Smoking Cessation
Conditions
Brief summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 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 Varenicline(Champix) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Interventions
DRUGVarenicline
Champix Tablets 0.5mg or Champix Tablets 1mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage for oral use is 0.5 mg of varenicline once daily after eating for days 1 to 3, 0.5 mg twice daily after eating in the morning and evening for days 4 to 7, and 1 mg twice daily after eating in the morning and evening on and after day 8. The drug should be administered to patients for 12 weeks.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.
Exclusion criteria
* Patients not administered Varenicline(Champix).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. | 24 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks. |
| Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor. |
| Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor. |
| Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor. |
| Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor. |
| Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor. |
| Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 24 weeks | Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor. |
| Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day. | 24 weeks | The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks. | 24 weeks | The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug. | 24 weeks | The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Number of Participants With Treatment Related Adverse Events. | 24 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Continuous Abstinence Situation by 52 Weeks. | 52 weeks | Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Participants taking Varenicline according to Japanese Package Insert. | 3,257 |
| Total | 3,257 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | CRFs not available | 195 |
| Overall Study | GPSP Violation | 90 |
| Overall Study | Missed Visits | 374 |
| Overall Study | Poor Compliance | 7 |
| Overall Study | Study not completed | 16 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age, Customized <65 years | 2768 Participants |
| Age, Customized >=65 years | 489 Participants |
| Sex: Female, Male Female | 1078 Participants |
| Sex: Female, Male Male | 2179 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 708 / 3,257 |
| serious Total, serious adverse events | 8 / 3,257 |
Outcome results
Primary
Number of Participants With Treatment Related Adverse Events.
Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Time frame: 24 weeks
Population: No statistical analysis provided for the frequency of treatment related adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Number of Participants With Treatment Related Adverse Events. | 713 participants |
Primary
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Time frame: 24 weeks
Population: No statistical analysis provided for the frequency of unlisted treatment related adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. | 30 events |
Primary
Risk Factors for the Frequency of Treatment Related Adverse Events - Age.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.
Time frame: 24 weeks
Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | 571 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | 142 participants |
Comparison: The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of Treatment Related Adverse Events.p-value: <0.001Chi-squared
Primary
Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.
Time frame: 24 weeks
Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | 23 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | 690 participants |
Comparison: The risk factor tested was Chronic obstructive pulmonary disease as a complication. The null hypothesis is that there is no difference between Varenicline with and without Chronic obstructive pulmonary disease as a complication in the frequency of Treatment Related Adverse Events.p-value: <0.001Chi-squared
Primary
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.
Time frame: 24 weeks
Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | 289 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | 424 participants |
Comparison: The risk factor tested was concomitant drugs. The null hypothesis is that there is no difference between Varenicline with and without concomitant drugs in the frequency of Treatment Related Adverse Events.p-value: <0.001Chi-squared
Primary
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.
Time frame: 24 weeks
Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | 45 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | 668 participants |
Comparison: The risk factor tested was concomitant therapies. The null hypothesis is that there is no difference between Varenicline with and without concomitant therapies in the frequency of Treatment Related Adverse Events.p-value: <0.001Chi-squared
Primary
Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.
Time frame: 24 weeks
Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | 377 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | 336 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of Treatment Related Adverse Events.p-value: <0.001Chi-squared
Primary
Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.
Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.
Time frame: 24 weeks
Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 6 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 98 participants |
| >=50 kg and <60 kg at Baseline | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 135 participants |
| >=60 kg and <70 kg at Baseline | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 110 participants |
| >=70 kg and <80 kg at Baseline | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 61 participants |
| >= 80 kg at Baseline | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 31 participants |
Comparison: The risk factor tested was Weight at Baseline. The null hypothesis is that there is no association between Weight at Baseline and the frequency of Treatment Related Adverse Events.p-value: <0.001Chi-squared
Comparison: The risk factor tested was Weight at Baseline. The null hypothesis is that there is no linear trend in the frequency of Treatment Related Adverse Events across increasing levels of Weight at Baseline.p-value: <0.001Cochran-Armitage
Primary
Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.
The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Time frame: 24 weeks
Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug. | 85 participants |
| Female | Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug. | 2111 participants |
Comparison: The risk factor tested was antipsychotics as a concomitant drug. The null hypothesis is that there is no difference between Varenicline with and without antipsychotics as a concomitant drug in the efficacy of Varenicline.p-value: <0.001Chi-squared
Primary
Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.
The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Time frame: 24 weeks
Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks. | 39 participants |
| Female | Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks. | 1993 participants |
Comparison: The risk factor tested was prolonged administration after 12 weeks. The null hypothesis is that there is no difference between administration prolonged after 12 weeks and administration not prolonged after 12 weeks in the efficacy of Varenicline.p-value: <0.001Chi-squared
Primary
Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.
The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Time frame: 24 weeks
Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day. | 1299 participants |
| Female | Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day. | 817 participants |
| >=50 kg and <60 kg at Baseline | Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day. | 66 participants |
Comparison: The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no association between Tobacco consumption per day and the efficacy of Varenicline.p-value: <0.001Chi-squared
Comparison: The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no linear trend in the efficacy of Varenicline across increasing levels of tobacco consumption per day.p-value: <0.001Cochran-Armitage
Secondary
Number of Participants With Continuous Abstinence Situation by 52 Weeks.
Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.
Time frame: 52 weeks
Population: No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Male | Number of Participants With Continuous Abstinence Situation by 52 Weeks. | 38 participants |