/89
|
0.00%
0/43
|
6.1%
3/49 • Number of events 5
|
4.3%
2/47 • Number of events 4
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
General disorders
Chills
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
General disorders
Fatigue
|
2.2%
2/89 • Number of events 2
|
2.3%
1/43 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
4.3%
2/47 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
General disorders
Feeling cold
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
General disorders
Feeling jittery
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Gait disturbance
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
6.4%
3/47 • Number of events 3
|
2.2%
1/45 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Irritability
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
General disorders
Malaise
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
General disorders
Oedema peripheral
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
13.3%
6/45 • Number of events 6
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
General disorders
Pain
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
General disorders
Temperature intolerance
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Hepatobiliary disorders
Liver disorder
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Immune system disorders
Food allergy
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Bronchitis
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Cystitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Gastroenteritis bacterial
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Herpes simplex
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Influenza
|
3.4%
3/89 • Number of events 3
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Localised infection
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
2/89 • Number of events 2
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Sinusitis
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Tooth abscess
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Urinary tract infection
|
3.4%
3/89 • Number of events 3
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
2.2%
2/89 • Number of events 2
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Viral infection
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Wound infection
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 2
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood bicarbonate abnormal
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood bicarbonate increased
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood bilirubin increased
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood calcium increased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
4.3%
2/47 • Number of events 3
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood creatinine increased
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood glucose decreased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood glucose increased
|
2.2%
2/89 • Number of events 2
|
4.7%
2/43 • Number of events 2
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood pressure increased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Blood urea increased
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Electrocardiogram poor r-wave progression
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Electrocardiogram qrs complex prolonged
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Glucose urine present
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Grip strength decreased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Haemoglobin decreased
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Heart rate increased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Liver function test abnormal
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Monofilament pressure perception test abnormal
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Neurological examination abnormal
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Qrs axis abnormal
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Red blood cell sedimentation rate increased
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Rheumatoid factor increased
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Weight decreased
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Investigations
Weight increased
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
8.9%
4/45 • Number of events 4
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
2/89 • Number of events 2
|
9.3%
4/43 • Number of events 4
|
18.4%
9/49 • Number of events 9
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
3/89 • Number of events 3
|
4.7%
2/43 • Number of events 2
|
10.2%
5/49 • Number of events 5
|
6.4%
3/47 • Number of events 3
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.2%
2/89 • Number of events 2
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 3
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
8.9%
4/45 • Number of events 4
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Salt craving
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
4/89 • Number of events 4
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/89
|
0.00%
0/43
|
6.1%
3/49 • Number of events 4
|
6.4%
3/47 • Number of events 3
|
2.2%
1/45 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
4.4%
2/45 • Number of events 2
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
2/89 • Number of events 2
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Ataxia
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/89
|
7.0%
3/43 • Number of events 3
|
4.1%
2/49 • Number of events 2
|
0.00%
0/47
|
6.7%
3/45 • Number of events 3
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Decreased vibratory sense
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Disturbance in attention
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
6.4%
3/47 • Number of events 3
|
6.7%
3/45 • Number of events 3
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Dizziness
|
2.2%
2/89 • Number of events 2
|
11.6%
5/43 • Number of events 5
|
16.3%
8/49 • Number of events 8
|
10.6%
5/47 • Number of events 8
|
8.9%
4/45 • Number of events 4
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Headache
|
12.4%
11/89 • Number of events 13
|
2.3%
1/43 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
8.5%
4/47 • Number of events 4
|
4.4%
2/45 • Number of events 2
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Hypersomnia
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
6.4%
3/47 • Number of events 3
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
2/89 • Number of events 2
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
6.4%
3/47 • Number of events 3
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Hyporeflexia
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Lethargy
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Memory impairment
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Narcolepsy
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Paraesthesia
|
1.1%
1/89 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/89
|
4.7%
2/43 • Number of events 2
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Sensory disturbance
|
1.1%
1/89 • Number of events 2
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Sensory loss
|
1.1%
1/89 • Number of events 4
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Somnolence
|
1.1%
1/89 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
10.2%
5/49 • Number of events 5
|
6.4%
3/47 • Number of events 3
|
20.0%
9/45 • Number of events 10
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Syncope
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Nervous system disorders
Tremor
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
20.4%
10/49 • Number of events 11
|
14.9%
7/47 • Number of events 9
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Sleep disorder
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Suicidal ideation
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Bladder sphincter atony
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/89
|
4.7%
2/43 • Number of events 2
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Polyuria
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/89
|
4.7%
2/43 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
4.1%
2/49 • Number of events 2
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Hyperoxia
|
0.00%
0/89
|
0.00%
0/43
|
4.1%
2/49 • Number of events 2
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Pleural rub
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/89
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.1%
1/89 • Number of events 2
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/89 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Surgical and medical procedures
Debridement
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Surgical and medical procedures
Renal stone removal
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Surgical and medical procedures
Skin graft
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
2.2%
1/45 • Number of events 1
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Surgical and medical procedures
Tumour excision
|
1.1%
1/89 • Number of events 1
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Vascular disorders
Hot flush
|
0.00%
0/89
|
0.00%
0/43
|
2.0%
1/49 • Number of events 1
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
|
Vascular disorders
Hypertension
|
0.00%
0/89
|
0.00%
0/43
|
4.1%
2/49 • Number of events 2
|
6.4%
3/47 • Number of events 3
|
0.00%
0/45
|
0.00%
0/89
|
0.00%
0/43
|
0.00%
0/49
|
0.00%
0/47
|
0.00%
0/45
|
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