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Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug regarding long time use.
All the patients for whom an investigator prescribes the first sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline hydrochloride. | Patients taking Sertraline hydrochloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline hydrochloride | Drug | J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan. Dosage, Frequency: According to Japanese LPD, "The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms". Duration: According to the protocol of A0501091, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 52 weeks after the first administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Baseline up to 52 weeks | |
| Number of Participants of Treatment Related Adverse Events (TRAEs) | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. | Baseline up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor | Baseline up to 52 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness |
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Inclusion Criteria:
The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).
Exclusion Criteria:
Patients not taking sertraline hydrochloride.
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The patients to whom an investigator involved in A0501091 prescribes sertraline hydrochloride.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline | Participants taking Sertraline according to Japanese Package Insert |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertraline | Participants taking Sertraline according to Japanese Package Insert |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | events | Baseline up to 52 weeks |
|
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sertraline | Participants taking Sertraline according to Japanese Package Insert |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dissociative disorder | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
|
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor |
| Baseline up to 52 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies | Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor | Baseline up to 52 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt) | Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor | Baseline up to 52 weeks |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Target Disease | The target disease which was diagnosed by investigator | Number | participants |
|
| Target Disease Severity | The severity of target disease which was diagnosed by investigator | Number | participants |
|
| Complications | Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | Number | participants |
|
| Concomitant Drug | Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) | Number | participants |
|
| Starting Dose | Starting dose of each participant enrolled in this study | Number | participants |
|
|
| Primary | Number of Participants of Treatment Related Adverse Events (TRAEs) | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. | Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Sertraline. | Posted | Number | events | Baseline up to 52 weeks |
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies | Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt) | Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 52 weeks |
|
|
|
|
| 2 |
| 517 |
| 44 |
| 517 |
| Completed suicide | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/14.1 | Systematic Assessment |
|
| Ejaculation delayed | Reproductive system and breast disorders | MedDRA/14.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA/14.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dissociative disorder | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA/14.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA/14.1 | Systematic Assessment |
|
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.
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |