Panic Disorder, Depression
Conditions
Brief summary
The objective of this surveillance 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.
Detailed description
All the patients 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 A0501090, the duration of the investigation for findings regarding safety and efficacy of a 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 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 16 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 16 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction 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 16 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: Average Daily Dose | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor |
| Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity | Baseline up to 16 weeks | Number of participants with responders of Sertraline to determine whether target disease severity is significant factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Baseline up to 16 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: Outpatient/Inpatient | Baseline up to 16 weeks | Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor |
| Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments. | Baseline up to 16 weeks | Number of participants with responders of Sertraline to determine whether with or without complication is significant factor |
| Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not | Baseline up to 16 weeks | Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor |
| Factors Considered to Affect the Efficacy of Sertraline: Age | Baseline up to 16 weeks | Number of participants with responders of Sertraline to determine whether age is significant factor |
| Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Baseline up to 16 weeks | Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor |
| Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride | Baseline up to 16 weeks | Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Baseline up to 16 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 | 2,157 |
| Total | 2,157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 115 |
Baseline characteristics
| Characteristic | Sertraline |
|---|---|
| Age, Customized <65 years | 1820 participants |
| Age, Customized >=65 years | 337 participants |
| Complications Absent | 1380 participants |
| Complications Present | 777 participants |
| Concomitant Drug Absent | 283 participants |
| Concomitant Drug Present | 1874 participants |
| Sex: Female, Male Female | 1289 Participants |
| Sex: Female, Male Male | 868 Participants |
| Starting Dose 100 mg | 31 participants |
| Starting Dose 25 mg | 1530 participants |
| Starting Dose 50 mg | 523 participants |
| Starting Dose 75 mg | 33 participants |
| Starting Dose Other than Those Above | 40 participants |
| Target Disease Depression/Depressed State | 1870 participants |
| Target Disease Depression/Depressed state and Panic Disorder | 56 participants |
| Target Disease Other than Those Above | 81 participants |
| Target Disease Panic Disorder | 150 participants |
| Target Disease Severity Mild | 568 participants |
| Target Disease Severity Moderate | 1423 participants |
| Target Disease Severity Severe | 166 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 263 / 2,157 |
| serious Total, serious adverse events | 9 / 2,157 |
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 16 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) | 263 participants |
Primary
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Time frame: Baseline up to 16 weeks
Population: The safety analysis population consists of the cases that satisfy the participant's 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 | Dyspnoea | 3 events |
| Sertraline | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Gastritis | 3 events |
| Sertraline | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Sedation | 2 events |
| Sertraline | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Erectile dysfunction | 2 events |
Secondary
Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not
Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor
Time frame: Baseline up to 16 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: 15 Years and Higher of Age or Not | 1508 participants |
| Without Complications | Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not | 1 participants |
Comparison: The factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders.p-value: 0.01Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Age
Number of participants with responders of Sertraline to determine whether age is significant factor
Time frame: Baseline up to 16 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: Age | 23 participants |
| Without Complications | Factors Considered to Affect the Efficacy of Sertraline: Age | 829 participants |
| >=50mg, <75mg | Factors Considered to Affect the Efficacy of Sertraline: Age | 412 participants |
| >=75mg, <100mg | Factors Considered to Affect the Efficacy of Sertraline: Age | 245 participants |
Comparison: The factor tested was age. The null hypothesis is there is no difference between four groups of age in the participants of responders.p-value: 0.015Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.
Number of participants with responders of Sertraline to determine whether with or without complication is significant factor
Time frame: Baseline up to 16 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 ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments. | 528 participants |
| Without Complications | Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments. | 981 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: 0.019Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride
Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor
Time frame: Baseline up to 16 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: History of Treatment Prior to Administration of Sertraline Hydrochloride | 398 participants |
| Without Complications | Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride | 1046 participants |
Comparison: The factor tested was history of treatment prior to Sertralin. The null hypothesis is there is no difference between with and without history of treatment prior to Sertralin in the participants of responders.p-value: 0.003Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient
Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor
Time frame: Baseline up to 16 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: Outpatient/Inpatient | 99 participants |
| Without Complications | Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient | 1410 participants |
Comparison: The factor tested was outpatient or inpatient. The null hypothesis is there is no difference between outpatient or inpatient in the participants of responders.p-value: 0.012Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)
Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor
Time frame: Baseline up to 16 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: Suicidal Ideation (Including Suicide Attempt) | 319 participants |
| Without Complications | Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt) | 1136 participants |
Comparison: The factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with or without suicidal ideation (including suicide attempt) in the participants of responders.p-value: <0.001Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity
Number of participants with responders of Sertraline to determine whether target disease severity is significant factor
Time frame: Baseline up to 16 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: Target Disease Severity | 416 participants |
| Without Complications | Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity | 1000 participants |
| >=50mg, <75mg | Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity | 93 participants |
Comparison: The factor tested was target disease severity. The null hypothesis is there is no difference between three grade of target disease severity in the participants of responders.p-value: <0.001Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor
Time frame: Baseline up to 16 weeks
Population: The safety analysis population consists of the cases that satisfy the participant's 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: 15 Years and Higher of Age or Not | 261 participants |
| Without Complications | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not | 2 participants |
Comparison: The risk factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders.p-value: 0.021Chi-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 average daily dose is significant risk factor
Time frame: Baseline up to 16 weeks
Population: The safety analysis population consists of the cases that satisfy the participant's 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 | 6 participants |
| Without Complications | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 175 participants |
| >=50mg, <75mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 61 participants |
| >=75mg, <100mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 20 participants |
| >=100mg | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | 1 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 16 weeks
Population: The safety analysis population consists of the cases that satisfy the participant's 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 | 129 participants |
| Without Complications | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | 134 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: <0.001Chi-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 16 weeks
Population: The safety analysis population consists of the cases that satisfy the participant's 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 | 238 participants |
| Without Complications | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | 25 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: 0.039Chi-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 16 weeks
Population: The safety analysis population consists of the cases that satisfy the participant's 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 | 57 participants |
| Without Complications | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | 206 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: 0.01Chi-squared
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 Sertraline to determine whether with or without renal dysfunction is significant risk factor
Time frame: Baseline up to 16 weeks
Population: The safety analysis population consists of the cases that satisfy the participant's 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: Renal Dysfunction | 7 participants |
| Without Complications | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | 256 participants |
Comparison: The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders.p-value: 0.011Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor
Time frame: Baseline up to 16 weeks
Population: The safety analysis population consists of the cases that satisfy the participant's 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: Suicidal Ideation (Including Suicide Attempt) | 73 participants |
| Without Complications | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) | 182 participants |
Comparison: The risk factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with and without suicidal ideation(including suicide attempt) in the participants of responders.p-value: 0.014Chi-squared