| Primary | Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase | Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology. | Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12. Last Observation Carried Forward | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on scale | | Baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Sertraline | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | | OG001 | Paroxetine | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-17.4(-18.9 to -15.9)
- OG001-17.0(-18.4 to -15.5)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group - paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate. | ANCOVA | | | | Mean Difference (Final Values) | -0.4 | | | 2-Sided | 95 | -2.5 | 1.6 | | | | | Non-Inferiority or Equivalence (legacy) | Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4. |
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| Secondary | Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement | The ratings were rated to compare with baseline by 7-point " 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse". Responder was defined as number of participants who were assessed as "very much improved" or " much improved". | Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12. Last Observation Carried Forward | Posted | | Number | | Percentage of participants | | 12 weeks | | | | ID | Title | Description |
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| OG000 | Sertraline | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | | OG001 | Paroxetine | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
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| Secondary | Mean Change From Baseline in Panic Attack at the End of Treatment Phase | Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills. | Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12. Last Observation Carried Forward | Posted | | Mean | Standard Deviation | panic attacks per week | | Baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Sertraline | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. |
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| Secondary | Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase | The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items. The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52. | Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12. Last Observation Carried Forward | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and 12 weeks | | | | ID | Title | Description |
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| OG000 | Sertraline | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | | OG001 | Paroxetine | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
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| Secondary | Number of Participants With Summary of Adverse Events in Treatment Phase | Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row. | The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug. | Posted | | Number | | Participants | | 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug | | | | ID | Title | Description |
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| OG000 | Sertraline | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | | OG001 | Paroxetine | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
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| Secondary | Summary of Adverse Events in Tapering Phase | Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row. | The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug. | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Sertraline | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | | OG001 | Paroxetine | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
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| Secondary | Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase | The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group. | Completer Set : Subset of patients in the EES who had a PAS rating at Week 16. | Posted | | Number | | Percentage of participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Sertraline | Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day. At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks. | | OG001 | Paroxetine | Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day. At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks. |
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