Trial Outcomes & Findings for A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule (NCT NCT01053429)
NCT ID: NCT01053429
Last Updated: 2021-03-03
Results Overview
CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.
Recruitment status
COMPLETED
Target enrollment
3391 participants
Primary outcome timeframe
Baseline up to Week 8
Results posted on
2021-03-03
Participant Flow
Pediatric patients \<18 years of age (N=105) were enrolled in error by some sites and were subsequently reported as protocol violations. Given that the objective of this Non-interventional study was to observe the safety and efficacy of Zeldox in real life, the data collected from these participants was included in the safety and efficacy analyses.
Participant milestones
| Measure |
Ziprasidone HCl (Zeldox)
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
Overall Study
STARTED
|
3391
|
|
Overall Study
COMPLETED
|
3018
|
|
Overall Study
NOT COMPLETED
|
373
|
Reasons for withdrawal
| Measure |
Ziprasidone HCl (Zeldox)
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
Overall Study
Adverse Event
|
64
|
|
Overall Study
Other
|
309
|
Baseline Characteristics
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
Baseline characteristics by cohort
| Measure |
Ziprasidone HCl (Zeldox)
n=3391 Participants
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
Age, Customized
<18 years
|
105 participants
n=93 Participants
|
|
Age, Customized
Between 18 and 44 years
|
2377 participants
n=93 Participants
|
|
Age, Customized
Between 45 and 64 years
|
723 participants
n=93 Participants
|
|
Age, Customized
>=65 years
|
186 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1926 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1465 Participants
n=93 Participants
|
|
Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT)
Normal, not ill at all
|
6 participants
n=93 Participants
|
|
Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT)
Borderline mentally ill
|
110 participants
n=93 Participants
|
|
Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT)
Mildly ill
|
669 participants
n=93 Participants
|
|
Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT)
Moderately ill
|
1264 participants
n=93 Participants
|
|
Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT)
Markedly ill
|
808 participants
n=93 Participants
|
|
Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT)
Severely ill
|
440 participants
n=93 Participants
|
|
Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT)
Among the most extremely ill
|
54 participants
n=93 Participants
|
|
CGI-S status - Per protocol population (PP)
Normal, not ill at all
|
3 participants
n=93 Participants
|
|
CGI-S status - Per protocol population (PP)
Borderline mentally ill
|
68 participants
n=93 Participants
|
|
CGI-S status - Per protocol population (PP)
Mildly ill
|
454 participants
n=93 Participants
|
|
CGI-S status - Per protocol population (PP)
Moderately ill
|
877 participants
n=93 Participants
|
|
CGI-S status - Per protocol population (PP)
Markedly ill
|
547 participants
n=93 Participants
|
|
CGI-S status - Per protocol population (PP)
Severely ill
|
266 participants
n=93 Participants
|
|
CGI-S status - Per protocol population (PP)
Among the most extremely ill
|
39 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 8Population: Intent to treat population (ITT): administered at least 1 dose of study treatment at least once a week and observed for at least 1 efficacy assessment. N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).
CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.
Outcome measures
| Measure |
Ziprasidone HCl (Zeldox)
n=3351 Participants
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
Borderline mentally ill
|
1125 particpants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
Mildly ill
|
1325 particpants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
Normal, not ill at all
|
190 particpants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
Moderately ill
|
506 particpants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
Markedly ill
|
156 particpants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
Severely ill
|
46 particpants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
Among the most extremely ill
|
3 particpants
|
PRIMARY outcome
Timeframe: Baseline up to Week 8Population: Per Protocol population (PP): participants in ITT group with study treatment for at least 8 (± 1 week) since enrollment and observed for final efficacy (inpatient visit or phone call). N=participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).
CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.
Outcome measures
| Measure |
Ziprasidone HCl (Zeldox)
n=2254 Participants
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
Normal, not ill at all
|
130 participants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
Borderline mentally ill
|
815 participants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
Mildly ill
|
889 participants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
Moderately ill
|
320 participants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
Markedly ill
|
77 participants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
Severely ill
|
21 participants
|
|
Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
Among the most extremely ill
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 8Population: ITT; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).
CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.
Outcome measures
| Measure |
Ziprasidone HCl (Zeldox)
n=3351 Participants
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
Very much improved
|
368 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
Much improved
|
1026 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
Minimally improved
|
1361 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
No change
|
512 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
Minimally worse
|
71 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
Much worse
|
13 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
Very much worse
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 8Population: PP; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).
CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.
Outcome measures
| Measure |
Ziprasidone HCl (Zeldox)
n=2254 Participants
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
Minimally improved
|
889 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
Very much improved
|
271 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
Much improved
|
751 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
No change
|
299 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
Minimally worse
|
36 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
Much worse
|
8 participants
|
|
Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
Very much worse
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 8Population: Safety analysis set: all participants who received at least 1 dose of study treatment. It was recommended to use the optional BPRS tool to gather additional information for the improvement score under usual practice. The optional BPRS tool was not used during the study.
BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 8Population: Safety analysis set. It was recommended to use the optional DAI-10 tool to gather additional information for the improvement score under usual practice. The optional DAI-10 tool was not used during the study.
DAI-10: a 10-item scale to assess how the attitude of participants with schizophrenia toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicates a positive subjective response (compliant); a negative score indicates non-compliance.
Outcome measures
Outcome data not reported
Adverse Events
Ziprasidone HCl (Zeldox)
Serious events: 2 serious events
Other events: 392 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ziprasidone HCl (Zeldox)
n=3391 participants at risk
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
General disorders
Asthenia
|
0.03%
1/3391
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.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.03%
1/3391
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.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.03%
1/3391
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
|
0.03%
1/3391
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
Psychotic disorder
|
0.03%
1/3391
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
Suicide attempt
|
0.03%
1/3391
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 HCl (Zeldox)
n=3391 participants at risk
Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.03%
1/3391
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.
|
|
Cardiac disorders
Palpitations
|
0.06%
2/3391
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.
|
|
Cardiac disorders
Tachycardia
|
0.03%
1/3391
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 pain
|
0.06%
2/3391
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
Constipation
|
0.38%
13/3391
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
Dyspepsia
|
0.12%
4/3391
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
Gastrointestinal disorder
|
0.03%
1/3391
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
|
0.71%
24/3391
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
Salivary hypersecretion
|
0.03%
1/3391
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
|
0.12%
4/3391
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
Asthenia
|
0.97%
33/3391
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
Drug ineffective
|
0.06%
2/3391
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
Gait disturbance
|
0.09%
3/3391
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
Pyrexia
|
0.03%
1/3391
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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3391
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.
|
|
Investigations
Weight decreased
|
0.03%
1/3391
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.
|
|
Investigations
Weight increased
|
0.03%
1/3391
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.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.09%
3/3391
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.03%
1/3391
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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.03%
1/3391
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.03%
1/3391
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
Akathisia
|
2.4%
80/3391
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
|
0.77%
26/3391
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
Dysarthria
|
0.09%
3/3391
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
Dystonia
|
0.41%
14/3391
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
Extrapyramidal disorder
|
2.0%
68/3391
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
|
0.59%
20/3391
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
Hypertonia
|
0.06%
2/3391
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
Hypokinesia
|
0.09%
3/3391
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
Memory impairment
|
0.06%
2/3391
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
Motor dysfunction
|
0.03%
1/3391
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
Paraesthesia
|
0.03%
1/3391
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
Paralysis
|
0.03%
1/3391
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
|
0.03%
1/3391
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
|
2.1%
72/3391
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
Tremor
|
0.35%
12/3391
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
Visual field defect
|
0.03%
1/3391
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
|
0.03%
1/3391
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
Agitation
|
0.24%
8/3391
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
Anxiety
|
1.2%
39/3391
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
Blunted affect
|
0.03%
1/3391
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
Drug dependence
|
0.03%
1/3391
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
|
0.12%
4/3391
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
|
1.7%
58/3391
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
Schizophrenia
|
0.03%
1/3391
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
Sleep disorder
|
0.06%
2/3391
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
Thinking abnormal
|
0.06%
2/3391
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.
|
|
Renal and urinary disorders
Dysuria
|
0.06%
2/3391
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
Nocturia
|
0.03%
1/3391
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.
|
|
Reproductive system and breast disorders
Mammary duct ectasia
|
0.03%
1/3391
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
Dyspnoea
|
0.06%
2/3391
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.03%
1/3391
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.12%
4/3391
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.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.03%
1/3391
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.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.06%
2/3391
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.
|
|
Vascular disorders
Hypotension
|
0.06%
2/3391
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.
|
|
Eye disorders
Oculogyric crisis
|
0.03%
1/3391
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.
|
|
Eye disorders
Vision blurred
|
0.18%
6/3391
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