Trial Outcomes & Findings for A Study of Safety and Tolerability in Subjects With Schizophrenia (NCT NCT01354353)
NCT ID: NCT01354353
Last Updated: 2022-09-14
Results Overview
Participants with at least 1 postdose (Day 10 through the end of study visit \[Day 21\]) treatment emergent adverse event (TEAE) were counted by dose cohort. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
75 participants
Primary outcome timeframe
Baseline up to Day 21 for Part A
Results posted on
2022-09-14
Participant Flow
This was a 2-part study. The lead-in period was from Days 1 to 9, the test dosing (treatment) period was from Days 10 to 16, and the follow-up period was from Days 17 to 21. Dose escalation in Part A was completed. Part B (dose titration) was optional and not initiated because the objective of the study was met in Part A.
Participant milestones
| Measure |
Aripiprazole
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
240 mg LY2140023
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
12
|
11
|
12
|
12
|
12
|
|
Overall Study
Received at Least One Dose of Study Drug
|
16
|
11
|
10
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
13
|
11
|
9
|
7
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
5
|
1
|
6
|
Reasons for withdrawal
| Measure |
Aripiprazole
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
240 mg LY2140023
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
4
|
0
|
5
|
|
Overall Study
Entry Criteria Not Met
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Safety and Tolerability in Subjects With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=16 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=12 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=11 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=12 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=12 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=12 Participants
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 10 • n=5 Participants
|
50 years
STANDARD_DEVIATION 7 • n=7 Participants
|
49 years
STANDARD_DEVIATION 8 • n=5 Participants
|
45 years
STANDARD_DEVIATION 10 • n=4 Participants
|
42 years
STANDARD_DEVIATION 13 • n=21 Participants
|
46 years
STANDARD_DEVIATION 10 • n=10 Participants
|
45 years
STANDARD_DEVIATION 10 • n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
57 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
70 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
52 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
12 participants
n=10 Participants
|
75 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 21 for Part APopulation: Participants who were assigned to treatment and were either dosed or discontinued prior to dosing.
Participants with at least 1 postdose (Day 10 through the end of study visit \[Day 21\]) treatment emergent adverse event (TEAE) were counted by dose cohort. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=12 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=11 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=12 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=12 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=12 Participants
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)
Days 10-16
|
5 participants
|
6 participants
|
9 participants
|
11 participants
|
11 participants
|
11 participants
|
|
Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)
Follow-up (Days 17-20)
|
4 participants
|
2 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)
End of Study (Day 21)
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose on Day 10 and Day 16Population: Participants who received at least one dose of LY2140023 with evaluable Cmax data.
Outcome measures
| Measure |
Aripiprazole
n=6 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=12 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=12 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=12 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics, Maximum Concentration (Cmax)
Day 10 (single dose)
|
496 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 65
|
1170 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
1410 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
1830 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
2630 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
—
|
|
Part A: Pharmacokinetics, Maximum Concentration (Cmax)
Day 16 (multiple doses)
|
799 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
1090 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
1510 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
1760 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
1810 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose on Days 12, 15, 18, 21, and 24Population: Zero participants were analyzed.
Part B (dose titration as defined in Part B of study) was not conducted because the objective of the study was met in part A.; therefore, no data are available for analysis of this secondary outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and post-dose on Day 10 and Day 16Population: Participants who received at least one dose of LY2140023 with evaluable AUC data.
The Day 10 parameter is area under the concentration versus time curve from time zero to infinity (AUC\[0-inf\]) post-single dose of LY2140023. The Day 16 parameter is area under the concentration versus time curve in a dosing interval (AUC\[0-tau\]) post-repeated daily doses of LY2140023.
Outcome measures
| Measure |
Aripiprazole
n=6 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=12 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=12 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=12 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
Day 10 (single dose) (n=5, 7, 9, 9, 6)
|
2800 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 46
|
6290 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 50
|
8100 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
10600 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 23
|
14700 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 11
|
—
|
|
Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
Day 16 (multiple doses) (n=4, 9, 7, 11, 4)
|
4370 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 21
|
6220 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32
|
7930 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 39
|
9890 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
10100 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose on Days 12, 15, 18, 21, and 24Population: Zero participants were analyzed.
Part B of this study was not conducted; therefore, no data are available for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Day 17 for Part APopulation: Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Clinical Global Impression- Severity Scale data.
Clinical Global Impression- Severity Scale (CGI-S) measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The classification includes 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, and 7 = Among the most extremely ill patients. Increases or higher scores indicate increasing severity (=worse outcome) Only incidences of selected shifts of increasing severity (an increase in numbers on a scale) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=10 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=11 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=11 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=11 Participants
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S)
Shift from Mild to Moderate
|
6.3 percentage of participants with shifts
|
9.1 percentage of participants with shifts
|
20.0 percentage of participants with shifts
|
0 percentage of participants with shifts
|
18.2 percentage of participants with shifts
|
9.1 percentage of participants with shifts
|
|
Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S)
Shift From Borderline to Mild
|
0 percentage of participants with shifts
|
0 percentage of participants with shifts
|
0 percentage of participants with shifts
|
9.1 percentage of participants with shifts
|
0 percentage of participants with shifts
|
0 percentage of participants with shifts
|
SECONDARY outcome
Timeframe: Baseline through Day 17 for Part APopulation: Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Brief Psychiatric Rating Scale data.
Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a participant's general psychopathological symptoms. Item scores ranged from 0 (not assessed) to 7 (extremely severe). Total Scores ranged from 0 to 126. Increases or higher scores indicate a worsening of symptoms. Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the 18-symptom construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=10 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=11 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=11 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=11 Participants
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
Mild to moderately severe - Hallucinatory behavior
|
12.5 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
Very mild to moderate - Unusual thought content
|
6.3 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
Very mild to moderate - Excitement
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
10.0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
Very mild to moderate - Conceptual disorganization
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
Mild to moderately severe - Anxiety
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
10.0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
SECONDARY outcome
Timeframe: Baseline through Day 17 for Part APopulation: Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Abnormal Involuntary Movement Scale data.
The Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Increases or higher scores indicate a worsening of symptoms. The classification includes 0 = None, 1 = Minimal, may be extreme normal, 2 = Mild, 3 = Moderate, and 4 - Severe. Only incidences of selected shifts of worsening severity (an increase in numbers on a scale within the 10-item construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=10 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=11 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=11 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=11 Participants
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)
Normal to Minimal - Jaw
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)
Normal to Minimal - Muscles of facial expression
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
SECONDARY outcome
Timeframe: Baseline through Day 17 for Part APopulation: Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Simpson-Angus Scale data.
Simpson-Angus Scale (SAS) is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. The scale consists of 10 items each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items. Increases or higher scores indicate a worsening of impairment. Only incidences of selected shifts of increasing impairment (an increase in numbers on a scale within the 10-symptom construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=10 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=11 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=11 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=11 Participants
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
Normal to Slight - Gait
|
6.3 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
Normal to Slight - Head dropping
|
6.3 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
Normal to Slight - Tremor
|
12.5 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
10.0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
|
Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
Normal to Slight - Salivation
|
6.3 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
Normal to Slight - Glabella tap
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
SECONDARY outcome
Timeframe: Baseline through Day 17 for Part APopulation: Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Barnes Akathisia Scale data.
Barnes Akathisia Rating Scale (BAS) evaluates observable, restless movements of drug-induced akathisia associated with use of antipsychotic medications, includes objective (1-item) and subjective component (2-items, awareness of movement and distress related to movement) plus Global Clinical Assessment for overall disorder. Components were rated on a 4-point scale for the objective (0 = normal and 3 = constantly restless) and subjective items ((0 = absence of inner restlessness and 3 = awareness of intense compulsion to move for one item; and 0 = no distress and 3 = severe for the other item) and scored on a 6-point scale for the Global Clinical Assessment (0 = absent and 5 = severe). Increases or higher scores indicate a worsening of symptoms. Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the components) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 Participants
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=10 Participants
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=11 Participants
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=11 Participants
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=11 Participants
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)
Objective - Normal to presence restless movements
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
10.0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)
Subjective - Awareness - Absence to non-specific
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
10.0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)
Subjective - Distress - No distress to mild
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
10.0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
|
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)
Global - Absent to questionable
|
6.3 Percentage of participants with shifts
|
0 Percentage of participants with shifts
|
10.0 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
9.1 Percentage of participants with shifts
|
Adverse Events
Aripiprazole
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
160 mg LY2140023
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
240 mg LY2140023
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
320 mg LY2140023
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
400 mg LY2140023
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
480 mg LY2140023
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole
n=16 participants at risk
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 participants at risk
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=10 participants at risk
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=11 participants at risk
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=11 participants at risk
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=11 participants at risk
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/9
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/9
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
11.1%
1/9 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/9
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
Other adverse events
| Measure |
Aripiprazole
n=16 participants at risk
Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams \[mg\]/day) from Study Day 1 to Study Day 21 (discharge).
|
160 mg LY2140023
n=11 participants at risk
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
|
240 mg LY2140023
n=10 participants at risk
240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
320 mg LY2140023
n=11 participants at risk
320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
400 mg LY2140023
n=11 participants at risk
400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
480 mg LY2140023
n=11 participants at risk
480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
27.3%
3/11 • Number of events 3
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
80.0%
8/10 • Number of events 9
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
54.5%
6/11 • Number of events 9
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
36.4%
4/11 • Number of events 4
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
63.6%
7/11 • Number of events 13
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
50.0%
5/10 • Number of events 5
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
54.5%
6/11 • Number of events 11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
27.3%
3/11 • Number of events 8
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
81.8%
9/11 • Number of events 36
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
General disorders
Asthenia
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
General disorders
Energy increased
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
General disorders
Fatigue
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
General disorders
Feeling cold
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
General disorders
Feeling hot
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Investigations
Blood pressure increased
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Investigations
Electroencephalogram abnormal
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Akathisia
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
50.0%
5/10 • Number of events 6
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
54.5%
6/11 • Number of events 10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
54.5%
6/11 • Number of events 10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
72.7%
8/11 • Number of events 8
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Drooling
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Dyskinesia
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Dystonia
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Headache
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
30.0%
3/10 • Number of events 4
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
36.4%
4/11 • Number of events 4
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Sedation
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 3
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Somnolence
|
12.5%
2/16 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
20.0%
2/10 • Number of events 3
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
27.3%
3/11 • Number of events 3
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Syncope
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Psychiatric disorders
Anticipatory anxiety
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
10.0%
1/10 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/7
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/3
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
66.7%
2/3 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.2%
1/16 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
40.0%
4/10 • Number of events 4
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
18.2%
2/11 • Number of events 7
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 2
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Vascular disorders
Flushing
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
|
Vascular disorders
Hot flush
|
0.00%
0/16
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/10
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
9.1%
1/11 • Number of events 1
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
0.00%
0/11
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
|
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