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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline | Patients taking Varenicline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | 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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A3051109 prescribes the Varenicline(Champix).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Participants taking Varenicline according to Japanese Package Insert. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Participants taking Varenicline 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 | 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. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 24 weeks |
|
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The frequency of treatment related adverse events 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 | Varenicline | Participants taking Varenicline according to Japanese Package Insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes virus infection | Infections and infestations | MedDRA-J 15.1 | 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 |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 52 weeks |
| Poor Compliance |
|
| GPSP Violation |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 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. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 24 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 24 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 24 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 24 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | participants | 24 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | participants | 24 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | participants | 24 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | participants | 24 weeks |
|
|
|
|
| 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. | No statistical analysis provided for the frequency of treatment related adverse events. | Posted | Number | participants | 24 weeks |
|
|
|
| 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. | No statistical analysis provided for the frequency of unlisted treatment related adverse events. | Posted | Number | events | 24 weeks |
|
|
|
| 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. | No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events. | Posted | Number | participants | 52 weeks |
|
|
|
| 8 |
| 3,257 |
| 708 |
| 3,257 |
| Suicidal ideation | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Decreased activity | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Social avoidant behaviour | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Bulimia nervosa | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Terminal insomnia | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Lactation disorder | Reproductive system and breast disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA-J 15.1 | 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.
| D011810 | Quinoxalines |
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. |
| Cochran-Armitage |
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
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.
| Cochran-Armitage |
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |