Trial Outcomes & Findings for One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome (NCT NCT01113541)

Last Updated: 2021-03-03

Results Overview

MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm \[men\] and ≥80 cm \[women\]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter \[mg/dL\]); reduced high-density lipoprotein cholesterol (HDL-C): \<1.03 mmol/L (\<40 mg/dL) in men and \<1.3 mmol/L (\<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

13 participants

Primary outcome timeframe

Week 52 or Early Termination

Results posted on

2021-03-03

Participant Flow

Twenty-seven participants were screened for the study and 13 participants were assigned to study drug and treated.

Participant milestones

Participant milestones
Measure	Ziprasidone Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Ziprasidone Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1
Overall Study Study Terminated by Sponsor	7
Overall Study Adverse Event	4

Baseline Characteristics

One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ziprasidone n=13 Participants Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Age, Continuous	46.5 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52 or Early Termination

Population: Per protocol population: all subjects in the intent-to-treat population who remained in the study for at least 28 weeks. N = number of participants with analyzable data at observation.

Outcome measures

Outcome measures
Measure	Ziprasidone n=10 Participants Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation	50.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: PP and Intent-to-treat (ITT) population; ITT population = all participants enrolled in the study who received at least 1 dose of study medication and who had baseline and at least 1 post-baseline MS measurement. Results not reported: data not summarized due to limited enrollment and early termination of the study.

MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm \[men\] and ≥80 cm \[women\]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: \<1.03 mmol/L (\<40 mg/dL) in men and \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm \[men\] and ≥80 cm \[women\]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: \<1.03 mmol/L (\<40 mg/dL) in men and \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm \[men\] and ≥80 cm \[women\]).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

MS risk factor reduced HDL-C defined as \<1.03 millimoles per liter (mmol/L) (\<40 mg/dL) in men and \<1.3 mmol/L (\<50 mg/dL) in women.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 52

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range \<0 to ≥25, higher score indicates higher 10 year risk (range \<1% to ≥30% 10 year risk).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 52 or Early Termination

Population: PP and ITT. Median was reported due to small sample size and risk of skewing.

Outcome measures

Outcome measures
Measure	Ziprasidone n=10 Participants Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels Total cholesterol: Baseline	206.0 milligrams per deciliter Interval 138.61 to 269.884
Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels Total cholesterol: Change at Last Observation	-20.0 milligrams per deciliter Interval -47.104 to 18.919
Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels LDL cholesterol: Baseline	131.0 milligrams per deciliter Interval 78.764 to 167.567
Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels LDL cholesterol: Change at Last Observation	-8.0 milligrams per deciliter Interval -36.68 to 16.988

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 52 or Early Termination

Population: PP and ITT; n = number of participants with evaluable data at observation.

Outcome measures

Outcome measures
Measure	Ziprasidone n=13 Participants Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Change From Baseline in Weight Value at Week 12 (n=5)	97.3 kilograms Standard Deviation 25.37
Change From Baseline in Weight Value at Week 52 (n=10)	87.5 kilograms Standard Deviation 24.50
Change From Baseline in Weight Baseline (n=13)	93.5 kilograms Standard Deviation 23.12
Change From Baseline in Weight Value at Week 4 (n=9)	92.9 kilograms Standard Deviation 21.99

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 52 or Early Termination

Population: PP and ITT. Results for BMI not reported: data not summarized due to limited enrollment and early termination of the study.

Body mass index = weight in kilograms (kg) / height in meters (m)\^2 .

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 52 or Early Termination

Population: PP and ITT. Median was reported due to small sample size and risk of skewing. Last observation = last observation while on study drug or during the lag.

Outcome measures

Outcome measures
Measure	Ziprasidone n=10 Participants Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Baseline	5.5 percent HbA1c Interval 5.3 to 6.1
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Median change	-0.2 percent HbA1c Interval -0.3 to 0.1

SECONDARY outcome

Timeframe: Baseline, Week 52 or Early Termination

Population: PP and ITT. Insulin levels not reported: data not summarized due to limited enrollment and early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 52 or Early Termination

Population: PP and ITT; n = number of participants with analyzable data at observation.

QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR\^1/3, where RR=RR interval in seconds.

Outcome measures

Outcome measures
Measure	Ziprasidone n=13 Participants Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF) Baseline (n=13)	421.0 milliseconds Standard Deviation 12.16
Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF) Week 4 (n=9)	434.0 milliseconds Standard Deviation 13.61
Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF) Week 52 or or Early Termination (n=9)	428.8 milliseconds Standard Deviation 14.65

SECONDARY outcome

Timeframe: Baseline, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 28, Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 52 or Early Termination

Population: PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.

C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.

Outcome measures

Outcome data not reported

Adverse Events

Ziprasidone

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ziprasidone n=13 participants at risk Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Nervous system disorders Akathisia	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Ziprasidone n=13 participants at risk Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
Ear and labyrinth disorders Vertigo	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	38.5% 5/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Non-cardiac chest pain	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Thirst	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory infection	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood cholesterol increased	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood prolactin increased	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations High density lipoprotein decreased	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Low density lipoprotein increased	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Protein urine present	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in jaw	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Akathisia	23.1% 3/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Disturbance in attention	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	38.5% 5/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Memory impairment	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sedation	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	30.8% 4/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tension headache	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Agitation	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Confusional state	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Emotional disorder	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Flat affect	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Hypomania	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	46.2% 6/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Mania	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicidal ideation	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Terminal insomnia	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Menstruation irregular	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER