Trial Outcomes & Findings for A Study in Schizophrenic Patients (NCT NCT01125358)
NCT ID: NCT01125358
Last Updated: 2021-09-14
Results Overview
CUI measures the efficacy (response), tolerability (time on treatment) and safety \[incidence of adverse events (AEs)\] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.
TERMINATED
PHASE2
82 participants
Baseline through Week 6
2021-09-14
Participant Flow
This study consisted of a 1-week placebo lead-in period and a 6-week randomized, double-blind treatment period. Placebo responder is defined as ≥25% improvement in Positive and Negative Syndrome Scale (PANSS) Total Score from the start of placebo lead-in period to the end of placebo lead-in period.
Participant milestones
| Measure |
10 mg LY2140023
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
20
|
20
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
21
|
21
|
20
|
20
|
|
Overall Study
Placebo Responder
|
1
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
9
|
17
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
9
|
8
|
Reasons for withdrawal
| Measure |
10 mg LY2140023
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
2
|
|
Overall Study
Perceived Lack of Efficacy
|
6
|
3
|
7
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
1
|
Baseline Characteristics
A Study in Schizophrenic Patients
Baseline characteristics by cohort
| Measure |
10 mg LY2140023
n=21 Participants
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=21 Participants
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=20 Participants
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
n=20 Participants
Placebo orally, twice daily for 6 weeks.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.99 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
42.03 years
STANDARD_DEVIATION 10.41 • n=7 Participants
|
43.16 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
38.34 years
STANDARD_DEVIATION 9.91 • n=4 Participants
|
41.14 years
STANDARD_DEVIATION 10.38 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
82 participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
17 participants
n=4 Participants
|
68 participants
n=21 Participants
|
|
Region of Enrollment
Korea, Republic of
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 6Population: All participants who received at least 1 dose of study drug and had CUI Total Score measurement at Week 6.
CUI measures the efficacy (response), tolerability (time on treatment) and safety \[incidence of adverse events (AEs)\] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.
Outcome measures
| Measure |
10 mg LY2140023
n=21 Participants
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=21 Participants
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=20 Participants
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Clinical Utility Index (CUI)
|
8.30 units on a scale
Standard Error 0.54
|
10.32 units on a scale
Standard Error 0.52
|
9.27 units on a scale
Standard Error 0.55
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline PANSS measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.
The PANSS consists of 30 items and 3 subscales designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items (range from 30 to 210). The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology Subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\*visit and baseline\*visit.
Outcome measures
| Measure |
10 mg LY2140023
n=19 Participants
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=21 Participants
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=20 Participants
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
n=20 Participants
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale
PANSS Total Score
|
-0.49 units on a scale
Interval -12.37 to 11.4
|
-2.56 units on a scale
Interval -12.32 to 7.2
|
1.40 units on a scale
Interval -9.64 to 12.44
|
9.35 units on a scale
Interval -1.8 to 20.51
|
|
Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale
PANSS Positive Subscore (n=19, 21, 20, 20)
|
0.33 units on a scale
Interval -2.8 to 3.45
|
-2.30 units on a scale
Interval -4.9 to 0.3
|
-0.05 units on a scale
Interval -2.93 to 2.82
|
1.93 units on a scale
Interval -1.0 to 4.85
|
|
Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale
PANSS Negative Subscore
|
0.23 units on a scale
Interval -3.2 to 3.67
|
-0.22 units on a scale
Interval -3.03 to 2.58
|
0.33 units on a scale
Interval -2.84 to 3.5
|
2.70 units on a scale
Interval -0.5 to 5.9
|
|
Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale
PANSS General Psychopathology Subscore
|
-0.88 units on a scale
Interval -7.05 to 5.3
|
-0.31 units on a scale
Interval -5.35 to 4.72
|
1.18 units on a scale
Interval -4.59 to 6.94
|
4.79 units on a scale
Interval -1.03 to 10.6
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline CGI-S measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.
The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\*visit and baseline\*visit.
Outcome measures
| Measure |
10 mg LY2140023
n=19 Participants
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=21 Participants
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=20 Participants
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
n=20 Participants
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)
|
0.62 units on a scale
Interval -0.11 to 1.34
|
-0.49 units on a scale
Interval -1.09 to 0.11
|
0.14 units on a scale
Interval -0.52 to 0.81
|
-0.25 units on a scale
Interval -0.93 to 0.42
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline NSA-16 Total Score measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.
The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\*visit and baseline\*visit.
Outcome measures
| Measure |
10 mg LY2140023
n=13 Participants
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=17 Participants
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=14 Participants
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
n=13 Participants
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16)
|
3.42 units on a scale
Interval -3.38 to 10.22
|
-0.40 units on a scale
Interval -6.41 to 5.6
|
-6.31 units on a scale
Interval -13.16 to 0.53
|
-1.22 units on a scale
Interval -7.76 to 5.33
|
SECONDARY outcome
Timeframe: Baseline up to Week 6Population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline C-SSRS measurements.
Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide. The number of participants with statistically significant changes of the C-SSRS was the number of participants with a treatment-emergent suicidal ideation and behavior (an increase in suicidal behavior or ideation over lead-in baseline.)
Outcome measures
| Measure |
10 mg LY2140023
n=20 Participants
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=21 Participants
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=20 Participants
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
n=20 Participants
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-Emergent Suicidal Ideation
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-Emergent Suicidal Behavior
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 6Population: All randomized participants who received at least 1 dose of study drug.
Rate of discontinuation was calculated as the number of participants who discontinued from study due to any reason divided by the total number of participants who received study drug, then multiplied by 100.
Outcome measures
| Measure |
10 mg LY2140023
n=21 Participants
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=21 Participants
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=20 Participants
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
n=20 Participants
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Discontinued (Rate of Discontinuation)
|
57.1 percentage of participants
|
19.0 percentage of participants
|
45.0 percentage of participants
|
40.0 percentage of participants
|
Adverse Events
10 mg LY2140023
80 mg LY2140023
160 mg LY2140023
Placebo
Serious adverse events
| Measure |
10 mg LY2140023
n=21 participants at risk
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=21 participants at risk
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=20 participants at risk
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
n=20 participants at risk
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Nervous system disorders
Psychomotor hyperactivity
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/21
|
9.5%
2/21 • Number of events 2
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
Other adverse events
| Measure |
10 mg LY2140023
n=21 participants at risk
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.
|
80 mg LY2140023
n=21 participants at risk
40 mg of LY2140023 orally, twice daily for 6 weeks.
|
160 mg LY2140023
n=20 participants at risk
80 mg of LY2140023 orally, twice daily for 6 weeks.
|
Placebo
n=20 participants at risk
Placebo orally, twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Eye disorders
Visual impairment
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2
|
14.3%
3/21 • Number of events 3
|
10.0%
2/20 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Oral disorder
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Stomatitis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1
|
19.0%
4/21 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Malaise
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
15.0%
3/20 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Infections and infestations
Tinea pedis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
1/21 • Number of events 1
|
4.8%
1/21 • Number of events 2
|
0.00%
0/20
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Joint injury
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Blood prolactin increased
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Investigations
Blood uric acid increased
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Weight decreased
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/21
|
9.5%
2/21 • Number of events 2
|
5.0%
1/20 • Number of events 2
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • Number of events 3
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Nervous system disorders
Somnolence
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Nervous system disorders
Tremor
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Affect lability
|
4.8%
1/21 • Number of events 2
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Affective disorder
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Agitation
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Delusion
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Depression
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Hallucination
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Psychiatric disorders
Schizophrenia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Vascular disorders
Hot flush
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/20
|
0.00%
0/20
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60