Panic Disorder
Conditions
Brief summary
The objective of this surveillance is to collect information for panic disorder patients 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.
Detailed description
All patients with panic disorder to 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.
Interventions
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 A0501092, the duration of the investigation for findings regarding safety and efficacy of a panic disorder patient is from the first drug administration to the 16 weeks after the first administration.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with panic disorder need to be taking sertraline hydrochloride in order to be enrolled in the surveillance.
Exclusion criteria
Patients not taking sertraline hydrochloride.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants of Treatment Related Adverse Events (TRAEs) | Baseline up to 52 weeks | 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. |
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Baseline up to 52 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without past medical history of other illness is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, 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.) |
| Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug | Baseline up to 52 weeks | Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor |
| Factors Considered to Affect the Efficacy of Sertraline: Complication | Baseline up to 52 weeks | Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, 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.) |
| Factors Considered to Affect the Efficacy of Sertraline: Drinking Status | Baseline up to 52 weeks | Number of participants with responders of Sertraline to determine whether drinking status is significant factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, 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.) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sertraline Participants taking Sertraline according to Japanese Package Insert | 908 |
| Total | 908 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 79 |
Baseline characteristics
| Characteristic | Sertraline |
|---|---|
| Age, Customized <65 years | 863 participants |
| Age, Customized >=65 years | 45 participants |
| Complications Absent | 603 participants |
| Complications Present | 305 participants |
| Concomitant drug Absent | 237 participants |
| Concomitant drug Present | 671 participants |
| Sex: Female, Male Female | 592 Participants |
| Sex: Female, Male Male | 316 Participants |
| Starting dose 100 mg | 6 participants |
| Starting dose 25 mg | 699 participants |
| Starting dose 50 mg | 176 participants |
| Starting dose 75 mg | 18 participants |
| Starting dose other | 9 participants |
| Target Disease Severity Mild | 325 participants |
| Target Disease Severity Moderate | 511 participants |
| Target Disease Severity Severe | 72 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 110 / 908 |
| serious Total, serious adverse events | 1 / 908 |
Outcome results
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.
Time frame: Baseline up to 52 weeks
Population: Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Number of Participants of Treatment Related Adverse Events (TRAEs) | 110 participants |
Primary
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sertraline | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Sedation | 3 events |
| Sertraline | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Gastritis | 2 events |
| Sertraline | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Hyperuricaemia | 1 events |
| Sertraline | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Ventricular extrasystoles | 1 events |
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Complication
Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, 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.)
Time frame: Baseline up to 52 weeks
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Factors Considered to Affect the Efficacy of Sertraline: Complication | 246 participants |
| 50mg | Factors Considered to Affect the Efficacy of Sertraline: Complication | 535 participants |
Comparison: The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders.p-value: 0.004Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug
Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor
Time frame: Baseline up to 52 weeks
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug | 565 participants |
| 50mg | Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug | 216 participants |
Comparison: The factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders.p-value: 0.013Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Drinking Status
Number of participants with responders of Sertraline to determine whether drinking status is significant factor
Time frame: Baseline up to 52 weeks
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Factors Considered to Affect the Efficacy of Sertraline: Drinking Status | 171 participants |
| 50mg | Factors Considered to Affect the Efficacy of Sertraline: Drinking Status | 312 participants |
| 75mg | Factors Considered to Affect the Efficacy of Sertraline: Drinking Status | 23 participants |
| 100mg | Factors Considered to Affect the Efficacy of Sertraline: Drinking Status | 118 participants |
| Other Than Those Above | Factors Considered to Affect the Efficacy of Sertraline: Drinking Status | 53 participants |
Comparison: The factor tested was drinking status. The null hypothesis is there is no difference between five types of drinking status in the participants of responders.p-value: 0.004Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 2 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 92 participants |
| 75mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 14 participants |
| 100mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 2 participants |
| Other Than Those Above | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 0 participants |
Comparison: The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders.p-value: <0.001Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, 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.)
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | 47 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | 63 participants |
Comparison: The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders.p-value: 0.03Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, 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.)
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | 94 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | 16 participants |
Comparison: The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders.p-value: 0.002Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder | 11 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder | 78 participants |
Comparison: The risk factor tested was family history of psychiatric disorder. The null hypothesis is there is no difference between with and without family history of psychiatric disorder in the participants of responders.p-value: 0.032Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline | 33 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline | 73 participants |
Comparison: The risk factor tested was history of treatment prior to administration of Sertraline. The null hypothesis is there is no difference between with and without history of treatment prior to administration of Sertraline in the participants of responders.p-value: 0.028Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies | 65 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies | 45 participants |
Comparison: The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with and without non-pharmaceutical therapies in the participants of responders.p-value: 0.001Chi-squared
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 Sertraline to determine whether with or without past medical history of other illness is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | 25 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | 85 participants |
Comparison: The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders.p-value: <0.001Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status | 57 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status | 9 participants |
| 75mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status | 30 participants |
Comparison: The risk factor tested was smoking status. The null hypothesis is there is no difference between three types of smoking status in the participants of responders.p-value: <0.001Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose | 101 participants |
| 50mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose | 6 participants |
| 75mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose | 0 participants |
| 100mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose | 0 participants |
| Other Than Those Above | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose | 3 participants |
Comparison: The risk factor tested was starting dose. The null hypothesis is there is no difference between three types of starting dose in the participants of responders.p-value: <0.001Chi-squared