Trial Outcomes & Findings for Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed) (NCT NCT00265330)
NCT ID: NCT00265330
Last Updated: 2021-03-25
Results Overview
YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
169 participants
Primary outcome timeframe
baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)
Results posted on
2021-03-25
Participant Flow
The number of subjects entering this trial was determined by the number of subjects electing to continue treatment after completing or withdrawing from the preceding double-blind study (A1281132: NCT00257166).
A total of 169 subjects from the parent study were assigned to the extension study and 162 continued on and received study treatment in the extension study.
Participant milestones
| Measure |
Ziprasidone
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Overall Study
STARTED
|
162
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
95
|
Reasons for withdrawal
| Measure |
Ziprasidone
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Overall Study
Adverse Event
|
41
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Withdrawal by Subject
|
34
|
|
Overall Study
Patient Wanted to Start Psychotherapy
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Family Scheduling Conflicts
|
1
|
|
Overall Study
Began Taking Formulary Geodon
|
1
|
|
Overall Study
Discharged from Unit for Long Term Care
|
1
|
|
Overall Study
Site Closed by Sponsor
|
1
|
|
Overall Study
Principal Investigators Request
|
1
|
|
Overall Study
Withdrew Consent
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Baseline characteristics by cohort
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Age, Continuous
|
13.3 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)Population: The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)
YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Young Mania Rating Scale (YMRS) Total Score Change From Baseline
Week 2 (n=153)
|
-3.8 score on scale
Standard Deviation 9.0
|
|
Young Mania Rating Scale (YMRS) Total Score Change From Baseline
Week 6 (n=122)
|
-4.0 score on scale
Standard Deviation 9.1
|
|
Young Mania Rating Scale (YMRS) Total Score Change From Baseline
Week 18 (n=76)
|
-6.3 score on scale
Standard Deviation 12.7
|
|
Young Mania Rating Scale (YMRS) Total Score Change From Baseline
Week 26 (n=69)
|
-6.1 score on scale
Standard Deviation 11.6
|
|
Young Mania Rating Scale (YMRS) Total Score Change From Baseline
Early Termination (n=59)
|
1.5 score on scale
Standard Deviation 11.3
|
|
Young Mania Rating Scale (YMRS) Total Score Change From Baseline
Week 26-LOCF (n=153)
|
-3.3 score on scale
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: baseline and 26 Weeks; 26 Weeks LOCFPopulation: The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)
CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 1 (n=159)
|
-0.2 score on scale
Standard Deviation 0.9
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 2 (n=150)
|
-0.5 score on scale
Standard Deviation 1.2
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 6 (n=122)
|
-0.4 score on scale
Standard Deviation 1.1
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 10 (n=99)
|
-0.7 score on scale
Standard Deviation 1.3
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 14 (n=85)
|
-0.7 score on scale
Standard Deviation 1.2
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 18 (n=76)
|
-0.7 score on scale
Standard Deviation 1.5
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 22 (n=70)
|
-0.8 score on scale
Standard Deviation 1.3
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 26 (n=69)
|
-1.1 score on scale
Standard Deviation 1.4
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Early Termination (n=48)
|
0.4 score on scale
Standard Deviation 1.1
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Week 26-LOCF (n=160)
|
-0.4 score on scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Week 26Population: Total number of subjects with given laboratory test at given visit. Range: N=136-134, with the exception of Insulin (N=115)
number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.
Outcome measures
| Measure |
Ziprasidone
n=136 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
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|---|---|
|
Incidence of Lab Abnormalities
Bicarbonate (N=136)
|
44 participants
|
|
Incidence of Lab Abnormalities
Urine blood/Hemoglobin (N=136)
|
34 participants
|
|
Incidence of Lab Abnormalities
Urine ketones (N=136)
|
32 participants
|
|
Incidence of Lab Abnormalities
Testosterone (N=134)
|
22 participants
|
|
Incidence of Lab Abnormalities
Urine specific gravity (N=136)
|
13 participants
|
|
Incidence of Lab Abnormalities
Urine red blood cells (N=136)
|
13 participants
|
|
Incidence of Lab Abnormalities
Monocytes (N=134)
|
9 participants
|
|
Incidence of Lab Abnormalities
Triglycerides (N=136)
|
10 participants
|
|
Incidence of Lab Abnormalities
Urine white blood cells (N=136)
|
10 participants
|
|
Incidence of Lab Abnormalities
Insulin (N=115)
|
8 participants
|
PRIMARY outcome
Timeframe: Week 6, Week 26Population: The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)
Mean Change: lab value at observation minus lab value at baseline.
Outcome measures
| Measure |
Ziprasidone
n=134 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
LDL cholesterol Week 6 (n=113)
|
-7.5 milligram /deciliter (mg/dL)
Standard Deviation 19.7
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
LDL cholesterol Week 26 (n=59)
|
-8.9 milligram /deciliter (mg/dL)
Standard Deviation 19.5
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
LDL cholesterol Early Termination (n=44)
|
-7.6 milligram /deciliter (mg/dL)
Standard Deviation 20.1
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
Fasting cholesterol Week 6 (n=113)
|
-7.7 milligram /deciliter (mg/dL)
Standard Deviation 21.8
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
Fasting cholesterol Week 26 (n=59)
|
-10.3 milligram /deciliter (mg/dL)
Standard Deviation 22.7
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
Fasting cholesterol Early Termination (n=44)
|
-8.6 milligram /deciliter (mg/dL)
Standard Deviation 24.9
|
PRIMARY outcome
Timeframe: Week 6, Week 26Population: The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)
Mean Change: lab value at observation minus lab value at baseline
Outcome measures
| Measure |
Ziprasidone
n=131 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
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Change in Hormones
Testosterone Week 6 (n=80)
|
0.9 nanogram/deciliter (ng/dL)
Standard Deviation 84.3
|
|
Change in Hormones
Testosterone Week 26 (n=38)
|
-23.4 nanogram/deciliter (ng/dL)
Standard Deviation 112.9
|
|
Change in Hormones
Testosterone Early Termination (n=32)
|
-0.4 nanogram/deciliter (ng/dL)
Standard Deviation 61.8
|
|
Change in Hormones
Prolactin Week 6 (n=110)
|
2.7 nanogram/deciliter (ng/dL)
Standard Deviation 13.2
|
|
Change in Hormones
Prolactin Week 26 (n=59)
|
1.9 nanogram/deciliter (ng/dL)
Standard Deviation 8.5
|
|
Change in Hormones
Prolactin Early Termination (n=40)
|
1.0 nanogram/deciliter (ng/dL)
Standard Deviation 11.6
|
|
Change in Hormones
Insulin-like growth factor Week 6 (n=95)
|
-19.9 nanogram/deciliter (ng/dL)
Standard Deviation 63.4
|
|
Change in Hormones
Insulin-like growth factor Week 26 (n=47)
|
-9.2 nanogram/deciliter (ng/dL)
Standard Deviation 68.1
|
|
Change in Hormones
Insulin-like growth factor Early Term (n=34)
|
-8.4 nanogram/deciliter (ng/dL)
Standard Deviation 66.5
|
PRIMARY outcome
Timeframe: Week 1 through Week 26Mean Change: vital sign value at observation minus vital sign value at baseline
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 1 (n=155)
|
0.4 millimeters of mercury (mm Hg)
Standard Deviation 11.4
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 2 (n=142)
|
1.1 millimeters of mercury (mm Hg)
Standard Deviation 10.4
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 6/pre-dose (n=115)
|
1.2 millimeters of mercury (mm Hg)
Standard Deviation 9.5
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 6/5-7 hours post dose (n=108)
|
1.2 millimeters of mercury (mm Hg)
Standard Deviation 9.9
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 10 (n=93)
|
1.4 millimeters of mercury (mm Hg)
Standard Deviation 10.1
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 14 (n=82)
|
-0.7 millimeters of mercury (mm Hg)
Standard Deviation 10.1
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 18 (n=74)
|
0.4 millimeters of mercury (mm Hg)
Standard Deviation 11.7
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 22 (n=69)
|
1.7 millimeters of mercury (mm Hg)
Standard Deviation 10.5
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Week 26 (n=68)
|
2.9 millimeters of mercury (mm Hg)
Standard Deviation 11.4
|
|
Mean Change From Baseline in Supine Systolic Blood Pressure
Early Termination (n=75)
|
1.3 millimeters of mercury (mm Hg)
Standard Deviation 11.8
|
PRIMARY outcome
Timeframe: Week 1 through Week 26Mean Change: vital sign value at observation minus vital sign value at baseline
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 1 (n=155)
|
-0.5 millimeters mercury (mm Hg)
Standard Deviation 8.8
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 2 (n=142)
|
0.5 millimeters mercury (mm Hg)
Standard Deviation 8.7
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 6/pre-dose (n=115)
|
0.6 millimeters mercury (mm Hg)
Standard Deviation 9.7
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 6/5-7 hours post dose (n=108)
|
0.5 millimeters mercury (mm Hg)
Standard Deviation 8.8
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 10 (n=93)
|
-0.4 millimeters mercury (mm Hg)
Standard Deviation 10.1
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 14 (n=82)
|
-2.4 millimeters mercury (mm Hg)
Standard Deviation 8.3
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 18 (n=74)
|
-0.6 millimeters mercury (mm Hg)
Standard Deviation 9.8
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 22 (n=69)
|
-0.7 millimeters mercury (mm Hg)
Standard Deviation 9.4
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Week 26 (n=68)
|
1.5 millimeters mercury (mm Hg)
Standard Deviation 10.4
|
|
Mean Change From Baseline in Supine Diastolic Blood Pressure
Early Termination (n=75)
|
1.3 millimeters mercury (mm Hg)
Standard Deviation 8.1
|
PRIMARY outcome
Timeframe: Week 1 through Week 26Mean Change: vital sign value at observation minus vital sign value at baseline
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline in Supine Pulse Rates
Week 1 (n=155)
|
1.4 beats per minute
Standard Deviation 12.4
|
|
Mean Change From Baseline in Supine Pulse Rates
Week 2 (n=142)
|
2.0 beats per minute
Standard Deviation 11.7
|
|
Mean Change From Baseline in Supine Pulse Rates
Week 6/pre-dose (n=115)
|
-1.8 beats per minute
Standard Deviation 11.6
|
|
Mean Change From Baseline in Supine Pulse Rates
Week 6/5-7 hours post dose (n=108)
|
1.0 beats per minute
Standard Deviation 12.3
|
|
Mean Change From Baseline in Supine Pulse Rates
Week 10 (n=93)
|
1.4 beats per minute
Standard Deviation 11.8
|
|
Mean Change From Baseline in Supine Pulse Rates
Week 14 (n=82)
|
-3.0 beats per minute
Standard Deviation 12.4
|
|
Mean Change From Baseline in Supine Pulse Rates
Week 18 (n=74)
|
-3.5 beats per minute
Standard Deviation 12.2
|
|
Mean Change From Baseline in Supine Pulse Rates
Week 22 (n=69)
|
-2.1 beats per minute
Standard Deviation 11.7
|
|
Mean Change From Baseline in Supine Pulse Rates
Week 26 (n=68)
|
-3.0 beats per minute
Standard Deviation 11.2
|
|
Mean Change From Baseline in Supine Pulse Rates
Early Termination (n=75)
|
3.9 beats per minute
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: Week 1 through Week 26Mean Change: vital sign value at observation minus vital sign value at baseline
Outcome measures
| Measure |
Ziprasidone
n=161 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 2 (n=141)
|
3.7 mm Hg
Standard Deviation 11.7
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 6/pre-dose (n=115)
|
1.6 mm Hg
Standard Deviation 9.6
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 6/5-7 hours post dose (n=108)
|
2.0 mm Hg
Standard Deviation 9.5
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Early Termination (n=75)
|
3.0 mm Hg
Standard Deviation 11.4
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 1 (n=154)
|
1.4 mm Hg
Standard Deviation 10.5
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 10 (n=93)
|
2.4 mm Hg
Standard Deviation 11.0
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 14 (n=82)
|
0.5 mm Hg
Standard Deviation 11.3
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 18 (n=74)
|
3.1 mm Hg
Standard Deviation 10.5
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 22 (n=70)
|
3.2 mm Hg
Standard Deviation 10.0
|
|
Mean Change From Baseline in Standing Systolic Blood Pressure
Week 26 (n=68)
|
3.6 mm Hg
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: Week 1 through Week 26Mean Change: vital sign value at observation minus vital sign value at baseline
Outcome measures
| Measure |
Ziprasidone
n=161 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 1 (n=154)
|
0.7 mm Hg
Standard Deviation 9.1
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 2 (n=141)
|
2.0 mm Hg
Standard Deviation 9.8
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 6/pre-dose (n=115)
|
1.4 mm Hg
Standard Deviation 9.8
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 6/5-7 hours post dose (n=108)
|
1.2 mm Hg
Standard Deviation 9.9
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 10 (n=93)
|
1.6 mm Hg
Standard Deviation 10.8
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 14 (n=82)
|
-0.1 mm Hg
Standard Deviation 9.8
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 18 (n=74)
|
1.1 mm Hg
Standard Deviation 8.8
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 22 (n=70)
|
0.5 mm Hg
Standard Deviation 8.5
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Week 26 (n=68)
|
2.8 mm Hg
Standard Deviation 8.3
|
|
Mean Change From Baseline in Standing Diastolic Blood Pressure
Early Termination (n=75)
|
3.4 mm Hg
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: Week 1 through Week 26Mean Change: vital sign value at observation minus vital sign value at baseline
Outcome measures
| Measure |
Ziprasidone
n=161 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline in Standing Pulse Rates
Week 1 (n=154)
|
3.5 beats per minute
Standard Deviation 14.0
|
|
Mean Change From Baseline in Standing Pulse Rates
Week 2 (n=140)
|
2.9 beats per minute
Standard Deviation 13.4
|
|
Mean Change From Baseline in Standing Pulse Rates
Week 6/pre-dose (n=115)
|
0.3 beats per minute
Standard Deviation 13.1
|
|
Mean Change From Baseline in Standing Pulse Rates
Week 6/5-7 hours post dose (n=108)
|
3.8 beats per minute
Standard Deviation 13.9
|
|
Mean Change From Baseline in Standing Pulse Rates
Week 10 (n=93)
|
2.6 beats per minute
Standard Deviation 14.5
|
|
Mean Change From Baseline in Standing Pulse Rates
Week 14 (n=82)
|
0.5 beats per minute
Standard Deviation 14.7
|
|
Mean Change From Baseline in Standing Pulse Rates
Week 18 (n=74)
|
-0.3 beats per minute
Standard Deviation 12.5
|
|
Mean Change From Baseline in Standing Pulse Rates
Week 22 (n=70)
|
1.2 beats per minute
Standard Deviation 14.7
|
|
Mean Change From Baseline in Standing Pulse Rates
Week 26 (n=68)
|
-0.9 beats per minute
Standard Deviation 12.9
|
|
Mean Change From Baseline in Standing Pulse Rates
Early Termination (n=75)
|
4.8 beats per minute
Standard Deviation 13.8
|
PRIMARY outcome
Timeframe: Week 6, Week 26Mean change; body weight value at observation minus body weight value at baseline.
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline for Body Weight
Week 26 (n=68)
|
3.9 kilogram
Standard Deviation 5.4
|
|
Mean Change From Baseline for Body Weight
Week 6 (n=119)
|
1.3 kilogram
Standard Deviation 3.0
|
|
Mean Change From Baseline for Body Weight
Early Termination (n=74)
|
1.4 kilogram
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Week 6, 26, early terminationmean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline for Body Mass Index (BMI) Z-Score
Week 26 (n=68)
|
0.1 score on scale
Standard Deviation 0.5
|
|
Mean Change From Baseline for Body Mass Index (BMI) Z-Score
Early Termination (n=74)
|
0.0 score on scale
Standard Deviation 0.3
|
|
Mean Change From Baseline for Body Mass Index (BMI) Z-Score
Week 6 (n=119)
|
0.0 score on scale
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Week 6change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Body Mass Index (BMI) Z-score Frequency
<-4
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥-4 to <-3
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥-3 to <-2
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥-2 to <-1
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥-1 to <0
|
53 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥0 to <1
|
61 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥1 to <2
|
1 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥2 to <3
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥3 to <4
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥4
|
0 participants
|
PRIMARY outcome
Timeframe: Week 26change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Body Mass Index (BMI) Z-score Frequency
≥-3 to <-2
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥-2 to <-1
|
1 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥-1 to <0
|
27 participants
|
|
Body Mass Index (BMI) Z-score Frequency
<-4
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥-4 to <-3
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥0 to <1
|
39 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥1 to <2
|
1 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥2 to <3
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥3 to <4
|
0 participants
|
|
Body Mass Index (BMI) Z-score Frequency
≥4
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (end of study)QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.
Outcome measures
| Measure |
Ziprasidone
n=162 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Mean Change From Baseline for QTcF Intervals
Week 1 (n=152)
|
4.8 millisecond
Standard Deviation 18.5
|
|
Mean Change From Baseline for QTcF Intervals
Week 2 (n=137)
|
3.5 millisecond
Standard Deviation 17.7
|
|
Mean Change From Baseline for QTcF Intervals
Week 6/pre-dose (n=111)
|
7.6 millisecond
Standard Deviation 17.7
|
|
Mean Change From Baseline for QTcF Intervals
Week 6/5-7 hours post dose (n=107)
|
7.0 millisecond
Standard Deviation 18.4
|
|
Mean Change From Baseline for QTcF Intervals
Week 10 (n=91)
|
4.3 millisecond
Standard Deviation 18.8
|
|
Mean Change From Baseline for QTcF Intervals
Week 14 (n=81)
|
6.2 millisecond
Standard Deviation 17.4
|
|
Mean Change From Baseline for QTcF Intervals
Week 18 (n=73)
|
7.4 millisecond
Standard Deviation 15.4
|
|
Mean Change From Baseline for QTcF Intervals
Week 22 (n=68)
|
8.1 millisecond
Standard Deviation 16.1
|
|
Mean Change From Baseline for QTcF Intervals
Week 26 (n=64)
|
7.1 millisecond
Standard Deviation 15.2
|
|
Mean Change From Baseline for QTcF Intervals
Early Termination (n=45)
|
2.7 millisecond
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: Week 26 (end of study)QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Outcome measures
| Measure |
Ziprasidone
n=89 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Frequency of Largest Categorical Increases in QTcF for Males
≥450 msec (millisecond )
|
0 participants
|
|
Frequency of Largest Categorical Increases in QTcF for Males
≥460 msec
|
0 participants
|
|
Frequency of Largest Categorical Increases in QTcF for Males
≥480 msec
|
0 participants
|
|
Frequency of Largest Categorical Increases in QTcF for Males
≥30 msec increase
|
28 participants
|
|
Frequency of Largest Categorical Increases in QTcF for Males
≥60 msec increase
|
0 participants
|
PRIMARY outcome
Timeframe: Week 26 (end of study)QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Outcome measures
| Measure |
Ziprasidone
n=71 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Frequency of Largest Categorical Increases in QTcF for Females
≥450 msec (millisecond)
|
3 participants
|
|
Frequency of Largest Categorical Increases in QTcF for Females
≥460 msec
|
0 participants
|
|
Frequency of Largest Categorical Increases in QTcF for Females
≥480 msec
|
0 participants
|
|
Frequency of Largest Categorical Increases in QTcF for Females
≥30 msec increase
|
10 participants
|
|
Frequency of Largest Categorical Increases in QTcF for Females
≥60 msec increase
|
2 participants
|
PRIMARY outcome
Timeframe: Week 26 (end of study)QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Outcome measures
| Measure |
Ziprasidone
n=160 Participants
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Frequency of Largest Categorical Increases in QTcF - All Subjects
≥450 msec (millisecond)
|
3 participants
|
|
Frequency of Largest Categorical Increases in QTcF - All Subjects
≥460 msec
|
0 participants
|
|
Frequency of Largest Categorical Increases in QTcF - All Subjects
≥480 msec
|
0 participants
|
|
Frequency of Largest Categorical Increases in QTcF - All Subjects
≥30 msec increase
|
38 participants
|
|
Frequency of Largest Categorical Increases in QTcF - All Subjects
≥60 msec increase
|
2 participants
|
Adverse Events
Ziprasidone
Serious events: 17 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ziprasidone
n=162 participants at risk
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Aggression
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Bipolar disorder
|
1.9%
3/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Conversion disorder
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Delusion
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Homicidal ideation
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Mania
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Negative thoughts
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Oppositional defiant disorder
|
1.2%
2/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Self-injurious behavior
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Suicidal ideation
|
2.5%
4/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Disease progression
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Hallucination
|
0.62%
1/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
Other adverse events
| Measure |
Ziprasidone
n=162 participants at risk
Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.3%
15/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
13/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
12/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Fatigue
|
6.8%
11/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dizziness
|
7.4%
12/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Headache
|
22.2%
36/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Sedation
|
26.5%
43/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Somnolence
|
23.5%
38/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Insomnia
|
13.6%
22/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
9/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.4%
12/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.8%
11/162 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
Additional Information
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